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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K896675
Device Name STERLING STYLE 90 SURGICAL GLOVES
Applicant
Steril Rubber Sdn. Bhd.
675 Woodside St.
Fergus, Ontario,
Canada N1m 2m4,  CA
Applicant Contact ZAMMIT
Correspondent
Steril Rubber Sdn. Bhd.
675 Woodside St.
Fergus, Ontario,
Canada N1m 2m4,  CA
Correspondent Contact ZAMMIT
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/27/1989
Decision Date 03/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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