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FDA 510(k) Application Details - K190736
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K190736
Device Name
Polymer Patient Examination Glove
Applicant
Ever Growth (Vietnam) Co. Ltd.
Long Khanh Industrial Zone Binhloc Village
Binhloc Village 810000 VN
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Contact
Ming Lee
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2019
Decision Date
12/23/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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