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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K895807
Device Name STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'
Applicant
Safeskin Corp.
1701 Ponce De Leon Blvd.
Coral Gables,  FL  33134
Applicant Contact D BRAVERMAN
Correspondent
Safeskin Corp.
1701 Ponce De Leon Blvd.
Coral Gables,  FL  33134
Correspondent Contact D BRAVERMAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/29/1989
Decision Date 12/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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