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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer patient examination glove
510(k) Number K210496
Device Name Nautilus Nitrile Exam Gloves
Applicant
Nautilus Gloves LLC
767 5th Avenue 15th Floor
Manhattan,  NY  10153
Applicant Contact Mesh Gelman
Correspondent
Nautilus Gloves LLC
767 5th Avenue 15th Floor
Manhattan,  NY  10153
Correspondent Contact Mesh Gelman
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/22/2021
Decision Date 05/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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