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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 K040448
Device Name GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
Applicant
Rosner-Mautby Meditrade(Thailand) , Ltd.
199 Moo 11, Tambon Banpru
Hatyai, Songkhla,  TH 90250
Applicant Contact HO WENG FATT
Correspondent
Rosner-Mautby Meditrade(Thailand) , Ltd.
199 Moo 11, Tambon Banpru
Hatyai, Songkhla,  TH 90250
Correspondent Contact HO WENG FATT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/20/2004
Decision Date 03/23/2004
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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