# K032444: Nitrile Powder-Free Examination Gloves with Lotion Coating and Use for Chemotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Nov 13, 2003 after 97 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.
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) Nitrile Powder-Free Examination Gloves, Cardinal Health: named in the summary without a submission number

## Most influential descendants
- K102189: Powder Free Nitrle Examination Gloves with Chemotherapy Labeling Claim (2012), 0 descendants of its own

## 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/K032444
Methodology: https://510kreport.com/methodology