# K212535: Nitrile Powder Free Blue Examination Gloves, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Mah Sing Healthcare Sdn. Bhd.
- Decided: Dec 4, 2021 after 115 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 K153562 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210369: Powder Free Nitrile Examination Glove, Pastel Glove Sdn Bhd (2021) Summary page 4.

## Indications for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K212535
Methodology: https://510kreport.com/methodology