# K030529: Legend (Brand) Nitrile Powder-Free Patient Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Jda (Tianjin) Plastic Rubber Co., Ltd.
- Decided: Aug 8, 2003 after 170 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: 1 generation back to K993247 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993247: Nitrile Powder Free Patient Examination Gloves, Jda Intl., Inc. (1999). Our reading of the summary gave K993241, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.

## Indications for use
Nitrile powder-free patient examination glove is a 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/K030529
Methodology: https://510kreport.com/methodology