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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K895642
Device Name LATEX PATIENT EXAMINATION GLOVES
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
Classification Product Code
OPE
Date Received09/19/1989
Decision Date 12/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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