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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 K891722
Device Name LATEX EXAM GLOVES (MFG. SHANGHAI MEHECO)
Applicant
Amerimed US Corp.
10-26 County Line Rd.
Somerville,  NJ  08876
Applicant Contact WAYNE KNUPP
Correspondent
Amerimed US Corp.
10-26 County Line Rd.
Somerville,  NJ  08876
Correspondent Contact WAYNE KNUPP
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/21/1989
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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