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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K052845
Device Name B-CARE POWDERED LATEX EXAMINATION GLOVES
Applicant
B-CARE INDUSTRIES CO., LTD.
13 RED FOX LANE
LITTLETON,  CO  80127
Applicant Contact Kevin Walls
Correspondent
B-CARE INDUSTRIES CO., LTD.
13 RED FOX LANE
LITTLETON,  CO  80127
Correspondent Contact Kevin Walls
Classification Product Code
OPE
Date Received10/07/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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