# K141042: Mcare PF Powder Free Latex Examination High Risk Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Mercator Medical (Thailand), Ltd.
- Decided: Mar 19, 2015 after 330 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K192329: Blue Latex Examination Powder Free Gloves (2019), 10 descendants of its own
- K202377: Palm Care Latex Examination Powder Free Gloves (2020), 4 descendants of its own
- K250069: Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein (2025), 0 descendants of its own
- K222348: JR Medic (2022), 0 descendants of its own
- K211601: Powder Free Latex Examination Glove, Non-Sterile (2022), 0 descendants of its own

## Indications for use
The mCare Powder Free Latex Examination Blue Glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K141042
Methodology: https://510kreport.com/methodology