# K192329: Blue Latex Examination Powder Free Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Decided: Nov 25, 2019 after 90 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: 1 generation back to K141042 (2015). 1 ancestor in all.
10 later devices descend from it; 6 cite 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)
- K141042: Mcare PF Powder Free Latex Examination High Risk Gloves, Mercator Medical (Thailand), Ltd. (2015) Summary page 4.

## Most influential descendants
- 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
- K221185: TC Gloves (2022), 0 descendants of its own

## Indications for use
Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K192329
Methodology: https://510kreport.com/methodology