Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate (K222181)
Description
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate by Iconic Medicare Sdn Bhd, an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222181
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. Iconic Blue Nitrile Glove – Tested for use with Chemotherapy Drugs & Fentanyl Citrate (K222181) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Us... | Better Care Plastic Technology Co.,... | 2022 |
Trace the full predicate network for K222181
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.