FDA product code LYZ: Vinyl Patient Examination Glove
LYZ is the FDA product code for vinyl patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. FDA has cleared 799 510(k) submissions under LYZ, 16 in the last five years, from 419 different applicants. The average 510(k) review took 98 days (median 70); 30 days on average over the last three years. FDA has posted 7 recalls for LYZ devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Vinyl Patient Examination Glove |
| Device class | Class I |
| Regulation | 21 CFR 880.6250 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LYZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 118 |
| 2018 | 10 | 105 |
| 2019 | 4 | 165 |
| 2020 | 4 | 77 |
| 2021 | 30 | 107 |
| 2022 | 10 | 119 |
| 2023 | 2 | 147 |
| 2024 | 1 | 17 |
| 2025 | 2 | 51 |
| 2026 | 1 | 22 |
Compare with all 510(k) review times · Search every LYZ clearance
Top LYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shanghai Antares Industries, Inc. | 14 | 2005-11-22 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 13 | 1995-01-26 |
| Grand Work Plastic Products Co., Ltd. | 11 | 2022-03-31 |
| Ever Light Plastic Products Co., Ltd. | 11 | 2014-12-18 |
| Shanghai Palomar Mountain Industries, Inc. | 10 | 2004-03-17 |
414 more applicants have LYZ clearances. See the full list in Caduvo.
Most recent LYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260860 | Basic Medical Technology, Inc. | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | 2026-04-07 | 22 |
| K252467 | Viet Phu Trade and Import Export Co., Ltd. | Disposable Vinyl Examination Gloves | 2025-10-27 | 82 |
| K252505 | Basic Medical Technology, Inc. | Powder-Free Vinyl Exam Gloves, clear | 2025-08-28 | 20 |
| K241252 | Anqing Pukang Medical Technology Co., Ltd. | Disposable Vinyl Examination Gloves | 2024-05-20 | 17 |
| K230046 | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Vinyl examination gloves | 2023-03-25 | 78 |
Recalls for LYZ devices
7 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LYZ?
LYZ is the FDA product code for vinyl patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.
What device class is LYZ?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYZ?
Across 799 cleared submissions the average was 98 days from receipt to decision (median 70).
Which companies have the most LYZ clearances?
Shanghai Antares Industries, Inc. (14); Bd Becton Dickinson Vacutainer Systems Preanalytic (13); Grand Work Plastic Products Co., Ltd. (11); Ever Light Plastic Products Co., Ltd. (11); Shanghai Palomar Mountain Industries, Inc. (10).
Have LYZ devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2018-07-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LYZ
- Run a recall and safety report across every LYZ manufacturer
- Watch product code LYZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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