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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 K921438
Device Name DISPOSABLE LATEX EXAMINATION GLOVES
Applicant
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Applicant Contact KANWAR
Correspondent
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Correspondent Contact KANWAR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/25/1992
Decision Date 06/23/1992
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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