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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 K831632
Device Name MEDICAL RUBBER GLOVES-STERILE-SURGEONS
Applicant
Tagum Rubber Industries, Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Tagum Rubber Industries, Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/20/1983
Decision Date 07/23/1984
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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