Single-use sterile rubber surgical gloves

Single-use sterile rubber surgical gloves- (abstract from ISO 10282:2002) 

1 Scope
This international Standard specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded.
2 Classification
2.1 Type
Two types are classified:
a) Type 1: gloves made primarily from natural rubber latex;
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.
2.2 Design
Two designs are classified:
a) gloves with straight fingers;  b) Gloves with fingers curved in the palmar direction.
The glove shall be anatomically correct, with the thumb positioned towards the palmar surface of the index finger rather than lying flat. The fingers and thumb may be straight or curved in the palmar direction.
2.3 Finish
Four finishes are classified:
a) Textured surface over part or all of the glove;  b) Smooth surface
c) Powdered surface;  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.
3 Sampling and selection of test pieces
3.1 Sampling
For reference purposes, gloves shall be sampled and inspected in accordance with ISO 2859-1. The inspection levels and acceptable 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 35001 to 50 000 shall be assumed.
Table 1 – Inspection levels and AQLs 

Characteristic	Inspection  level	AQL
Physical dimensions(width,length, thickness)	S-2	4.0
Watertightness	I	1.5
Force at break and elongation at break(before and after accelerated ageing) and force at 300% elongation (before accelerated agei	S-2	4.0

3.2 Selection of test piece
Where test pieces are required, they shall be taken from the palm or back of gloves.
4 Requirements
4.1 Dimensions
When measured at the points shown in Figure 1, gloves shall comply with the dimensions for palm width and length given in Table2, using the inspection level and AQL given in Table 1.
The measurement of length shall be shortest distance between the tip of the second finger and the cuff termination.
The thickness of the double wall of an intact gloves shall be measured in accordance with ISO 4648, with a pressure on the foot of 22 kPa ±5 kPa, at each of the locations shown in Figure 2: a point 13mm ± 3 mm from the extreme tip of the second finger, the approximate centre of the palm and a point 25±mm ±5 mm from the cuff termination. The single
Note: The thickness of the cuff termination measured in accordance with ISO should preferably not exceed 2.50 mm.
Table 2 – Dimensions and tolerances

Size code	Width	Minimum length	Minimum thickness
5	67±4	250	For all sizes; Smooth area:0.10 Textured area:0.13
5.5	72±4	250
6	77±5	260
6.5	83±5	260
7	89±5	270
7.5	95±5	270
8	102±6	270
8.5	108±6	280
9	114±6	280
9.5	121±6	280

4.2 Watertightness
When gloves are tested for watertightness, 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.
4.3 Tensile properties
4.3.1 General
Tensile properties shall be measured in accordance with ISO 37, taking three 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 gloves.
4.3.2 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, force at 300% elongation and elongation at break shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1.
4.3.3 Force at break and elongation at break after accelerated ageing
Accelerated aging tests shall be conducted in accordance with the method specified in ISO 188. After the test pieces cut from the gloves have been subjected to a temperature of 70℃ ±2 ℃ for 168h ±2 h, the value of the force at break and the elongation at break shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1.
4.3.4 Force required to produce 300% elongation
When determined in accordance with the method specified in ISO 37, using type 2 dumb-bell
test pieces, the force required to produce an elongation of 300% shall comply with the requirements given in Table 3, using the inspection level and AQL given in Table 1.
Table 3 – Tensile properties

Property	Requirements	Requirements
	Type 1 glove	Type 2 glove
Minimum force at break after accelerated aging, N	12.5	9.0
Minimum force at break after accelerated aging, N	700	600
Minimum force at break after accelerated aging, N	2.0	3.0