# K212438: Comfortpro

- Pathway: 510(k) (Abbreviated)
- Applicant: Thai Rubber Industry Company Limited
- Decided: Dec 7, 2021 after 125 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 K141042 (2015). 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)
- K202377: Palm Care Latex Examination Powder Free Gloves, Hi-Care Thai Gloves Co., Ltd. (2020) Summary page 4.

## Indications for use
Comfortpro latex examination powder free gloves is 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/K212438
Methodology: https://510kreport.com/methodology