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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 K101358
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
ROOM 1606 BLDG 1 JIANXIANG
YUAN NO 209 BEI SI HAUN ZHO
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD.
ROOM 1606 BLDG 1 JIANXIANG
YUAN NO 209 BEI SI HAUN ZHO
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/14/2010
Decision Date 08/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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