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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K910879
Device Name PLASTIC (VINYL) EXAMINATION GLOVES
Applicant
Siamount Plastic Corporation , Ltd.
1016 Cathay Trust Bldg. 2nd
Floor Rama 4 Rd.
Bangkok,  TH 10500
Applicant Contact SRIFUENGFUNG
Correspondent
Siamount Plastic Corporation , Ltd.
1016 Cathay Trust Bldg. 2nd
Floor Rama 4 Rd.
Bangkok,  TH 10500
Correspondent Contact SRIFUENGFUNG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/01/1991
Decision Date 04/25/1991
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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