# K213681: Ivory Glove Powder-Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Ivory Gloves Sdn. Bhd.
- Decided: Apr 21, 2022 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.

Source page: https://510kreport.com/device/K213681
Methodology: https://510kreport.com/methodology