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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 K902708
Device Name SAFETY FIRST
Applicant
BRIGHT RUBBER INDUSTRIES PRIVATE LTD.
B-80 TO 84,SECTOR 8
NOIDA, GHAZIABAD, U.P.
INDIA,  IN
Applicant Contact BHATTACHARYYA
Correspondent
BRIGHT RUBBER INDUSTRIES PRIVATE LTD.
B-80 TO 84,SECTOR 8
NOIDA, GHAZIABAD, U.P.
INDIA,  IN
Correspondent Contact BHATTACHARYYA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/20/1990
Decision Date 09/05/1990
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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