# K053259: Disposable PVC Examination Glove, Powdered and Powder-Free

- Pathway: 510(k) (Traditional)
- Applicant: Practical Protective Plastic Manufactory, Ltd.
- Decided: Jan 18, 2006 after 57 days
- Product code: LYZ (Vinyl 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: 1 generation back to K033229 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033229: (Multiple Labels) Powder-Free Vinyl Examination Gloves, Bernard Technologies, Inc. (2003) Summary page 1.
- K042213: Pre-Powdered Non-Sterile Vinyl Examination Gloves, Shandong Perfect Plastic Co., Ltd. (2004) Summary page 1.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on tie hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Source page: https://510kreport.com/device/K053259
Methodology: https://510kreport.com/methodology