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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 K993479
Device Name OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)
Applicant
Omnigrace (Thailand) , Ltd.
641 Moo 5 Kanchanawanit Rd.
Tambon Banpru
Hatyai, Songkhla,  TH 90250
Applicant Contact K.C. CHOONG
Correspondent
Omnigrace (Thailand) , Ltd.
641 Moo 5 Kanchanawanit Rd.
Tambon Banpru
Hatyai, Songkhla,  TH 90250
Correspondent Contact K.C. CHOONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/14/1999
Decision Date 11/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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