Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-Rated Exam Gloves

Polymer Patient Examination Glove

Nautilus Gloves LLC

The following data is part of a premarket notification filed by Nautilus Gloves Llc with the FDA for Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-rated Exam Gloves.

Pre-market Notification Details

Device IDK210496
510k NumberK210496
Device Name:Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-Rated Exam Gloves
ClassificationPolymer Patient Examination Glove
Applicant Nautilus Gloves LLC 767 5th Avenue 15th Floor Manhattan,  NY  10153
ContactMesh Gelman
CorrespondentMesh Gelman
Nautilus Gloves LLC 767 5th Avenue 15th Floor Manhattan,  NY  10153
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-22
Decision Date2021-05-26

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