Class Class I
Disposible Nitrile Gloves (K223280)
Description
Disposible Nitrile Gloves by Holik Asia Group Co.,Ltd, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK223280
Clearance Date2023-05-08
Clearance TypeTraditional
Product CodeLZA
Regulation Number880.6250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223280
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. Disposible Nitrile Gloves (K223280) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, C... | Stryker Corporation | 2023 |
| K212924 | Nitrile Examination Gloves | Shanxi Nacosa Medical Technology Co... | 2021 |
Trace the full predicate network for K223280
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.