 DRAFT UGANDA STANDARD  
  DUS 883-2 
Second  Edition  
2021 -mm-dd 
 
 
 Reference number  
DUS 883: 2021 
© UNBS 2021   
  
Single -use medical examination gloves — Part 2: Specification 
for gloves made from poly (vinyl chloride)  
 DUS 883-2: 2021  
ii © UNBS 2021  – All rights reserved  
 Compliance with this standard does not, of itself confer immunity from legal obligations  
A Uganda Standard does not purport to include all necessary  provisions of a contract. Users are 
responsible for its correct application  
© UNBS 200 7  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any 
form or by any means, electronic or mechanical, incl uding photocopying and microfilm, without prior written 
permission from UNBS.  
Requests for permission to reproduce this document should be addressed to  
The Executive Director  
Uganda National Bureau of Standards  
P.O. Box 6329  
Kampala  
Uganda  
Tel: 256 41 4 505 995 
Fax: 256 41 4 286 123  
E-mail: unbs@infocom.co.ug  
Web: www.unbs.go.ug  DUS 883-2:2021  
© UNBS 2021  – All rights reserved  iii 
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ............................  iv 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative references  ................................ ................................ ................................ ............................  1 
3 Terms and definitions  ................................ ................................ ................................ ...........................  1 
4 Classification  ................................ ................................ ................................ ................................ .........  2 
5 Requirements  ................................ ................................ ................................ ................................ .........  2 
5.1 General  ................................ ................................ ................................ ................................ ...................  2 
5.2 Materials  ................................ ................................ ................................ ................................ .................  2 
5.3 Performance requirements  ................................ ................................ ................................ ...................  2 
5.3.1  Water tightness  ................................ ................................ ................................ ................................ ...... 2 
5.3.2  Tensile properties  ................................ ................................ ................................ ................................ .. 3 
5.4 Dimensions  ................................ ................................ ................................ ................................ ............  3 
5.5 Sterility  ................................ ................................ ................................ ................................ ...................  5 
6 Sampling and selection of test pieces  ................................ ................................ ................................  6 
6.1 Sampling  ................................ ................................ ................................ ................................ ................  6 
6.2 Selection of test pieces ................................ ................................ ................................ .........................  6 
7 Packaging  ................................ ................................ ................................ ................................ ...............  6 
8 Labelling  ................................ ................................ ................................ ................................ .................  7 
8.1 General  ................................ ................................ ................................ ................................ ...................  7 
8.2 Unit package  ................................ ................................ ................................ ................................ ..........  7 
8.2.1  Sterile package  ................................ ................................ ................................ ................................ ...... 7 
8.2.2  Non-sterile package  ................................ ................................ ................................ ..............................  7 
8.3 Multi -unit package  ................................ ................................ ................................ ................................ . 8 
Annex  A (normative)  Test for water tightness ................................ ................................ ................................  9 
A.1 Apparatus  ................................ ................................ ................................ ................................ ...............  9 
A.2 Procedure  ................................ ................................ ................................ ................................ .............  10 
Bibliography  ................................ ................................ ................................ ................................ ......................  11 
 DUS 883-2: 2021  
iv © UNBS 2021  – All rights reserved  
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Tourism, Trad e and 
Industry established under Cap 327 , of the Laws of Uganda.  UNBS is mandated to co -ordinate the 
elaboration of standards and is  
(a) a member of International Organisation for Standardisation (ISO) and  
(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT/SPS Agreements of the World Trade Organisation (WTO).  
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberat e on standards in a given field or area and consists of representatives of 
consumers, traders, academicians, manufacturers, government and other stakeholders.  
Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders a nd the 
general public for comments. The committee reviews the comments before recommending the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council.  
 
The committee responsible for this document is Technical Com mittee UNBS/TC 307, Medical devices  and 
equipment .  
This part of WDUS 883 cancels and replace s US 883 -2:2011, which has been technically revised.  
WDUS 883  consists of the following parts, under the  general title  Single -use medical examination gloves  — 
Spec ification  
 Part 1: Specification for gloves made from rubber latex or rubber solution  
 Part 2: Specification for gloves made from poly (vinyl chloride)  
 DRAFT UGANDA STANDARD  DUS 883-2: 2021  
 
© UNBS 2021 – All rights reserved  1 
 Single -use medical examination gloves — Part 2: Specification 
for gloves made from poly (vinyl chloride)  
WARNING — Persons using this Uganda Standard should be familiar with normal laboratory 
practices. This standard does not purport to address all of the safety problems, if any, associated with 
its use. It is the responsibility of the user to establish appr opriate safety and health practices and to 
ensure compliance with any regulatory conditions.  
1 Scope  
This part of  DUS 883, specifies requirements and test methods for packaged sterile, or bulked non -sterile, 
poly (vinyl chloride) gloves intended for use i n medical examinations, and diagnostic or therapeutic 
procedures, to protect the patient and the user from cross -contamination. It also covers poly (vinyl chloride) 
gloves intended for use in handling contaminated medical materials.  
This standard is intend ed as a reference for the performance and safety of poly (vinyl chloride) examination 
gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent 
handling, packaging and storage procedures are outside the scope of t his part of Uganda standard.  
2 Normative references  
The following referenced documents are indispensable for the application of this document. For dated 
references, only the edition cited applies. For undated references, the latest edition of the reference d 
document (including any amendments) applies.  
ISO 37, Rubber, vulcanized or thermoplastic — Determination of tensile stress -strain properties  
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests   
ISO 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test 
methods  
US ISO 2859 -1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by 
acceptance quality level (AQL) for lot -by-lot inspection   
US ISO 10993 (all parts), Biological evaluation of medical devices   
US ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information 
to be supplied  
3 Terms and definitions  
No terms and definitions are listed in this docum ent. ISO and IEC maintain terminological databases for use in 
standardization at the following addresses: — ISO Online browsing platform: available at 
http://www.iso.org/obp  DUS 883 -2: 202 1 
2 © UNBS 2021  – All rights reserved  
 4 Classification  
Gloves are classified by fi nish as follows:  
a) textured surface over part or all of the glove;  
b) smooth surface;  
c) powdered surface; and  
d) powder -free surface.  
NOTE 1  Powdered gloves are gloves where a powder has been added as a part of the manufacturing process, 
generally to facilitate  donning. Powder -free gloves are gloves which have been manufactured without the deliberate 
addition of powdered materials to facilitate donning.  
NOTE 2  The cuff termination of the glove may be cut or in the form of a rolled rim.  
5 Requirements  
5.1 Genera l 
Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer shall 
make available to the purchaser, on request, data to support compliance with these requirements  
5.2 Materials  
Gloves shall be manufactured from pl asticized poly (vinyl chloride). To facilitate donning the gloves, any 
surface treatment, lubricant, powder or polymer coating may be used.  
Any pigment, surface treatment, lubricant, or powder used shall be non -toxic and shall be disclosed on 
request. It is essential that substances used for surface treatment, which are capable of being transferred, are 
bio-absorbable.  
Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer shall 
make available, on request, dat a to support compliance with these requirements.  
NOTE  Limits of extractable plasticizers, residual chemicals and residual powder in gloves may be specified in future 
editions of this part of Uganda standard, subject to the availability of relevant ISO sta ndard test methods.  
5.3 Performance requirements  
5.3.1  Water tightness  
When gloves are tested for water tightness as described in Annex A, the sample size and allowable number of 
non-conforming (leaking) gloves in the sample shall be determined in accorda nce with the inspection level and 
AQL given in Table 1.  
Table 1 — Inspection levels and AQLs  
Characteristics  Inspection level  AQL  
Physical dimensions (width, 
length, thickness)  S-2 4.0 
Water tightness  G-1 2.5 
Force and elongation at break  S-2 4.0 DUS 883-2: 2021  
© UNBS 2021  – All rights reserved  3 
 5.3.2 Tensile properties  
5.3.2.1  General  
Tensile properties shall be measured in accordance with ISO 37, taking three pieces from each glove and 
using the median value as the test result. Test pieces shall be taken from the back, palm and terminal palmer 
surface of the middle finger of the gloves .  
5.3.2.2  Force at break and elongation at break before accelerated ageing  
When determined in accordance with the method specified in ISO 37, using type 2 dumb -bell test pieces, the 
force at break and elongation at  break shall comply with the requirements given in Table 2, using the 
inspection level and AQL given in Table 1.  
5.3.2.3  Force at break and elongation at  break after accelerated ageing  
Accelerated ageing shall be conducted in accordance with the method spe cified in ISO 188. Test pieces can 
be prepared either by ageing the gloves at 70 °C ± 2 °C for 168 h ± 2 h and cutting the test pieces from the 
aged gloves, or by cutting the test pieces from un -aged gloves and ageing the test pieces at 70 °C ± 2 °C for 
168 h ± 2 h. Tensile testing is then conducted as described in 5.3.2.2. The results shall comply with the 
requirements given in Table 2, using the inspection level and AQL given in Table 1 . 
Table 2 — Tensile properties  
Property  Requirement  
Minimum force at break before accelerated ageing, N  7.0  
Minimum elongation at break before accelerated ageing, %  350  
Minimum force at break after accelerated ageing, N  7.0  
Minimum elongation at break after accelerated ageing, %  350  
 
5.4 Dimensions  
When measured  at the points shown in Figure 1, gloves shall comply with the dimensions for palm width and 
length given in Table 3, using the inspection level and AQL given in  table 1   DUS 883 -2: 202 1 
4 © UNBS 2021  – All rights reserved  
 
 
Key 
l length  
w width  
Figure 1 — Measurement points for the width and length of the glove  
Table 3 — Dimensions and tolerances  
Size code  Width 
(dimensions 
w, Figure 1),  
mm  Width (small, 
medium or 
large),  
mm  Width by 
descriptive 
size 
(dimensions 
w, Figure 1),  
mm  Minimum 
length 
(dimension l, 
Figure 1),  
mm  Minimum 
thickness (at 
the locations 
shown in 
Figure 2),  
mm  Maximum 
thickness (at 
the 
approximate 
centre of the 
palm),  
mm  
6 and below  ≤ 82  Extra small  
(X-S)  ≤80  220  
Smooth area: 
0.08  
Textured area: 
0.11  Smooth area: 
0.22  
Textured area: 
0.23  6 ½  83 ± _5  Small (S)  80 ± 10  220  
7  89 ± _5  Medium (M)  95 ± _10  230  
7 ½  95 ± 5  230  
8  102 ± _6  Large (L)  110 ± _10  230  
8 ½  109 ± _6  230 
9 and above  ≥ 110  Extra large  
(X-L)  ≥ 110  230  
The measurement of length shall be the shortest distan ce between the tip of the second finger and the cuff 
termination.  DUS 883-2: 2021  
© UNBS 2021  – All rights reserved  5 
 The length measurement may be taken by hanging the glove on a suitable mandrel with a tip radius of 5 mm.  
The measurement of width shall be at the midpoint between the base of the index fi nger and the base of the 
thumb. The width measurement shall be made with the glove placed on a flat surface.  
The thickness of the double wall of an intact glove shall be measured in accordance with ISO 23529, with a 
pressure on the foot of 22 kPa —5 kPa, at each of the locations shown in Figure 2: at a point 13 mm —3 mm 
from the extreme tip of the second finger and at the approximate centre of the palm. The single -wall thickness 
at each point shall be reported as half the measured double -wall thickness and  shall comply with the 
dimensions given in Table 2, using the inspection level and AQL given in Table 1.  
If visual inspection indicates the presence of thin spots, then single -wall thickness measurements shall be 
made in such areas. The thickness at the s mooth area and textured area of a single wall when measured as 
described in this subclause shall not be less than 0.08 mm and 0.11 mm, respectively.  
The thickness of the cuff termination, measured in accordance with ISO 23529, should preferably not exceed  
2.50 mm.  
NOTE  The distance 48 mm 9 mm locates the approximate centre of the palm for different glove sizes.  
 
NOTE The distance 48 mm 9 mm locates the approximate centre of the palm for different glove sizes.  
Figure 2 — Measurement points for the thickness of the glove  
5.5 Sterility  
If gloves are sterilized, the nature of the sterilization process shall be disclosed.  DUS 883 -2: 202 1 
6 © UNBS 2021  – All rights reserved  
 6 Sampli ng and selection of test pieces  
6.1 Sampling  
For reference purposes, gloves  shall be sampled and inspected in accordance with US ISO 2859 -1. The 
inspection levels and acceptance quality levels (AQLs) shall conform to those specified in Table 1 for the 
characteristics listed.  
When a lot size cannot be determined, a lot of 35001 to 150000 shall be assumed.  
6.2 Selection of test pieces  
Where test pieces are required, they shall be taken from the back, palm and tip (Figure 3) of the gloves.  
 
Figure 3 – Approximate location of the palm and finger tip  
7 Packaging  
If gloves are sterilized, they shall be packed individually or in pairs.  DUS 883-2: 2021  
© UNBS 2021  – All rights reserved  7 
 8 Labelling  
8.1 General  
Marking shal l include a reference to this part of Uganda standard or appropriate international standards and 
appropriate international symbols taken from US ISO 15223 may be used for labelling .  
The language used for marking shall be as agreed upon between the interes ted parties.  
8.2 Unit package  
8.2.1 Sterile package  
The wrapping for each unit package of an individual glove or pair of gloves shall be clearly marked with the 
following:  
a) the name or trademark of the manufacturer or supplier;  
b) physical address of manufa cturer;  
c) the material used;  
d) the words "TEXTURED" or "SMOOTH", "PRE -POWDERED" or "POWDER -FREE", or words to that 
effect for the appropriate glove finish;  
e) the size;  
f) in the case of gloves that have been treated with any surface -dusting material, a warning no te to the 
effect that surface powder should be aseptically removed prior to use;  
g) the manufacturer's identifying lot number;  
h) the words "DATE OF MANUFACTURE" or words to that effect, and the year in four digits and month 
of manufacture;  
i) the EXPIRY DATE and c ondition of storage.  
j) the words "STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED";  
k) the words "FOR SINGLE USE" or words to that effect;  
l) the words "EXAMINATION GLOVE" (or “EXAMINATION GLOVES”); and  
m) the words "Product contains plasticizers (the nature of the plasticizers shall be disclosed) that may be 
harmful to users".  
8.2.2 Non-sterile package  
The package shall be clearly marked with the following:  
a) the name or trademark of the manufacturer or supplier;  
b) Physical address of manufacturer;  
c) the material used;  DUS 883 -2: 202 1 
8 © UNBS 2021  – All rights reserved  
 d) the words "TEXTURED", or "SMOOTH", "PRE -POWDERED" or "POWDER -FREE" or words to that effect 
for the appropriate glove finish;  
e) the size;  
f) the manufacturer's identifying lot number;  
g) the words "FOR SINGLE USE" or words to that effect;  
h) the words "NON -STERILE";  
i) the words "EXAMINATION GLOVE" (or “EXAMINATION GLOVES”)  
j) the words "DATE OF MANUFACTURE" or words to that effect, and the year in four digits and month of 
manufacture;  
k) the DATE OF EXPIRY and condition of storage; and  
l) the words "Product contains plasticiz ers (the nature of the plasticizers shall be disclosed) that may be 
harmful to users".  
8.3 Multi -unit package  
A multi -unit package is one containing a predetermined number of gloves (in unit packs or unpackaged) of the 
same glove size, intended to facilita te safe transport and storage. Multi -unit packages shall be marked in 
accordance with 8.2.1 or 8.2.2, with the approximate number of gloves and with the addition of instructions for 
storage.  DUS 883-2: 2021  
© UNBS 2021  – All rights reserved  9 
 Annex  A 
(normative)  
 
Test for water tightness  
A.1 Apparatus  
A.1.1 Circular hollow mandrel, of minimum external diameter 60 mm and adequate length to hold the glove 
and with the glove attached, to accommodate 1000 cm3 of water. An example is given in Figure A.1.   
NOTE — A transparent circular hollow mandrel would be adv antageous  
 
Key 
1 hook  
2 cylinder  
3 score line on inside surface of wall  
Figure A.1 — Mandrel  
A.1.2  Holding device, deigned to hold the glove in the vertical position filled with water. An example is given 
in Figure A.2.  
DUS 883 -2: 202 1 
10 © UNBS 2021  – All rights reserved  
  
Figure A.2 — Holding device  
A.1.3  Graduated cylinder, of capacity at least 1000 cm3, or other dispensing apparatus capable of delivering 
1000 cm3 at a time.  
A.2 Procedure  
A.2.1  Attach the glove to the circular hollow mandrel by a suita ble device, e.g. an O -ring, so that the glove 
does not extend more than 40 mm over the mandrel.  
A.2.2  Introduce 1000 cm3 ± 50 cm3 of water, at a maximum temperature of 36 °C, into the device. Remove 
water that has inadvertently splashed onto the glove. If the water does not rise to within 40 mm of the cuff end, 
the glove should be raised to ensure that the whole of the glove, excluding the part 40 mm from the cuff end, 
is tested. Note any leaks that are immediately evident. If the glove does not leak immedi ately, make a second 
observation for leaks 2 min to 4 min after pouring water into the glove. Disregard leakage within 40 mm of the 
cuff end. To assist observation, the water may be coloured with a water -soluble dye . 
DUS 883-2: 2021  
© UNBS 2021  – All rights reserved  11 
 Bibliography  
[1] ISO 11193 -2:2006,  Single-use medical examination gloves — Part 2: Specification for gloves made 
from poly (vinyl chloride)  
[2] US 883 -2: 2011 , Single -use medical examination gloves — Part 2: Specification for gloves made from 
poly (vinyl chloride)  
 DUS 883-2: 2021  
© UNBS 2021 – All rights reserved  13 
 Certification marking  
Produc ts that conform to Uganda standards may be marked with Uganda National Bureau of Standards 
(UNBS) Certification Mark shown in the figure below.  
The use of the UNBS Certification Mark is governed by the Standards Act, and the Regulations made 
thereunder. T his mark can be used only by those licensed under the certification mark scheme operated by 
the Uganda National Bureau of Standards and in conjunction with the relevant Uganda Standard. The 
presence of this mark on a product or in relation to a product is an assurance that the goods comply with the 
requirements of that standard under a system of supervision, control and testing in accordance with the 
certification mark scheme of the Uganda National Bureau of Standards. UNBS marked products are 
continually c hecked by UNBS for conformity to that standard.  
Further particulars of the terms and conditions of licensing may be obtained from the Director, Uganda 
National Bureau of Standards.  
 
                                                                                                                                                 DUS 883 -2: 2021  
 
ICS 11.140; 83.140.99  
Price based on nn pages  
© UNBS  2021 – All rights reserved   
  