# K980149: Powdered Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Masju Sdn. Bhd.
- Decided: Jan 29, 1998 after 13 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.

Source page: https://510kreport.com/device/K980149
Methodology: https://510kreport.com/methodology