# K980677: Nitrile Exam Glove, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Yujiang Plastic & Rubber Co., Ltd.
- Decided: Mar 16, 1998 after 24 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
Longest line of descent: 1 generation back to K970216 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970216: Nitrile Examination Gloves-Pre Powdered, Influx Pacific Sdn. Bhd. (1997) Summary page 1.

## Most influential descendants
- K991821: Nitrile Examination Glove, Powdered, Blue (1999), 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.

Source page: https://510kreport.com/device/K980677
Methodology: https://510kreport.com/methodology