# K230633: APOLLO ADVANTAGE Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Dell Corning Corporation
- Decided: Jun 5, 2023 after 90 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: 5 generations back to K022548 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213739: Nitrile Examination Gloves, Hangzhou Runheng Medical Co., Ltd. (2022) Summary page 4.

## Indications for use
APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner’s hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K230633
Methodology: https://510kreport.com/methodology