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  Formula One Sterile Latex Exam Gloves
Product Name THC FORMULA ONE®
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.
  • Sterile
Reorder Numbers 6122 Singles Small
6123 Singles Unisize
6124 Singles Large

6132 Pairs Small
6133 Pairs Unisize
6134 Pairs Large 		 
510 (K) Number/Date K893901 June 14, 1989
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
  • ANSI/AAMI/ISO 11135 Sterilization Specification - Ethylene Oxide
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
 USP Absorbable Dusting Powder
<70 mg per 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
-10; +25
Thickness, Double Film,mm
(thickness) Tolerance		 0.23
minimum
Sterility
Sterility Method
Sterility Assurance Level		 Sterile
Ethylene Oxide (ETO)
10 (-6)
How Supplied Size: Small, Unisize, Large
Sterile Packaging,
Inner Wrap		 Bleached crepe kraft paper marked appropriately for orientation. Printed on both sides are the words "unfold to expose flap" and directly beneath this is an arrow pointing upward on one side and downward on the other.
Sterile Packaging,
Outer Wrap		 The Innerwrap (Singles or Pairs) will be placed in a peelable, non-resealable, cold sealed outer package at the same time of packaging. The face of the outer package will be imprinted with the size of glove inside innerwrap and the reorder number. The back of each package will be imprinted with the lot number for traceability.
Sterile Packaging,
Inner Box		 100 packages of singles per inner
50 packages of pairs per inner
Inner Box Strength
Inner Box Dimensions (inch)		 175 lb. test; B Flute corrugated box
8 3/4 x 6 3/4 x 10 3/8 inches
Sterile Packaging,
Outer Carton		 8 inner boxes per carton
Outer Carton Strenth
Outer Carton Dimensions (inch)		 200 lb. test; C Flute box
18 3/8 x 14 3/4 x 22 inches
Immediate Containers per Carton 8 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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