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| | AccuTouch Latex Exam Gloves Powder Free |
| Product Name | ACCUTOUCH Powder Free Non-Sterile Natural Rubber Latex Examination Glove | |
| Product Description | - Ambidextrous, textured natural rubber latex non-chlorinated, powder free glove.
- Contains less than 50 mcg of total water extractable protein per square decimeter of surface area..
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| Reorder Numbers | 6621 X-Small 6622 Small 6623 Medium 6624 Large 6625 X-Large | |
| 510 (K) Number/Date | K992428 August 9, 1999 | |
| Standards Conformance | - ASTM D3578 Standard Specifications for Rubber Examination Gloves
- ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
- Gauge shall be determined according to Federal Test Standard 601, Method 2011
- ASTM D5712 Standard Test Method for Analysis of Protein in Natural Rubber and its Products
- ASTM Draft Residual Powder Test
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| Materials | - Natural Rubber Latex and compounding materials. All will be non toxic, generally non-irritating in the amounts used, and determined to be safe for use in medical gloves.
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| Construction | - The gloves will be formed by dipping hand shaped molds into a liquid rubber mixture. The retained latex will be a one-peice glove.
- Cuffs will be rolled to form a bead.
- Formed glove will be washed to remove residuals.
- A Polymer emulsion will be applied to the inside only to facilitate donning.
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| Watertightness ASTM AQL for Defects | 2.5 | |
| ASTM Powder Content | < 2 mg/ glove | |
| ASTM Lowry | < 50 µg / gram of glove | |
| Physical Parameters AQL | 2.5 | |
| Tensile | 21 MPa Unaged, Minimum 16 MPa Aged, Minimum | |
| Ultimate Elongation | 700% Unaged, Minimum 500% Aged, Minimum | |
| Dimensional Parameters AQL | 2.5 | |
| Width By Sizes, mm (width) Tolerance, mm | 80; 95; 110; +/-10 | |
| Length By Sizes, mm (length) Tolerance, mm | 230 minimum | |
| Thickness, Double Film,mm (thickness) Tolerance | 0.23 minimum | |
| Sterility | Non-Sterile | |
| How Supplied | Size: X-Small, Small, Medium, Large, X-Large | |
| Non-Sterile Packaging, Immediate Container Style | Glue, sealed ends, Arthur Locks; with cellophane window 7 x 4, Double Layered 2.5 Mil Poly | |
| Non-Sterile Packaging, Immediate Container Dimensions (inch) | 5.25 x 3.5 x9; perforation area 6 x 2 on top panel | |
| Non-Sterile Packaging, Immediate Container, Materials | 0.018" board meeting requirements of CFR #176.180 | |
| Gloves per Immediate Container Tolerance (minimum average) | 100 gloves per dispenser box +/- 2% | |
| Packaging, Cartons, Strength | 200# Test Kraft Color, C Flute 4 | |
| Carton Dimensions,Inches | 18 1/8 x 10 5/8 x 17 3/4 | |
| Immediate Containers per Carton | 10 dispenser boxes | |
| Regulatory Conformance, Labeling | - All levels of packaging shall conform to all appropriate government labeling regulations.
- All materials and ingredients used will be in accordance with regulations issued by the US FDA.
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