LYZ
- Product code
- LYZ
- Device name
- Vinyl Patient Examination Glove
- Device class
- Class 1
- 21 CFR
- 21 CFR 880.6250
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 799
FDA classification definition
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260860 | 2026-04-07 | Basic Medical Technology, Inc. | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black | |
| K252467 | 2025-10-27 | Viet Phu Trade and Import Export Co., | Disposable Vinyl Examination Gloves | — |
| K252505 | 2025-08-28 | Basic Medical Technology, Inc. | Powder-Free Vinyl Exam Gloves, clear | |
| K241252 | 2024-05-20 | Anqing Pukang Medical Technology Co., | Disposable Vinyl Examination Gloves |
Official FDA classification page: LYZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).