# K970216: Nitrile Examination Gloves-Pre Powdered

- Pathway: 510(k) (Traditional)
- Applicant: Influx Pacific Sdn. Bhd.
- Decided: Sep 26, 1997 after 253 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K974710: Nitrile Exam Glove, Powder-Free/White and Blue (1998), 2 descendants of its own
- K980802: Nitrile Exam Glove, Powder-Free, Blue (1998), 1 descendant of its own
- K980677: Nitrile Exam Glove, Powder Free (1998), 1 descendant of its own
- K013998: Powder-Free Lavender/Purple Nitrile Exam Gloves (2002), 0 descendants of its own
- 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/K970216
Methodology: https://510kreport.com/methodology