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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 K892322
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Golden Bonanza Industrial Corp.
# 725 Sec. 4, Yen Hai Rd.
Fu Shing Hsiang
Chang Hwa Hsien, Taiwan,  TW
Applicant Contact HWAN WU
Correspondent
Golden Bonanza Industrial Corp.
# 725 Sec. 4, Yen Hai Rd.
Fu Shing Hsiang
Chang Hwa Hsien, Taiwan,  TW
Correspondent Contact HWAN WU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 04/28/1989
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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