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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K991845
Device Name PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
Applicant
OMNIGRACE LTD.
641, MOO5 KANCHANAWANIT ROAD
TAMBON BANPRU
HAT YAI, SONGKHLA,  TH 90250
Applicant Contact K.C. CHOONG
Correspondent
OMNIGRACE LTD.
641, MOO5 KANCHANAWANIT ROAD
TAMBON BANPRU
HAT YAI, SONGKHLA,  TH 90250
Correspondent Contact K.C. CHOONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/28/1999
Decision Date 08/05/1999
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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