Protos – Latex Surgical Gloves Powdered Smooth Palm Textured
No Produk | : | 42000000-AKS-000049590 |
Certification | : | ISO 9001 : 2008 |
Registration | : | KEMENKES RI AKD 11603410258 |
Other Specification | : | Surgical Sterile, Pouch, Anatomic, Micro Textured, Beaded Cuff, Powder |
Glove Specification
Products Numbers
Item | Size | Length | Inches | Palm Width |
---|---|---|---|---|
6 | 280 – 300 mm | 11.6 | 76 +/-6 mm | |
6.5 | 280 – 300 mm | 11.6 | 83 +/- 6 mm | |
7 | 280 – 300 mm | 11.6 | 89 +/- 6 mm | |
7.5 | 280 – 300 mm | 11.6 | 95 +/- 6 mm | |
8 | 280 – 300 mm | 11.6 | 102 +/- 6 mm | |
8.5 | 280 – 300 mm | 11.6 | 108 +/- 6 mm | |
9 | 280 – 300 mm | 11.6 | 114 +/- 6 mm |
Mill Thickness
Item | Finger | Palm | Cuff |
---|---|---|---|
All Sizes | 5.2 mill | 4.8 mill | 4.0 mill |
Tensile Properties
Item | Before Aging | After Aging |
---|---|---|
Tensile Strenght Mpa (Minimum) | 24 | 18 |
Ultimate Elogation % Minimum | 750 | 560 |
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
Intended Use | : | Medical Activities |
Basic Material | : | Natural Rubber Latex |
FDA Status | : |
Class IIa, Medical Device with 510K |
Colour | : | Natural |
Sterilized by |
: |
Ethylene Oxide Gas |
Material Safety Data Identification
Identification
Product Name | : | Protos |
Product | : |
Latex Examination Gloves Powdered Smooth Palm Textured – Sterile |
Case # | : | Not Established |
IATO/IACO | : | Not Established |
Hazard Rating | : | Not Established |
D.O.T Rating | : | Not Established |
Physical Data
Natural Solid Rubber | : | 98.2 % |
Sulfur | : | 0.5 % |
Zinc Oxide | : | 0.5 % |
Titanium Dioxide | : | 0.4 % |
ZEDC | : | 0.25 % |
ZDBC | : | 0.15 % |
Donning | : | N/A |
Fire And Explosion
Stability | : | Stable |
Flash Point | : | N/A |
Extinguishing Media | : | Foam, Carbon Dioxide, Water |
Normal Precautions
Ventilation | : | Not necessary under normal conditions |
Equipment | : | Not necessary |
Spill/Clean up | : | N/A |
Eyes | : | N/A |
Storage | : | No special precautions necessary. Store in a cool dry place at room temperature |