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| | Dental Care Latex Exam Gloves |
| Product Name | DENTAL CARE Non-Sterile Natural Rubber Latex Examination Glove | |
| Product Description | - PolyTex® blend lined stretchable exam glove.
- Ambidextrous natural rubber latex gloves which are soft, flexible, non-toxic, seamless, moisture resistant and which will allow a high degree of tactile sensitivity.
- Powder Free Polymer Coating
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| Reorder Numbers | 6222 Small 6223 Unisize 6224 Large | |
| 510 (K) Number/Date | K960247 July 29, 1996 | |
| 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
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| Materials | - Allotex® enzyme treated 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.
- Synthetic latex blend inner layer compounded with approved additives
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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 piece glove.
- Cuffs will be rolled to form a bead.
- No donning powder added.
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| Watertightness ASTM AQL for Defects | 2.5 | |
| Iodine Test for Starch
| None Detected
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ASTM ELISA
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10 µg / gram of glove
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ASTM Powder Content
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< 15 mg / glove
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| Physical Parameters AQL | 2.5 | |
| Tensile | 14 MPa Unaged, Minimum 14 MPa Aged, Minimum | |
| Ultimate Elongation | 700% Unaged, Minimum 500% Aged, Minimum | |
| Dimensional Parameters AQL | 2.5 | |
| Width By Sizes, mm (width) Tolerance, mm | 72; 88; 103 +/-2 | |
| Length By Sizes, mm (length) Tolerance, mm | 220; 230; 230 -10, +25 | |
| Thickness, Double Film, mm (thickness) Tolerance | 0.23 minimum | |
| Sterility | Non-Sterile | |
| How Supplied | Size: Small, Unisize, Large | |
| Non-Sterile Packaging, Immediate Container Style | Glue, Seal Ends, Arthur Lock; perforated area with cellophane dust sheild of 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, 10SM Labeled | |
| Carton Dimensions,Inches | 9 3/8 x 10 8/5 x 17 11/16 | |
| 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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