# K202377: Palm Care Latex Examination Powder Free Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Hi-Care Thai Gloves Co., Ltd.
- Decided: Dec 1, 2020 after 103 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: 2 generations back to K141042 (2015). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192329: Blue Latex Examination Powder Free Gloves, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2019) Summary page 4.

## Most influential descendants
- K211601: Powder Free Latex Examination Glove, Non-Sterile (2022), 0 descendants of its own
- K221185: TC Gloves (2022), 0 descendants of its own
- K213073: Goody Gloves, Wincare, TBG Gloves (2021), 0 descendants of its own
- K212438: Comfortpro (2021), 0 descendants of its own

## Indications for use
Latex Examination Powder Free 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/K202377
Methodology: https://510kreport.com/methodology