# K212699: Disposable Powder Free Polyethylene Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Mastermax Plastic (Huizhou), Ltd.
- Decided: May 31, 2022 after 279 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: 5 generations back to K000071 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173228: U-MED Powder Free Polyethylene Examination Gloves,Blue Color, Jiangsu U-Med Rubber & Plastic Products Co., Ltd. (2018) Summary page 4.

## Indications for use
Disposable Powder Free Polyethylene Examination Gloves are powder free and non-sterile disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212699
Methodology: https://510kreport.com/methodology