# K213448: Powder Free Nitrile Gloves

- Pathway: 510(k) (Traditional)
- Applicant: St Future International Limited
- Decided: Jun 6, 2022 after 224 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 K022548 (2002). 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)
- K210366: Blue Nitrile Powder Free Patient Examination Glove, Non Sterile, Onetexx Sdn Bhd (2021) Summary page 4.

## Indications for use
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.

Source page: https://510kreport.com/device/K213448
Methodology: https://510kreport.com/methodology