# K213107: Powder Free Blue Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Novid Ppe Sdn. Bhd.
- Decided: Feb 17, 2022 after 146 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.
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)
- K172930: mCare Powder-free Blue Nitrile Examination Gloves, Mercator Medical (Thailand), Ltd. (2018) Summary page 5.

## 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/K213107
Methodology: https://510kreport.com/methodology