Class Class I
Synthetic Polymer Glove – Polyethylene (Black) (K222531)
Description
Synthetic Polymer Glove - Polyethylene (Black) by Ur Industry Sdn Bhd, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK222531
Clearance Date2023-01-22
Clearance TypeTraditional
Product CodeLZA
Regulation Number880.6250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222531
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. Synthetic Polymer Glove – Polyethylene (Black) (K222531) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Xuzhou Full Sun Medical Products , ... | 2022 |
Trace the full predicate network for K222531
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.