DRAFT UGANDA STANDARD  
  DUS 883 -1 
Second Edition  
2021 -mm-dd 
 
 
 Reference number  
WDUS 883 -1: 2021  
© UNBS 2021   
  
Single -use medical examination gloves — Part 1: Specification 
for gloves made from rubber latex or rubber solution  
 DUS 883 -1: 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 mechan ical, including 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: 2 56 41 4 505 995  
Fax: 256 41 4 286 123  
E-mail: unbs@infocom.co.ug  
Web: www.unbs.go.ug  WDUS 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 
4.1 General  ................................ ................................ ................................ ................................ ...................  2 
4.2 Type  ................................ ................................ ................................ ................................ ........................  2 
4.3 Finish  ................................ ................................ ................................ ................................ ......................  2 
5 Materials  ................................ ................................ ................................ ................................ .................  2 
6 Sampling and selection of test pieces  ................................ ................................ ................................  3 
6.1 Sampling  ................................ ................................ ................................ ................................ ................  3 
6.2 Selection of test pieces ................................ ................................ ................................ .........................  3 
7 Requirements  ................................ ................................ ................................ ................................ .........  3 
7.1 Dimensions  ................................ ................................ ................................ ................................ ............  3 
7.2 Water tightness  ................................ ................................ ................................ ................................ ...... 5 
7.3 Tensile properties  ................................ ................................ ................................ ................................ .. 5 
7.3.1  General  ................................ ................................ ................................ ................................ ...................  5 
7.3.2  Force at break and elongation at break before accelerated ageing  ................................ .................  5 
7.3.3  Force at break and elongation at break after accelerated ageing  ................................ ....................  5 
7.4 Sterility  ................................ ................................ ................................ ................................ ...................  5 
8 Packaging  ................................ ................................ ................................ ................................ ...............  5 
9 Labelling  ................................ ................................ ................................ ................................ .................  6 
9.1 General  ................................ ................................ ................................ ................................ ...................  6 
9.2 Unit package  ................................ ................................ ................................ ................................ ..........  6 
9.2.1  Sterile package  ................................ ................................ ................................ ................................ ...... 6 
9.2.2  Non-sterile package  ................................ ................................ ................................ ..............................  6 
9.3 Multi -unit package  ................................ ................................ ................................ ................................ . 7 
Annex  A (normative)  Test for water tightness ................................ ................................ ................................  8 
A.1 Apparatus  ................................ ................................ ................................ ................................ ...............  8 
A.2 Procedure  ................................ ................................ ................................ ................................ ...............  9 
Bibliography  ................................ ................................ ................................ ................................ ......................  10 
. DUS 883 -1: 2021  
iv © UNBS 2021  – All rights reserved  
 Foreword  
Uganda National Bureau of  Standards (UNBS) is a parastatal under the Ministry of Tourism, Trade 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 Standardi sation (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 Te chnical Committees. A Technical 
Committee is established to deliberate on standards in a given field or area and consists of representatives of 
consumers, traders, academicians, manufacturers, government and other stakeholders.  
Draft Uganda Standards adopt ed by the Technical Committee are widely circulated to stakeholders and 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 C ouncil.  
 
The committee responsible for this document is Technical Committee UNBS/TC 307, Medical devices  and 
equipment .  
This part of WDUS 883  cancels and replaces US 883 -1:2011 , which has been  technically revised.  
WDUS 883  consists of the following parts,  under the  general title  Single -use medical examination gloves  — 
Specification  
 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 -1: 2021  
 
© UNBS 2021 – All rights reserved  1 
 Single -use medical examination glov es — Part 1: Specification 
for gloves made from rubber latex or rubber solution   
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 appropriate safety and health practices and to 
ensure compliance with any regulatory conditions.  
1 Scope  
This Draft Uganda Standard, DUS 883 -1 specifies requirements and me thods of test for packaged sterile, or 
bulked non -sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic 
procedures to protect the patient and the user from cross -contamination. It also covers rubber gloves intended 
for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces 
over all or part of the glove.  
This standard is intended as a reference for the performance and safety of rubber examination gloves. It does 
not cov er the safe and proper usage of examination gloves and sterilization procedures with subsequent 
handling, packaging and storage procedures.  
2 Normative references  
The following referenced documents are indispensable for the application of this document. Fo r dated 
references, only the edition cited applies. For undated references, the latest edition of the referenced 
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 p ieces 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 document.  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 -1: 202 1 
2 © UNBS 2021  – All rights reserved  
 4 Classification  
4.1 General  
Gloves are classified by type and finish, as given in 4.2 and 4 .3.  
4.2 Type  
Two types are classified:  
a) type 1: gloves made primarily from natural rubber latex; and   
b) type 2: gloves made primarily from nitrile rubber latex, polychloroprene rubber latex, styrene -
butadiene rubber solution, styrene -butadiene rubber emulsion or thermoplastic -elastomer solution.  
4.3 Finish  
Four finishes are classified:  
a) textured surface o ver part or all of the gloves;  
b) smooth surface;  
c) powdered surface;  
NOTE 1  Powdered gloves are gloves to which a powder has been applied on the gloves as a part of the manufacturing 
process, generally to facilitate donning.  
Powdered gloves should have a ma ximum powder limit of 10 mg per gl ove. 
d) Powder -free surface.  
NOTE 2  Powder -free gloves are gloves which have been manufactured without the deliberate application of powdered 
materials. Powder -free is also referred to as “powderless”, “no powder” or “non -powd ered”,  or other words to that effect.  
Powder -free gloves have a maximum of 2. 0 mg powder residue limit per glove.  
NOTE 3  The cuff termination of the glove can be cut or in the form of a rolled rim.  
5 Materials  
Gloves shall be manufactured from compounded n atural rubber or nitrile rubber or polychloroprene rubber 
latex, or compounded styrene -butadiene rubber or thermoplastic -elastomer solution, or compounded styrene -
butadiene rubber emulsion. To facilitate donning the gloves, any surface treatment, lubricant , powder or 
polymer coating may be used if it is in accordance with US ISO 10993 (all parts).  
Any pigment used shall be non -toxic. It is essential that substances used for surface treatment which are 
capable of being transferred shall be bio -absorbable.  
Gloves as supplied to the user shall meet the requirements of the relevant part(s) of US ISO 10993. The 
manufacturer shall make available to the purchaser, on request, data to support compliance with these 
requirements.  
NOTE 1  Other suitable polymeric mater ials can be included in future parts of ISO  11193.  
NOTE 2  It is recognized that some individuals can, over a period of time, become sensitized to a particular rubber 
compound (allergic reaction) and require gloves of an alternative formulation.  DUS 883 -1: 2021  
© UNBS 2021  – All rights reserved  3 
 Limits of e xtractable proteins, allergenic proteins, residual chemicals, endotoxins and residual powder in 
gloves may be specified in future editions of this document, subject to the availability of relevant ISO standard 
test methods.  
6 Sampling and selection of test  pieces  
6.1 Sampling  
For referee purposes, gloves shall be sampled and inspected in accordance with US ISO 2859 -1. The 
inspection levels and acceptance quality limits (AQLs) shall conform to those specified in Table 1 for the 
characteristics listed.  
When a  lot size cannot be determined, a lot of 35 001 to 150 000 shall be assumed.  
Table 1 — Inspection levels and AQLs  
Characteristic  Inspection level  AQL  
Physical dimensions (width, length, thickness)  S-2 4.0 
Water tightness  G-I 2.5 
Force at break and elong ation at break (before and after 
accelerated ageing)  S-2 4.0 
Physical dimensions (width, length, thickness)  S-2 4.0 
6.2 Selection of test pieces  
Where test pieces are required, they shall be taken from the palm or back of gloves.  
7 Requirements  
7.1 Dimen sions  
When measured at the points shown in Figure 1 , gloves shall be in accordance with the dimensions for palm 
width and length given in Table 2 , using the inspection level and AQL given in Table 1 . 
The measurement of length shall be the shortest distance  between the tip of the middle finger and the cuff 
termination.  
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 finger  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 e ach of the locations shown in Figure 1 : 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 sh all be in accordance 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 smooth area and textured area of a single wall when measured as 
described in this sub clause shall not be less than 0.08 mm and 0. 11 mm, respectively.  DUS 883 -1: 202 1 
4 © UNBS 2021  – All rights reserved  
 Table 2 — Dimensions and tolerances  
Size code  Width  
corresponding 
to size code  
(dimension w, 
Figure  1) mm  Descriptive 
size Width  
corresponding 
to descriptive  
size 
(dimension w, 
Figure 1), mm  Minimum  
length  
(dimension l, 
Figure 1), mm  thickness  
(at locations  
shown in  
Figure 1), mm  Maximum  
thickness  
(at 
approximate 
centre of 
palm), mm  
6 and below  <82 Extra 
small(X -S) <80 220 Smooth area: 
0.08 
Textured area: 
0.11 Smooth area: 
2.00 
Textured area: 
2.03 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 abo ve >110 Extra 
large(X -L) >110 230 
 
 
Key 
l length  
w width  
Figure 1 — Measurement points for the length, width and thickness of the glove  
NOTE  The distance 48 mm ± 9 mm locates the approximate centre of the palm for different glove sizes.  DUS 883 -1: 2021  
© UNBS 2021  – All rights reserved  5 
 7.2 Water tight ness  
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 accordance with the inspection level 
and AQL given in Table 1 . 
7.3 Tensile  properties  
7.3.1  General  
Tensile properties shall be measured in accordance with ISO 37, taking three type 2 dumb -bell test pieces 
from each glove and using the median value as the test result. Test pieces shall be taken from the palm or 
back of the glove s. 
7.3.2  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 be in accordance with the requ irements given in Table 3 , using 
the inspection level and AQL given in Table 1 . 
7.3.3  Force at break and elongation at break after accelerated ageing  
Accelerated ageing shall be conducted in accordance with the method specified 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 unaged gloves and ageing the test pieces at 70 °C ± 2 °C for 
168 h ± 2 h. Tensile testing is then c onducted as described in 7.3.2 . The results shall be in accordance with 
the requirements given in Table 3 , using the inspection level and AQL given in Table 1 . 
For gloves that are older than 6 months from the date of manufacture or for which the date of ma nufacture is 
unknown, no accelerated aging shall be conducted and the tensile properties need only conform to the “after 
accelerated aging” values in Table 3 . The 6 -month period should begin with the first day of the month 
immediately after the one in whic h the gloves were manufactured.  
Table 3 — Tensile properties  
Property  Requirement  
Type 1 glove  Type 2  glove  
Minimum force at break before accelerated ageing, N  7.0 7.0 
Minimum elongation at break before accelerated ageing, %  650 500 
Minimum force at b reak after accelerated ageing, N  6.0 6.0 
Minimum elongation at break after accelerated ageing, %  500 400 
7.4 Sterility  
If gloves are sterilized, the nature of the sterilization process shall be disclosed . 
8 Packaging  
If gloves are sterilized, they shall be packaged individually or in pairs packed in unit packs.  DUS 883 -1: 202 1 
6 © UNBS 2021  – All rights reserved  
 9 Labelling  
9.1 General  
The marking shall include a reference to this document. Appropriate international symbols taken from US ISO 
15223 -1 and US ISO 15223 -2 may be used for labelling in addi tion to the wording given below.  
The language used for marking shall be as agreed upon between the interested parties.  
9.2 Unit package  
9.2.1  Sterile package  
The wrapping for each unit package of an individual glove or pair of gloves shall be clearly marke d with the 
following:  
a) name or trademark of the manufacturer or supplier;  
b) physical address of the manufacturer  
c) material used;  
d) words “TEXTURED” or “SMOOTH”, “POWDERED” or “POWDER -FREE” or words to that effect for 
the appropriate glove finish;  
e) size; 
f) in the ca se of gloves that have been treated with any surface -dusting material, a warning note 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 words “STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED”;  
j) the words “FOR SINGLE USE” or words to that effect;  
k) the words “EXAMINATION GLOVE” (or “EXAMINATION GLOVES”) or “EXAM GLOVE” (or “EXA M 
GLOVES”);  
l) the words “PRODUCT IS MADE FROM NATURAL RUBBER LATEX WHICH MAY CAUSE 
ALLERGIC REACTIONS” or words t o that effect for type 1 gloves and  
m) expiry date and condition of storage.  
9.2.2  Non-sterile package  
The package shall be clearly marked with th e following:  
a) name or trademark of the manufacturer or supplier;  
b) Physical address of manufacturer;  
c) material used;  DUS 883 -1: 2021  
© UNBS 2021  – All rights reserved  7 
 d) words “TEXTURED” or “SMOOTH”, “POWDERED” or “POWDER -FREE” or words to that effect for 
the appropriate glove finish;  
e) size 
f) manufacturer's identif ying 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”) or “EXAM GLOVE” (or “EXAM 
GLOVES”);  
j) the words “DATE OF MANUFACTURE” or words to that effect, and the year in four digits and month 
of manufacture;  
k) the words “PRODUCT IS MADE FROM NATURAL RUBBER LATEX WHICH MAY CAUSE 
ALLERGIC REACTIONS” or words t o that effect for type 1 gloves and  
l) expiry date and condition of storage.  
9.3 Multi -unit package  
A multi -unit packa ge is one containing a predetermined number of unit packs of the same glove size, intended 
to facilitate safe transport and storage. Multi -unit packages shall be marked in accordance with 9.2.1 or 9.2.2, 
with the approximate number of gloves and with the a ddition of instructions for storage.  DUS 883 -1: 202 1 
8 © UNBS 2021  – All rights reserved  
 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 1 000 cm 3 of water. An example is given in  Figure  A.1. 
NOTE A transparent circular hollow mandrel would be suitable.  
 
Key 
1 hook  
2 cylinder  
3 score line on inside surface of wall  
Figure A.1 — Mandrel  
A.1.2  Holding device , designed to hold the glove in the vertical position when filled with water. An  example 
is given in Figure A.2 . DUS 883 -1: 2021  
© UNBS 2021  – All rights reserved  9 
 
 
Figure A.2 — Holding device  
A.1.3  Graduated cylinder , capacity at least 1 000 cm 3, or other dispensing device capable of delivering1 
000 cm 3 at a time.  
A.2 Procedure  
A.2.1  Attach the glo ve to the circular hollow mandrel by a suitable 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 ha s 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 immediatel y evident. If the glove does not leak immediately, 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 -1: 202 1 
10 © UNBS 2021  – All rights reserved  
 Bibliography  
[1] ISO 11193 -1:2020, Single -use medical examination gloves — Part 1: Specification for gloves made 
from rubber latex or rubber solution  
[2] US 833 -1:2011, Single -use medical examination gloves — Part 1: Specification for gloves made from  
rubber latex or rubber solution  
 DUS 883 -2: 2021  
© UNBS 2021 – All rights reserved  11 
 Certification marking  
Products 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 govern ed by the Standards Act, and the Regulations made 
thereunder. This 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 Natio nal Bureau of Standards. UNBS marked products are 
continually checked 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