Class Class I

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) (K223559)

K223559 2023-02-09 Abbreviated
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Description

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) by Nephron Pharmaceuticals Corporation, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK223559
Clearance Date2023-02-09
Clearance TypeAbbreviated
Product CodeLZA
Regulation Number880.6250

Categories

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Predicate lineage for K223559

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) (K223559) cites 2 predicate devices and is itself cited by 2 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K213440Powder Free Nitrile Examination Gloves (Blue, Purple-Blue),...Luliang Hongruida Health Protection...2022
K211003SHOWA(R) Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc.2022

Later devices that cite this one as their predicate

Devices that cite K223559
K numberDeviceApplicantYear
K231740MemorialTM GlovesUs Glove Supply2023
K231349Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tes...Nephron Nitrile, LLC2023

Trace the full predicate network for K223559

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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