# K133478: Powder Free Polyethylene Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Hongzan Plastic Technology Co.,Ltd
- Decided: Jun 2, 2014 after 202 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.
No later device cites it as a predicate yet.
0 of 5 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 1.

## Indications for use
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K133478
Methodology: https://510kreport.com/methodology