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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 K000421
Device Name BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
Applicant
SSL AMERICAS, INC. (REGENT MEDICAL)
3585 ENGINEERING DR.
NORCROSS,  GA  30092 -9214
Applicant Contact BRADLEY L PUGH
Correspondent
SSL AMERICAS, INC. (REGENT MEDICAL)
3585 ENGINEERING DR.
NORCROSS,  GA  30092 -9214
Correspondent Contact BRADLEY L PUGH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/08/2000
Decision Date 08/14/2000
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
Recalls CDRH Recalls
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