FINAL DRAFT UGANDA 
STANDARD  
  FDUS 883-2
First Edition
2009-mm-dd
 
 
Reference numbe r
FDUS 883-2: 2009
 © UNBS 2009 
  
Single-use medical examination gloves — Part 2: Specification 
for gloves made from poly (vinyl chloride) 
 FDUS 883-2: 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 883-2:2009 
© 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 883-2: 2009
 
© UNBS 2009 – 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 a ll 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 part of this Final Draft Uganda Standard, FDUS  883, specifies requirements and test methods for 
packaged sterile, or bulked non-sterile, poly(vinyl chloride) 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 poly (vinyl chloride) gloves intended for use in handling contaminated medical materials.  
This standard is intended as a reference for the perform ance and safety of poly (vinyl chloride) examination 
gloves. The safe and proper usage of examination gl oves and sterilization procedures with subsequent 
handling, packaging and storage procedures are out side the scope of this 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 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 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 883-2: 2009 
2 © UNBS 2009 – All rights reserved
 3 Classification 
Gloves are classified by finish 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. 
4 Requirements 
4.1 General  
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 
Gloves shall be manufactured from plasticized poly (v inyl chloride). To facilitate donning the gloves, any 
surface treatment, lubricant, powder or polymer coating may be used. 
Any pigment, surface treatment, lubricant, or pow der used shall be non-toxic and shall be disclosed on 
request. It is essential that substances used for surf ace treatment, which are capabl e of being transferred, are 
bio-absorbable. 
Gloves as supplied to the user shall comply with t he relevant part(s) of ISO 10993. The manufacturer shall 
make available, on request, data 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 t he availability of relevant ISO 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 FDUS 883-2: 2009 
© UNBS 2009 – All rights reserved  3
 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 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 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. 
Table 2 — Tensile properties 
Property Requirement 
Minimum force at break befor e 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 
 
 
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. FDUS 883-2: 2009 
4 © UNBS 2009 – All rights reserved
 
Key 
l length 
w width 
Figure 1 — Measurement points for the width and length of the glove FDUS 883-2: 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 883-2: 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 reference 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 35001 to 150000 shall be assumed. FDUS 883-2: 2009 
© UNBS 2009 – All rights reserved  7
 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 
 
 
5.2 Selection of test pieces 
Where test pieces are required, they shall be taken fr om the back, palm and tip (Figure 3) of the gloves.  
 
 
Figure 3 – Approximate location of the palm and finger tip 
6 Packaging 
If gloves are sterilized, they sha ll be packed individually or in pairs. FDUS 883-2: 2009 
8 © UNBS 2009 – All rights reserved
 7 Marking 
7.1 General 
Marking shall include a reference to this part of U ganda standard or appropriate international standards and 
appropriate international symbols taken from ISO 15223 may be used for labeling. 
The language used for marking shall be as agreed upon between the interested parties. 
7.2 Unit package 
7.2.1 Sterile package 
The wrapping for each unit package of an individual glov e 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 that effect, and the year in four digits and month 
of manufacture; 
h) the EXPIRY DATE and condition of storage.  
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”); and 
l) the words "Product contains plasticizers (the nature  of the plasticizers shall be disclosed) that may be 
harmful to users". 
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; FDUS 883-2: 2009 
© UNBS 2009 – All rights reserved  9
 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 GLO VE" (or “EXAMINATION GLOVES”)  
i) the words "DATE OF MANUFACTURE" or words to that effect, and the year in four digits and month 
of manufacture; 
j) the DATE OF EXPIRY and condition of storage; and 
k) the words "Product contains plasticizers (the nature  of the plasticizers shall be disclosed) that may be 
harmful to users". 
7.3 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 facilitate safe transpor t and storage. Multi-unit packages shall be marked in 
accordance with 7.2.1 or 7.2.2, with the approximate num ber of gloves and with the addition of instructions for 
storage.  
 FDUS 883-2: 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 advantageous. 
A.1.2 Holding device, deigned to hold the glove in the vertical po sition filled with water. An example is 
given in Figure A.2. 
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 
Attach the glove to the circular hollow mandrel by a suit able device, e.g. an O-ring, so that the glove does not 
extend more than 40 mm over the mandrel. 
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 doe s not rise to within 40 mm of the cuff end, the glove 
should be raised to ensure that the whole of the glov e, excluding the part 40 mm from the cuff end, is tested. 
Note any leaks that are immediately 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 FDUS 883-2: 2009 
© UNBS 2009 – All rights reserved  11
  
 
 
 
 
 
Dimensions in millimeters 
Key 
1 hook 
2 cylinder 
Figure A.1 — Mandrel 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 FDUS 883-2: 2009 
12 © UNBS 2009 – All rights reserved
 
Figure A.2 — Holding device 
 
 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