# K192333: Blue Nitrile Examination Gloves Powder Free

- Pathway: 510(k) (Abbreviated)
- Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Decided: Jan 24, 2020 after 150 days
- Product code: LZA (Polymer 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 K022548 (2002). 2 ancestors in all.
43 later devices descend from it; 24 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172930: mCare Powder-free Blue Nitrile Examination Gloves, Mercator Medical (Thailand), Ltd. (2018) Summary page 4.

## Most influential descendants
- K202384: Palm Care Blue Nitrile Examination Gloves Powder Free (2020), 8 descendants of its own
- K203191: LYDUS Nitrile Examination Gloves, Powder Free (2021), 6 descendants of its own
- K211515: Nitrile Examination Gloves (2021), 2 descendants of its own
- K221169: JR MEDIC Nitrile Examination Gloves Powder Free- Black (2022), 1 descendant of its own
- K213739: Nitrile Examination Gloves (2022), 1 descendant of its own

## Indications for use
Blue Nitrile Examination Gloves Powder Free 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/K192333
Methodology: https://510kreport.com/methodology