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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 K943839
Device Name STERMED NON-CHLORINATED POWDER FREE GLOVES
Applicant
Steriltx (Usa), Inc.
510 Thornall St.
Suite 100
Edison,  NJ  08837
Applicant Contact RALPH BUSTER
Correspondent
Steriltx (Usa), Inc.
510 Thornall St.
Suite 100
Edison,  NJ  08837
Correspondent Contact RALPH BUSTER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/05/1994
Decision Date 12/19/1994
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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