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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 K893266
Device Name LATEX EXAMINATION GLOVES
Applicant
Yi-Gang Machinery & Engineering Co., Ltd.
6f-5 Crystal Blde # Hsin Yi
Rd Sec. 4
Taipei,  TW 10056
Applicant Contact SHENG-TA KAO
Correspondent
Yi-Gang Machinery & Engineering Co., Ltd.
6f-5 Crystal Blde # Hsin Yi
Rd Sec. 4
Taipei,  TW 10056
Correspondent Contact SHENG-TA KAO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/1989
Decision Date 06/14/1989
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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