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FDA 510(k) Application Details - K142771
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K142771
Device Name
Vinyl Patient Examination Glove
Applicant
Xuanhua Metallurgical Industry CO., LTD
Bridge North, Weisan Rd, East Ring Rd, High-Tec District
Zhangjiakou 075000 CN
Other 510(k) Applications for this Company
Contact
Yanlong Dong
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
09/25/2014
Decision Date
12/22/2014
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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