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| | Entrust Latex Exam Gloves Powder Free Premium Gloves |
| Product Name | ENTRUST POWDER FREE Non-Sterile Natural Rubber Latex Examination Glove | |
| Product Description | - Ambidextrous, chlorinated, natural rubber latex powder free glove.
- This glove has passed the modified Draize test on 300 human subjects.
- Contains less than 50 mcg of total extractable protein per gram.
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| Reorder Numbers | 6602 Small 6603 Medium 6604 Large | |
| 510 (K) Number/Date | K974065 January 6, 1998 | |
| Standards Conformance | - ASTM D3578 Standard Specifications for Rubber Examination Gloves
- ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
- FDA Modified Draize Test on 300 Human Subjects
- ASTM D5712 Standard Test Method for Analysis of Protein in Natural Rubber and its Products
- ASTM D6124 Residual Powder Test
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| Materials | - Natural Rubber Latex and compounding materials. The chlorinated material 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 latex rubber mixture. The retained latex will be a one-peice glove.
- Outside of glove will have minimum chlorination to enhance grip.
- Dipped gloves will be chlorinated sufficiently for donning.
- Cuffs will be rolled to form a bead.
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| Watertightness ASTM AQL for Defects | 2.5 | |
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ASTM Powder Content
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< 2mg / glove
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| 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 650% 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 all sizes minimum | |
| Thickness, Double Film,mm (thickness) Tolerance | 10 MIL minimum | |
| Sterility | Non-Sterile | |
| How Supplied | Size: Small, Medium, Large | |
| Non-Sterile Packaging, Immediate Container Style | Varnished, virgin kraft, perforated dispenser opening on top of box | |
| 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 | 260 kPa | |
| 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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