Class Class I

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K222907)

K222907 2023-01-04 Traditional
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Description

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate by Rmkh Glove (Cambodia) Co., Ltd., an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK222907
Clearance Date2023-01-04
Clearance TypeTraditional
Product CodeLZA
Regulation Number880.6250

Categories

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Predicate lineage for K222907

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 Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K222907) 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
K192954Power Free Nitrile Examination Gloves Tested for Use with C...Comfort Rubber Gloves Industries Sd...2020

Trace the full predicate network for K222907

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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