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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 K970794
Device Name LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
Applicant
Siam Sempermed Corp., Ltd.
110 Moo, 8 Kanjanawanid Rd.,
Thambon Patong
Hatyai, Songkhla,  TH 90230
Applicant Contact POONSUK CHERDKIATGUMCHAI
Correspondent
Siam Sempermed Corp., Ltd.
110 Moo, 8 Kanjanawanid Rd.,
Thambon Patong
Hatyai, Songkhla,  TH 90230
Correspondent Contact POONSUK CHERDKIATGUMCHAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/04/1997
Decision Date 05/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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