# K221185: TC Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Thanh Cong Pharmaceutical and Trading Company Limited
- Decided: Jun 22, 2022 after 58 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
TC Gloves Powder Free Latex Examination Gloves is a 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/K221185
Methodology: https://510kreport.com/methodology