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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 K103198
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
YOUNGSHENGPLASTIC CO., LTD
NEW INDUSTRIAL PARK
XINCIANGCITY,  CN 453003
Applicant Contact WU WEI
Correspondent
YOUNGSHENGPLASTIC CO., LTD
NEW INDUSTRIAL PARK
XINCIANGCITY,  CN 453003
Correspondent Contact WU WEI
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/29/2010
Decision Date 12/20/2010
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
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