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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 K923862
Device Name LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)
Applicant
Siam Sempermed Corp., Ltd.
8-10 Jootee Anusorn Rd.
Hatyai, Songkhla
Thailand,  TH 90110
Applicant Contact CHERDKIATGUMCHAI
Correspondent
Siam Sempermed Corp., Ltd.
8-10 Jootee Anusorn Rd.
Hatyai, Songkhla
Thailand,  TH 90110
Correspondent Contact CHERDKIATGUMCHAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/03/1992
Decision Date 02/10/1993
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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