MyGuard – Latex Examination Gloves Powder Free Palm 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 |
---|---|---|---|---|
XXS | 240 +/- 2 mm | 9.44 | 65 +/- 5 mm | |
XS | 240 +/- 2 mm | 9.44 | 75 +/- 5 mm | |
S | 240 +/- 2 mm | 9.44 | 85 +/- 5 mm | |
M | 240 +/- 2 mm | 9.44 | 95 +/- 5 mm | |
L | 240 +/- 2 mm | 9.44 | 105 +/- 5 mm | |
XL | 240 +/- 2 mm | 9.44 | 115 +/- 6 mm |
Mill Thickness
Item | Finger | Palm | Cuff |
---|---|---|---|
All Sizes | 4.4 mill | 4.0 mill | 3.2 mill |
Tensile Properties
Item | Before Aging | After Aging |
---|---|---|
Tensile Strenght Mpa (Minimum) | 14 | 14 |
Ultimate Elogation % Minimum | 650 | 500 |
Performance Requirements – AQL
Item | Related Defects | Inspection | |
---|---|---|---|
Level | Inspection | ||
Water Tightness Test | Holes, Pinholes and Lumps | FDA As per 21 CFR Vol. 8 / S-4 Single Normal | 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
Sterility | : | Sterile |
Intended Use | : | Medical Activities |
Basic Material | : | Natural Rubber Latex |
FDA Status | : | Class 1, Medical Device with 510K |
Colour | : | Natural |
Material Safety Data Identification
Identification
Product Name | : | MyGuard |
Product | : |
Latex Examination Gloves Powder Free Palm Textured – Non Sterile |
Case # | : | Not Established |
IATO/IACO | : | Not Established |
Hazard Rating | : | Not Established |
D.O.T Rating | : | Not Established |
Physical Data
Natural Solid Rubber | : | 98.05 % |
Sulfur | : | 0.7 % |
Zinc Oxide | : | 0.5 % |
Titanium Dioxide | : | 0.25 % |
ZEDC | : | 0.30 % |
ZDBC | : | 0.20 % |
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 |
Download MSDS – MyGuard – Latex Examination Gloves Powder Free Palm Textured