# K033229: (Multiple Labels) Powder-Free Vinyl Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Bernard Technologies, Inc.
- Decided: Dec 17, 2003 after 72 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Class II powder-free patient examination glove 80LYZ: named in the summary without a submission number

## Most influential descendants
- K053259: Disposable PVC Examination Glove, Powdered and Powder-Free (2006), 0 descendants of its own

## Indications for use
A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K033229
Methodology: https://510kreport.com/methodology