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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 K892164
Device Name PATIENT EXAMINATION GLOVES (VINYL)
Applicant
King Handy Five Corp.
17, Kungchu Rd., Fanyuan
Ind. District
Changhua,  TW 52804
Applicant Contact J. G WU
Correspondent
King Handy Five Corp.
17, Kungchu Rd., Fanyuan
Ind. District
Changhua,  TW 52804
Correspondent Contact J. G WU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/06/1989
Decision Date 08/23/1989
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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