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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 K895228
Device Name PATIENT EXAMINATION GLOVES
Applicant
Ray Intl. Co.
G-29, Suyog, L.B.S. Marg,
Vikhroli (W)
Bombay,  IN 400083
Applicant Contact ABRAHAM VARGHESE
Correspondent
Ray Intl. Co.
G-29, Suyog, L.B.S. Marg,
Vikhroli (W)
Bombay,  IN 400083
Correspondent Contact ABRAHAM VARGHESE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/15/1989
Decision Date 01/10/1990
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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