# K982453: Non-Sterile E.P. Latex Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Perry
- Decided: Nov 30, 1998 after 138 days
- Product code: LYY (Latex 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.
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 no predicate by number.

## Indications for use
A disposable device intended for medical purpose that is wom on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

Source page: https://510kreport.com/device/K982453
Methodology: https://510kreport.com/methodology