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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 K892090
Device Name SINTON LATEX EXAMINATION GLOVE
Applicant
Sinton Latex Chemical Industries Co., Ltd.
5th Floor # 5
Ching Tou E. Rd.
Taipei, Taiwan, R.O.C.,  TW
Applicant Contact KUO-YU YANG
Correspondent
Sinton Latex Chemical Industries Co., Ltd.
5th Floor # 5
Ching Tou E. Rd.
Taipei, Taiwan, R.O.C.,  TW
Correspondent Contact KUO-YU YANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 04/28/1989
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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