
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) |
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# | 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.