# K173228: U-MED Powder Free Polyethylene Examination Gloves,Blue Color

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu U-Med Rubber & Plastic Products Co., Ltd.
- Decided: Feb 20, 2018 after 139 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: 4 generations back to K000071 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113639: C2 Medical Gloves, Amercare, Inc. (2012) Summary page 4.

## Most influential descendants
- K212699: Disposable Powder Free Polyethylene Examination Gloves (2022), 0 descendants of its own

## Indications for use
Powder Free Polyethylene Examination Gloves,Blue Color is a non-sterile 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/K173228
Methodology: https://510kreport.com/methodology