# K252505: Powder-Free Vinyl Exam Gloves, clear

- Pathway: 510(k) (Traditional)
- Applicant: Basic Medical Technology, Inc.
- Decided: Aug 28, 2025 after 20 days
- Product code: LYZ (Vinyl 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: 6 generations back to K091431 (2009). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220469: Disposable Vinyl Examination Glove, Chifeng Huawei Medical Science&Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
Powder-Free Vinyl Exam Gloves, clear is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K252505
Methodology: https://510kreport.com/methodology