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  Formula One Latex Exam Gloves
Product Name THC FORMULA ONE
Non-Sterile Natural Rubber Latex Examination Glove		  
Product Description
  • Ambidextrous natural rubber latex gloves which are soft, flexible, non-toxic, seamless, moisture resistant and which will allow a high degree of tactile sensitivity.
  • Lightly powdered for easy donning.
  • Gloves will have a rolled, beaded cuff.
Reorder Numbers 6102 Small
6103 Unisize
6104 Large		  
510 (K) Number/Date K002719 January 26, 2001
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
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.
  • Polytex inner lining.
  • Emollient treated Absorbable Dusting Powder, USP is a micropulverized modified starch powder.
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.
  • Gloves will be uniformly and adequately powdered on the inside.
Watertightness
ASTM
AQL for Defects		 2.5
ASTM Powder
Content Test
 <70 mg / glove
Protein Content
ASTM ELISA
 <10 µg / gram of glove
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; 86; 103
+/-2
Length By Sizes, mm
(length) Tolerance, mm		 220; 230; 230
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
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 3
Carton Dimensions,Inches 18 1/4 x 10 5/8 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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