# K252075: Program insite® Powder-Free, Disposable Nitrile Exam Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Program Insite, LLC
- Decided: Oct 17, 2025 after 107 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 K902696 (1990). 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)
- K190159: Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove, Showa Best Glove, Inc. (2019) Summary page 5.

## Indications for use
A powder-free 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/K252075
Methodology: https://510kreport.com/methodology