# K213934: Pro Guard Nitrile Powder Free Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Medical Glove Co., Ltd.
- Decided: Aug 6, 2022 after 233 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 K060724 (2006). 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)
- K143131: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Kossan International Sdn Bhd (2015) Summary page 4.

## Indications for use
Pro GuardR Nirile Powder Free Examination Glove is a disposable device Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K213934
Methodology: https://510kreport.com/methodology