| |
Powdered Surgical Gloves
| 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. |
