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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K990577
Device Name TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
Applicant
Ta Chia Rubber Ind. Corp.
903 Chung Shan Rd., Sec. 2
Ta Chia, Taichung,  TW 437
Applicant Contact CHIN-MING YANG
Correspondent
Ta Chia Rubber Ind. Corp.
903 Chung Shan Rd., Sec. 2
Ta Chia, Taichung,  TW 437
Correspondent Contact CHIN-MING YANG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/23/1999
Decision Date 05/04/1999
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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