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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 K892162
Device Name PATIENT EXAM GLOVES (MFG. BONANZA INDUSTRIAL CORP)
Applicant
Ing Chen Pacific Ent. , Ltd.
1f., # 21, Ln. 163
Kung Jeng Rd.
Taichung, Taiwan R.O.C.,  TW
Applicant Contact SHYAN-YIH CHOU
Correspondent
Ing Chen Pacific Ent. , Ltd.
1f., # 21, Ln. 163
Kung Jeng Rd.
Taichung, Taiwan R.O.C.,  TW
Correspondent Contact SHYAN-YIH CHOU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/05/1989
Decision Date 04/27/1989
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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