Shamrock – Latex Surgical Gloves Powdered Plam Textured
No Produk | : | 42000000-AKS-000049590 |
Certification | : | ISO 9001 : 2008 |
Registration | : | KEMENKES RI AKD 11603410258 |
Class Product | : | Class Ila, Medical Device |
Glove Specification
Products Numbers
Item | Size | Length | Inches | Palm Width |
---|---|---|---|---|
6 | Min. 285 mm | 11.6 | 76 +/-6 mm | |
6.5 | Min. 285 mm | 11.6 | 83 +/- 6 mm | |
7 | Min. 285 mm | 11.6 | 89 +/- 6 mm | |
7.5 | Min. 285 mm | 11.6 | 95 +/- 6 mm | |
8 | Min. 285 mm | 11.6 | 102 +/- 6 mm | |
8.5 | Min. 285 mm | 11.6 | 108 +/- 6 mm | |
9 | Min. 285 mm | 11.6 | 114 +/- 6 mm |
Mill Thickness
Item | Finger | Palm | Cuff |
---|---|---|---|
All Sizes | Min. 0.24 mill | Min. 0.22 mill | Min. 0.17 mill |
Tensile Properties
Item | Before Aging | After Aging |
---|---|---|
Tensile Strenght Mpa (Minimum) | 24 | 18 |
Ultimate Elogation % Minimum | 750 | 560 |
Stress at 500% Elongation (Maximum) |
5.5 |
Performance Requirements – AQL
Item | Related Defects | Inspection | |
---|---|---|---|
Level | Inspection | ||
Water Tightness Test | Holes, Pinholes and Lumps |
FDA As per 21 CFR Vol. 8 |
1.5 |
Physical Dimension | Length, Width, Thickness | S-2 | 4.0 |
Physical Properties | Before and After accelerated aging | S-2 | 4.0 |
Visual Defect | Stains,etc | S-4 | 2.5 |
Specification
Product Brand | : | Shamrock |
Product Name |
: |
Latex Surgical Glove Powdered Palm Textured – Translucent Beadingless |
Sterility |
: |
Sterile |
Sterilized by |
: |
Ethylene Oxide Gas |
Intended Use |
: |
Medical Surgery Purposes |
Basic Material |
: |
Natural Rubber Latex |
Donning Lubricant |
: |
USP Absorbable Dusting Powder |
Color |
: |
Natural |
Orientation |
: |
Anatomic |
Cuffs |
: |
Un Beaded |
Packaging |
: |
|
Inner box Labelling |
: |
As per customer requirement |
Carton Labelling |
: |
As per customer requirement |