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FDA 510(k) Application Details - K221980
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K221980
Device Name
Vinyl Patient Examination Glove
Applicant
Ever Global (Vietnam) Enterprise Corporation
Long Thanh Industrial Zone
Taman Village 810000 VN
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Contact
Jerry Lin
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
07/05/2022
Decision Date
02/06/2023
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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