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  Powder Free Plus Latex Exam Gloves
Product Name POWDER FREE PLUS
Powder Free Non-Sterile Natural Rubber Latex Examination Glove		  
Product Description
  • Ambidextrous, natural rubber latex non-chlorinated, 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.
Reorder Numbers 6612 Small
6613 Medium
6614 Large		  
510 (K) Number/Date K960225 July 6, 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
  • 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 D6124 Residual Powder Test
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.
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.
  • Polysiloxane will be applied to the inside only to facilitate donning.
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		 220; 230; 230
minimum
Thickness, Double Film,mm
(thickness) Tolerance		 0.23
minimum
Sterility Non-Sterile
How Supplied Size: Small, Medium, 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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