# K202384: Palm Care Blue Nitrile Examination Gloves Powder Free

- Pathway: 510(k) (Abbreviated)
- Applicant: Hi-Care Thai Gloves Co., Ltd.
- Decided: Dec 2, 2020 after 104 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: 3 generations back to K022548 (2002). 3 ancestors in all.
8 later devices descend from it; 8 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)
- K192333: Blue Nitrile Examination Gloves Powder Free, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2020) Summary page 4.

## Most influential descendants
- K230958: First Glove Blue Nitrile Examination Gloves Powder Free (2023), 0 descendants of its own
- K212629: PP Care Nitrile Examination Gloves (2022), 0 descendants of its own
- K213500: TMG Nitrile Powder Free Examination Glove (2022), 0 descendants of its own
- K213075: Goody Gloves, Wincare, TBG Gloves (2022), 0 descendants of its own
- K211624: USA Gloves Nitrile Powder Free Exam Gloves (2021), 0 descendants of its own

## Indications for use
Blue Nitrile Examination Gloves Powder Free is 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/K202384
Methodology: https://510kreport.com/methodology