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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 K896217
Device Name SAS LATEX EXAMINATION GLOVES
Applicant
Sas Rubber Products Co., Ltd.
109 Moo 8, Bangna-Trad Rd.
Km. 2.5, Phakanong, Bangkok
10260, Thailand,  TH
Applicant Contact CHEVANINTAKUL
Correspondent
Sas Rubber Products Co., Ltd.
109 Moo 8, Bangna-Trad Rd.
Km. 2.5, Phakanong, Bangkok
10260, Thailand,  TH
Correspondent Contact CHEVANINTAKUL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/30/1989
Decision Date 11/21/1989
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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