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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 K955341
Device Name NIL LATEX POWDERFREE EXAMINATION GLOVES
Applicant
Shangrila Latex Industries Pvt. , Ltd.
Munshi Manor
20 Altamount Rd.
Bombay 400 026,  IN
Applicant Contact SANJAY MUNSHI
Correspondent
Shangrila Latex Industries Pvt. , Ltd.
Munshi Manor
20 Altamount Rd.
Bombay 400 026,  IN
Correspondent Contact SANJAY MUNSHI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/21/1995
Decision Date 04/26/1996
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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