Product code LYZ: 510(k) clearances and predicates
Product code LYZ covers Disposable Vinyl Examination Gloves. FDA lists 799 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
799 clearances on file under product code LYZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 10 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 so far | 1 |
Recent clearances
Newest LYZ clearances in the FDA index, with applicant and decision date:
- K260860, Powder Free Synthetic Vinyl Exam Gloves (Blue, Black), applicant Basic Medical Technology, Inc., decided 2026-04-07. FDA record
- K252467, Disposable Vinyl Examination Gloves, applicant Viet Phu Trade and Import Export Co., Ltd., decided 2025-10-27. FDA record
- K252505, Powder-Free Vinyl Exam Gloves, clear, applicant Basic Medical Technology, Inc., decided 2025-08-28. FDA record
- K241252, Disposable Vinyl Examination Gloves, applicant Anqing Pukang Medical Technology Co., Ltd., decided 2024-05-20. FDA record
- K230046, Vinyl examination gloves, applicant Guangdong Kingfa Sci. & Tech.Co., Ltd., decided 2023-03-25. FDA record
- K221980, Disposable Powder Free Vinyl Examination Gloves, Beige/Clear, applicant Ever Global (Vietnam) Enterprise Corporation, decided 2023-02-06. FDA record
- K220992, Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple, applicant Ever Global (Vietnam) Enterprise Corporation, decided 2022-10-19. FDA record
- K223008, Disposable Vinyl Examination Gloves, applicant Jiangxi Handspro Products Solutions Co., Ltd., decided 2022-10-08. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Powder Free Synthetic Vinyl Exam Gloves (Blue, Black), Powder-Free Vinyl Exam Gloves, clear. Watch new LYZ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LYZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LYZ clearances include Disposable Vinyl Examination Gloves.
How many 510(k) clearances use product code LYZ?
799 at the time this page was generated, from openFDA records.
How do I find a predicate device under LYZ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LYZ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.