# K982218: Nitrile Powder-Free Uniseal Gloves

- Pathway: 510(k) (Traditional)
- Applicant: American Healthcare Products (M) Sdn Bhd
- Decided: Nov 30, 1998 after 159 days
- Product code: LZA (Polymer 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K990186: Synthetic Powder-Free Nitrile Patient Examination Gloves (1999), 0 descendants of its own

## Indications for use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K982218
Methodology: https://510kreport.com/methodology