# K974710: Nitrile Exam Glove, Powder-Free/White and Blue

- Pathway: 510(k) (Traditional)
- Applicant: Sinochem Ningbo Latex Gloves Factory
- Decided: Feb 25, 1998 after 70 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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
- K980802: Nitrile Exam Glove, Powder-Free, Blue (1998), 1 descendant of its own
- K013998: Powder-Free Lavender/Purple Nitrile Exam Gloves (2002), 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/K974710
Methodology: https://510kreport.com/methodology