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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 K984094
Device Name VINYL EXAMINATION GLOVES, PREPOWDERED USP
Applicant
Trans Ancient Products Co., Ltd.
# 10-3, Lane 73, Sec. 2
Chung Hua E. Rd.
Tainan,  TW
Applicant Contact JOANNA LEE
Correspondent
Trans Ancient Products Co., Ltd.
# 10-3, Lane 73, Sec. 2
Chung Hua E. Rd.
Tainan,  TW
Correspondent Contact JOANNA LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/16/1998
Decision Date 01/14/1999
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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