FINAL DRAFT UGANDA 
STANDARD  
  FDUS 883-1
First Edition
2009-mm-dd
 
 
Reference numbe r
FDUS 883-1: 2009
 © UNBS 2009 
  
Single-use medical examination gloves — Part 1: Specification 
for gloves made from rubber latex or rubber solution 
 FDUS 883-1: 2009 
ii © UNBS 2009 – 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 2009  
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, in cluding 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: 256 414 505 995 
Fax: 256 414 286 123 
E-mail: unbs@infocom.co.ug
Web: www.unbs.go.ug  
 FDUS 883-1: 2009 
© UNBS 2009 – All rights reserved  iii
 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 Standardisation (ISO) and  
(b) a contact point for the WHO/FAO Codex A limentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT/SPS Agr eements of the World Trade Organisation (WTO). 
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberate on standards in a gi ven field or area and consists of representatives of 
consumers, traders, academician s, manufacturers, governme nt and other stakeholders. 
Draft Uganda Standards adopted by the Technical Committ ee 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 Council.  
Committee membership 
The following organisations were represented on the Technical Committee for Medical devices standards, UNBS/TC 14, in the development of this standard: 
• Government Analytical Laboratory 
• Joint Medical Stores (JMS) 
• Makerere University School of Publics Health (MUSPH) 
• Meridian Techsystem (MTS) 
• Ministry Of Health (MOH) 
• Mulago Hospital Complex 
• National Drug Authority (NDA) 
• National Medical Stores (NMS) 
• Paragon Hospital 
• Uganda National Bureau of Standards (UNBS) 
 
 FINAL DRAFT UGANDA STANDARD FDUS 883-1:2009
 
© UNBS 2009 – All rights reserved  1
 Single-use medical examination gloves — 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 es tablish appropriate safety and health practices and to 
ensure compliance with any regulatory conditions. 
1 Scope 
This Final Draft Uganda Standard, FDUS 883-1 specifies requirements and methods 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 us er 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 perfor mance and safety of rubber examination gloves. It does 
not cover the safe and proper usage of examination gloves and ster ilization procedures with subsequent 
handling, packaging and storage procedures. 
2 Normative references 
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 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by 
acceptance quality level (AQL) for lot-by-lot inspection  
ISO 10993 (all parts), Biological evaluation of medical devices  
ISO 15223,  Medical devices — Symbols to be used with medical device labels, labelling and information to be 
supplied 
ISO 23529,  Rubber — General procedures for preparing and conditioning test pieces for physical test 
methods 
ASTM D 7103-06, Standard guide for assessment of medical gloves 
ASTM D 3577-09, Standard specification for rubber surgical gloves 
ASTM D 7160-05, Standard practice for determination of expiration date for medical gloves  
ASTM D 3578-05, S tandard specification for rubber examination gloves FDUS 883-1: 2009 
2 © UNBS 2009 – All rights reserved
 3 Classification 
3.1 General 
Gloves are classified by type and fi nish, as given in 3.2 and 3.3. 
3.2 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. 
3.3 Finish 
Four finishes are classified: 
a) textured surface over part or all of the gloves; 
b) smooth surface; 
c) powdered surface; and 
d) powder-free surface. 
NOTE 1 Powdered gloves are gloves where a powder has been applied on the gloves as a part of the manufacturing 
process, generally to facilitate donning. Powder-free gloves are gloves which have been manufactured without the 
deliberate application of powdered mate rials. Powder-free is also referred to as “powderless”, “no powder” or 
“nonpowdered”, or other words to that effect. 
NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim. 
4 Requirements 
4.1 General requirement 
Gloves as supplied to the user shall comply with t he relevant part(s) of ISO 10993. The manufacturer shall 
make available to the purchaser, on request, data to support compliance with these requirements 
4.2 Materials 
4.2.1  Gloves shall be manufactured from compounded natural rubber or nitrile rubber or polychloroprene 
rubber latex, or compounded styrene-butadiene rubber or thermoplastic-elastomer solution, or compounded 
styrene butadiene rubber emulsion.  
4.2.2  Surface treatment, lubricant, powder or polymer coating may be used to facilitate donning the gloves 
subject to compliance with ISO 10993. 
4.2.3  Any pigment used shall be non-toxic.  
4.2.4  Substances used for surface treatment whic h are capable of being transferred should be bio-
absorbable. 
NOTE 1 Other suitable polymeric materials may be includ ed in future editions of this part of Uganda standard. FDUS 883-1: 2009 
© UNBS 2009 – All rights reserved  3
 NOTE 2 It is recognized that some individuals may, over a period of time, become sensitized to a particular rubber 
compound (allergic reaction) and require gloves of an alternative formulation. 
NOTE 3 Limits of extractable proteins, allergenic proteins, residual chemicals, endotoxins and residual powder in 
gloves may be specified in future editions of this part of Ug anda standard, subject to the availability of relevant standard 
test methods. 
4.3 Performance requirements 
4.3.1 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 accordance 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 
 
4.3.2 Tensile properties 
4.3.2.1 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. 
4.3.2.2 Force at break and elongation at break before accelerated ageing 
When determined in accordance with the method specifi ed 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. 
4.3.2.3 Force at break and elongation at break after accelerated ageing 
Accelerated ageing shall be conducted in accordance wi th 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 conducted as described in 4.3.2.2. The results shall comply with the 
requirements given in Table 2, using the inspection level and AQL given in Table 1. FDUS 883-1: 2009 
4 © UNBS 2009 – All rights reserved
 Table 2 — Tensile properties 
Requirement Property 
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 break after accelerated ageing, N 6.0 7.0 
Minimum elongation at break after accelerated ageing, % 500 400 
 
4.4 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. 
 
Figure 1 — Measurement points for the width and length of the glove FDUS 883-1: 2009 
© UNBS 2009 – All rights reserved  5
 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 
6 ½ 83 ±  5 Small (S) 80 ±  10 220 
7 89 ±  5 230 
7 ½ 95 ±  5 Medium (M) 
 95 ±  10 
 230 
8 102 ±  6 230 
8 ½ 109 ±  6 Large (L) 
 110 ±  10 
 230 
9 and 
above ≥ 110 Extra large 
(X-L) ≥ 110 230 Smooth area: 
0.08 
Textured area: 0.11 
 Smooth area: 0.22 
Textured area: 0.23 
 
 
The measurement of length shall be the shortest distanc e between the tip of the second 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 betw een the base of the index finger and the base of the 
thumb. The width measurement shall be made wi th 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 s hown in Figure 2: at a point 13 mm  3 mm 
from the extreme tip of the second fi nger 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 s pots, then single-wall thickness measurements shall be 
made in such areas. The thickness at the smooth ar ea and textured area of a singl e wall when measured as 
described in this subclause shall not be le ss than 0.08 mm and 0.11 mm, respectively. 
The thickness of the cuff termination, measured in ac cordance with ISO 23529, should preferably not exceed 
2.50 mm.  FDUS 883-1: 2009 
6 © UNBS 2009 – All rights reserved
 
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 
4.5 Sterility 
If gloves are sterilized, the nature of the sterilization process shall be disclosed. 
5 Sampling and select ion of test pieces 
5.1 Sampling 
For referee purposes, gloves shall be sampled and inspected in accordance with 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 35 001 to 150 000 shall be assumed. 
5.2 Selection of test pieces 
Where test pieces are required, they shall be taken fr om the palm, back and tips (Figure 3) of the gloves. FDUS 883-1: 2009 
© UNBS 2009 – All rights reserved  7
 
 
Figure 3 – Approximate location of the palm and finger tip 
6 Packaging 
If gloves are sterilized, they shall be packaged individually or in pairs packed in unit packs. 
7 Marking 
7.1 General 
The marking shall include a reference to this part of Uganda standard or appropriate international standards. 
Appropriate international symbols taken from ISO 15223 may be used for labelling in addition to the wording 
given below. 
The language used for marking shall be as agreed upon between the interested parties. FDUS 883-1: 2009 
8 © UNBS 2009 – All rights reserved
 7.2 Unit package 
7.2.1 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) the material used; 
c) the words “TEXTURED” or “SMOOTH”, “PRE-POW DERED” or “POWDER-FREE” or words to that 
effect for the appropriate glove finish; 
d) the size; 
e) in the case 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; 
f) the manufacturer's identifying lot number; 
g) the words “DATE OF MANUFACTURE” or words to t hat effect, and the year in four digits and month 
of manufacture; 
h) the words “STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED”; 
i) the words “FOR SINGLE USE”  or words to that effect; 
j) the words “EXAMINATION GLOVE” (or “EXAMINATION GLOVES”) or “EXAM GLOVE” (or “EXAM 
GLOVES”); 
k) the words “PRODUCT IS MADE FROM NATURAL RUBBER LATEX WHICH MAY CAUSE 
ALLERGIC REACTIONS” or words to that effect for type 1 gloves; and 
l) expiry date and condition of storage. 
7.2.2 Non-sterile package 
The package shall be clearly marked with the following: 
a) the name or trademark of the manufacturer or supplier; 
b) the material used; 
c) the words “TEXTURED” or “SMOOTH”, “PRE-POW DERED” or “POWDER FREE” or words to that 
effect for the appropriate glove finish; 
d) the size; 
e) the manufacturer's identifying lot number; 
f) the words “FOR SINGLE USE”  or words to that effect; 
g) the words “N ON-STERILE”; 
h) the words “EXAMINATION GLOVE” (or “EXAMIN ATION GLOVES”) or “EXAM GLOVE” (or “EXAM 
GLOVES”); FDUS 883-1: 2009 
© UNBS 2009 – All rights reserved  9
 i) the words “DATE OF MANUFACTURE” or words to t hat effect, and the year in four digits and month 
of manufacture; 
j) the words “PRODUCT IS MADE FROM NATURAL RUBBER LATEX WHICH MAY CAUSE 
ALLERGIC REACTIONS” or words to that effect for type 1 gloves; and 
k) expiry date and co ndition of storage. 
7.3 Multi-unit package 
A multi-unit package 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 7.2.1 or 7.2.2, FDUS 883-1: 2009 
10 © UNBS 2009 – 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 1000 cm3 of water. An example is given in Figure A.1. 
NOTE A transparent circular hollow mandrel would be suitable. 
 
Dimensions in millimeters 
 
Key 
a) 1 hook  
b) 2 cylinder  
c) 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 po sition when filled with water. An example 
is given in Figure A.2. 
 FDUS 883-1: 2009 
© UNBS 2009 – All rights reserved  11
 
Figure A.2 — Holding device
 
A.1.3 Graduated cylinder , capacity at least 1000 cm3, or other dispensing apparatus capable of delivering 
1000 cm 3 at a time 
A.2 Procedure 
Attach the glove to the circular hollow mandrel by a suit able device, for example, an  O-ring, so that the glove 
does not extend more than 40 mm over the mandrel. 
Introduce 1 000 cm3 ± 50 cm3 of water at a maximum temperature of 36 °C into the hollow mandrel. Remove 
water that has inadvertently splashed on to the outside of the glove. If t he water does not rise to within 40 mm 
of the cuff end, raise the glove to ens ure that the whole of t he glove, excluding the part 40 mm from the cuff 
end, is tested. Note any leaks immediately evident. If the glove does not leak immediately, make a second 
observation for leaks 2 min to 4 min after pouring the water into the glove. Disregard leakage within 40 mm of 
the cuff end. To assist observation, the wate r may be coloured with a water-soluble dye. 
. FDUS 883-1: 2009 
© UNBS 2009 – All rights reserved  13
 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 gove rned by the Standards Act, and the Regulations made 
thereunder. This mark can be used only by those licens ed under the certification mark scheme operated by 
the Uganda National Bureau of Standards and in co njunction 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 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.  
 
 FDUS 883-1: 2009 
 
ICS nn.nnn.nn 
Price based on 18 pages 
© UNBS 2009 – All rights reserved