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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 K893822
Device Name HONYEE VINYL EXAMINATION GLOVES
Applicant
Honyee Enterprise Co.
# 166-20,Riao-Pu-Li,Matou
Chen,
Tainan,  TW
Applicant Contact JACKSON LEE
Correspondent
Honyee Enterprise Co.
# 166-20,Riao-Pu-Li,Matou
Chen,
Tainan,  TW
Correspondent Contact JACKSON LEE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/23/1989
Decision Date 08/22/1989
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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