# K203191: LYDUS Nitrile Examination Gloves, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Nathan Trading Co., Ltd.
- Decided: Feb 12, 2021 after 108 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: 3 generations back to K022548 (2002). 3 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192333: Blue Nitrile Examination Gloves Powder Free, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2020) Summary page 5.

## Most influential descendants
- K213859: Stronghold Group Nitrile Examination Glove, Powder Free (2022), 0 descendants of its own
- K212840: Nitrile Gloves (Model: NE01) (2021), 0 descendants of its own
- K212600: Disposable Medical Nitrile Examination Gloves (Non-sterile) (2021), 0 descendants of its own
- K212551: Nitrile Examination Gloves (2021), 0 descendants of its own
- K211708: Disposable Medical Nitrile Gloves (2021), 0 descendants of its own

## Indications for use
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K203191
Methodology: https://510kreport.com/methodology