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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 K922358
Device Name STERLING POWDER FREE PATIENT EXAMINATION GLOVES
Applicant
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Applicant Contact SUSHIL K KANWAR
Correspondent
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Correspondent Contact SUSHIL K KANWAR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/19/1992
Decision Date 06/11/1993
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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