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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 K892271
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Asma Rubber Products Pvt. , Ltd.
Plot No:39-B Cochin Export
Processing Zone, Thrikkakara
Kerala, India - 682 030,  IN
Applicant Contact C.Y.A RAHIM
Correspondent
Asma Rubber Products Pvt. , Ltd.
Plot No:39-B Cochin Export
Processing Zone, Thrikkakara
Kerala, India - 682 030,  IN
Correspondent Contact C.Y.A RAHIM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/05/1989
Decision Date 07/14/1989
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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