# K210369: Powder Free Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Pastel Glove Sdn Bhd
- Decided: May 13, 2021 after 94 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: 1 generation back to K153562 (2016). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153562: Powder Free Blue Nitrile Examination Glove, Vietglove Corporation (2016) Summary page 4.

## Most influential descendants
- K221378: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (2022), 0 descendants of its own
- K212535: Nitrile Powder Free Blue Examination Gloves, Non-Sterile (2021), 0 descendants of its own

## Indications for use
A patient examination 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/K210369
Methodology: https://510kreport.com/methodology