# K212916: Black Nitrile Powder Free Patient Examination Glove, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Rimba Glove Sdn Bhd
- Decided: Mar 24, 2022 after 192 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 K143247 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190942: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color, Ever Growth (Vietnam) Co., Ltd. (2020) Summary page 4.

## 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. These gloves are designed for single use only and should be disposed after use.

Source page: https://510kreport.com/device/K212916
Methodology: https://510kreport.com/methodology