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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 K904642
Device Name VINYL EXAMINATION GLOVES(MFG:KAO YING INDUSTRIAL)
Applicant
Predex Co. , Ltd.
8fl. # 222, Sec. 1 Ho Ping
East Rd.
Taipei, Taiwan, R.O.C.,  CN
Applicant Contact MICHAEL LEE
Correspondent
Predex Co. , Ltd.
8fl. # 222, Sec. 1 Ho Ping
East Rd.
Taipei, Taiwan, R.O.C.,  CN
Correspondent Contact MICHAEL LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/11/1990
Decision Date 10/19/1990
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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