# K033789: Latex Powder-Free Examination Gloves with Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: May 7, 2004 after 155 days
- Product code: LZC (Medical Glove, Specialty)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Cardinal Health's Latex Powder-Free Examination Gloves: named in the summary without a submission number

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Source page: https://510kreport.com/device/K033789
Methodology: https://510kreport.com/methodology