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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 K926277
Device Name POWDER FREE LATEX EXAMINATION GLOVES
Applicant
A.P. Rubber Co., Ltd.
26/2 Rajyindee Rd.
Hityai
Songkhla Thailand,  TH
Applicant Contact DUANGPORN EIWWONGCHA
Correspondent
A.P. Rubber Co., Ltd.
26/2 Rajyindee Rd.
Hityai
Songkhla Thailand,  TH
Correspondent Contact DUANGPORN EIWWONGCHA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/14/1992
Decision Date 06/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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