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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K905527
Device Name NEEDLESTICK PROTECTIVE GLOVE
Applicant
Medev Corp.
Post Office Box 7155
Hampton,  VA  23666
Applicant Contact STEPHEN L GREEN
Correspondent
Medev Corp.
Post Office Box 7155
Hampton,  VA  23666
Correspondent Contact STEPHEN L GREEN
Regulation Number880.6250
Classification Product Code
LZC  
Date Received12/10/1990
Decision Date 03/22/1991
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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