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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 K942856
Device Name POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Pacificlink Exp.Industries Private , Ltd.
101 Zia Apt.s
264 Belasis Rd.
Bombay Central Maharashtra,  IN 400 008
Applicant Contact A.S.A. PAGARKAR
Correspondent
Pacificlink Exp.Industries Private , Ltd.
101 Zia Apt.s
264 Belasis Rd.
Bombay Central Maharashtra,  IN 400 008
Correspondent Contact A.S.A. PAGARKAR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/16/1994
Decision Date 12/07/1994
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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