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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 K122835
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
Applicant
YUANHANG PLASTIC CO., LTD
RM. 1606 BLDG 1 JIANXIANG YUAN
NO. 209 BEI SI HUAN ZHO
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
YUANHANG PLASTIC CO., LTD
RM. 1606 BLDG 1 JIANXIANG YUAN
NO. 209 BEI SI HUAN ZHO
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/17/2012
Decision Date 12/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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