# K221374: Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.
- Decided: Oct 26, 2022 after 167 days
- Product code: LYY (Latex 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 K981767 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210253: Best Glove-Latex Powder Free Examination Glove, Bestsafe Glove Co., Ltd. (2021) Summary page 5.

## Indications for use
Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K221374
Methodology: https://510kreport.com/methodology