# K203593: Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decided: Mar 19, 2021 after 100 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 K993247 (1999). 3 ancestors in all.
12 later devices descend from it; 11 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181106: Powder Free Nitrile Patient Examination Gloves, Blue Color, Jiangsu Dongxin Medical Technology Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K212924: Nitrile Examination Gloves (2021), 1 descendant of its own
- K223280: Disposible Nitrile Gloves (2023), 0 descendants of its own
- K223004: Disposable Nitrile Examination Gloves (2022), 0 descendants of its own
- K213848: Medical nitrile examination gloves (Model: JL001) (2022), 0 descendants of its own
- K213851: Disposable Medical Nitrile gloves (2022), 0 descendants of its own

## Indications for use
The nitrile examination glove is intended to be worn on the hands of examiner’s to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Source page: https://510kreport.com/device/K203593
Methodology: https://510kreport.com/methodology