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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 K893273
Device Name LATEX EXAMINATION GLOVES
Applicant
Tien Yee Screen Works Co., Ltd.
# 7, Sec. 1, Yan Hai Rd.
Fu Hsing Hsiang, Changhua
Hsien, Taiwan, R.O.C.,  TW
Applicant Contact S. H NIEN
Correspondent
Tien Yee Screen Works Co., Ltd.
# 7, Sec. 1, Yan Hai Rd.
Fu Hsing Hsiang, Changhua
Hsien, Taiwan, R.O.C.,  TW
Correspondent Contact S. H NIEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/1989
Decision Date 01/17/1990
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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