Class Class I

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (K242812)

K242812 2024-10-12 Special
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Description

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) by Nb Medical Company Limited, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK242812
Clearance Date2024-10-12
Clearance TypeSpecial
Product CodeLZA
Regulation Number880.6250

Categories

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Predicate lineage for K242812

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. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) (K242812) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K220343Nitrile Examination GlovesNb Medical Co., Ltd.2022

Trace the full predicate network for K242812

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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