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FDA 510(k) Application Details - K210496
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K210496
Device Name
Polymer Patient Examination Glove
Applicant
Nautilus Gloves LLC
767 5th Avenue 15th Floor
Manhattan, NY 10153 US
Other 510(k) Applications for this Company
Contact
Mesh Gelman
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
02/22/2021
Decision Date
05/26/2021
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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