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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 K892191
Device Name PATIENT EXAMINATION GLOVES (VINYL)
Applicant
Hsing YI Plastics Processing Co, Ltd.
13, Chu Tsun Li
Puh-Tzu Chia-Yi Hsien 61309
Taiwan,  TW
Applicant Contact C. Y WU
Correspondent
Hsing YI Plastics Processing Co, Ltd.
13, Chu Tsun Li
Puh-Tzu Chia-Yi Hsien 61309
Taiwan,  TW
Correspondent Contact C. Y WU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/05/1989
Decision Date 09/08/1989
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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