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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 K892305
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Hemipan Trading & Mfg. Co. (P) , Ltd.
479 Bergen Blvd.
Oradell,  NJ  07649
Applicant Contact A. R PATEL
Correspondent
Hemipan Trading & Mfg. Co. (P) , Ltd.
479 Bergen Blvd.
Oradell,  NJ  07649
Correspondent Contact A. R PATEL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/06/1989
Decision Date 05/18/1990
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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