Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (K223437)
Description
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) by Hartalega NGC Sdn. Bhd., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223437
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. Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (K223437) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested... | Hartalega NGC Sdn. Bhd. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use wit... | Better Care Plastic Technology Co.,... | 2023 |
Trace the full predicate network for K223437
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.