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FDA 510(k) Application Details - K142911
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K142911
Device Name
Vinyl Patient Examination Glove
Applicant
HUAILAI ZM PLASTIC PRODUCTS CO., LTD
SANCHENG ECONOMIC DEVELOPMENT ZONE, HUAILAI COUNTY
ZHANGJIAKOU 075400 CN
Other 510(k) Applications for this Company
Contact
ZHUAHAO ZHANG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/06/2014
Decision Date
04/10/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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