SECTION I : PRODUCT DESCRIPTION
1.1 Type
Latex Surgical Gloves, Powdered, Gamma Sterilized
1.2 Material
Natural High Grade Rubber Latex
1.3 Color
Natural to white and uniform allowing for gradual shift due to thickness variation
1.4 Design and Feature
Anatomical, hand specific, curved fingers and beaded cuff
1.5 Powder
Inside absorbable cornstarch USPXX1
1.6 Storage Condition
- The gloves shall maintain their properties when stored in a dry condition at temperature between 10° to 30° C.
- Avoid direct sunlight.
1.7 Shelf-Life
The gloves shall have shelf-life of 5 years from the date of manufacture with the above storage condition.
1.8 Packing Style
1 pair/pouch, 50pouches/box, 4boxes/carton, 1000cartons/20'GP or 2000cartons/40'GP
1.9 Size Marking
The size of gloves shall be marked in the label
SECTION II : PERFORMANCE REQUIREMENTS
(Sampling Plan - ISO 2859 Single Normal)
#
Characteristics
Inspection Level
Acceptable Quality Level
Reference Standard
2.1 Dimensions
Median of 13 test pieces
EN455-2-00
2.2 Physical Properties
Median of 13 test pieces
EN455-2-00
2.3 Freedom from holes (Barrier)
(1000ml Water Leak Test)

GI
1.5
EN455-1-00
2.4
(i)
(ii)
Visual Defects
Major Visual
Minor Visual
GI
1.5
2.5
In-house practice
2.5 Powder Amount
N=2
N/A
ASTM D3577-01
ASTM D6124-00
2.6 Protein Content
N=3
N/A
ASTM D3577-01
ASTM D5712-95/99
2.7 Mix Size / Mix Glove / Mix Hand
Not Allowed
SECTION III : PERFORMANCE SPECIFICATION
3.1 Dimensions
Property
Size
In-House Standard
Length (mm)
All Sizes
Min 280
Palm Width (mm)
6
6.5
7
7.5
8
8.5
9
77 +/- 5
83 +/- 5
89 +/- 5
95 +/- 5
102 +/- 6
108 +/- 6
115 +/- 5
Thickness (mm)
*single wall
All Sizes
Finger : Min 0.17
Palm : Min 0.14
Cuff : Min 0.11
3.2 Physical Properties
Property
In-House Standard
Before Aging
After Aging
Elongation at break (%)
Min 750
Min 560
Tensile Strength (MPa)
Min 24
Min 18
Stress at 500% Elongation (MPa)
Min 5.5
N/A
Median Force at Break (N)
Min 12
Min 9

3.3 Freedom from Holes (Barrier) (1000ml Water Leak Test)
The sample size and allowable number of non-conforming gloves in the samples shall be determined in accordance to Sampling Plan ISO 2859-1 Single Normal using inspection and acceptable quality level as stated in Section II: Performance Requirements.

3.4 Visual Defects
The sample size and allowable number of non-conforming gloves in the samples for both major and minor defects shall be determined in accordance to Sampling Plan ISO 2859-1 Single Normal using Inspection and acceptable quality level as stated in Section II: Performance Requirements.