# K211341: Blue Nitrile Exam Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Surefine Medical Co., Ltd.
- Decided: Jul 29, 2021 after 87 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 K171422 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171422: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color, Ever Global (Vietnam) Enterprise Corp (2018) Summary page 4.

## Most influential descendants
- K212716: Dermoaroma Disposable Nitrile Examination Glove (2021), 0 descendants of its own

## Indications for use
The Blue Nitrile Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211341
Methodology: https://510kreport.com/methodology