# K222531: Synthetic Polymer Glove - Polyethylene (Black)

- Pathway: 510(k) (Traditional)
- Applicant: Ur Industry Sdn Bhd
- Decided: Jan 22, 2023 after 153 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K143247 (2015). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210463: Thermoplastic Elastomer (TPE) Hybrid Examination Glove, Xuzhou Full Sun Medical Products, Ltd. (2022) Summary page 4.

## Indications for use
Powder Free Polyethylene Examination Gloves, is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K222531
Methodology: https://510kreport.com/methodology