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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 K884030
Device Name ERGO II, SURGICAL LATEX GLOVES
Applicant
Ergo Intl., Ent., Inc.
2291 Ne164 St. Bay #
2291
North Miami Beach,  FL  33160
Applicant Contact B ERTEL
Correspondent
Ergo Intl., Ent., Inc.
2291 Ne164 St. Bay #
2291
North Miami Beach,  FL  33160
Correspondent Contact B ERTEL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/23/1988
Decision Date 11/07/1988
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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