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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 K892701
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Nature'S Farm Products (Thailand) Co., Ltd.
61, Nature'S Farm House, Soi
Ramkhamhaeng 46 Ramkhamhaeng
Huamark Bangkok 10240,  TH
Applicant Contact WILLIAM TAI
Correspondent
Nature'S Farm Products (Thailand) Co., Ltd.
61, Nature'S Farm House, Soi
Ramkhamhaeng 46 Ramkhamhaeng
Huamark Bangkok 10240,  TH
Correspondent Contact WILLIAM TAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 06/06/1989
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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