FDA product code · General Hospital
LYZVinyl Patient Examination Glove
Product code LYZ covers Vinyl Patient Examination Glove, a Class I device regulated under 21 CFR 880.6250. FDA has cleared 799 devices in this code, 3 of them in the last 12 months. Median review time across the 799 most recent decisions is 70 days. openFDA lists 7 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 880.6250
- Review panel
- General Hospital
- Clearances
- 799
What is happening in LYZ right now?
LYZ (Vinyl Patient Examination Glove) has two findings, most consequential first. 2 first-time filers in the last 12 months, Viet Phu Trade and Import Export Co., Ltd. and Basic Medical Technology, Inc (K252467, K252505). The code is crowded, scoring 81 of 100 — 413 companies hold a clearance here and 3 arrived in the last 12 months (LYZ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252467, K252505 |
| Crowding | Context | LYZ:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code LYZ cover?
LYZ is FDA's product code for Vinyl Patient Examination Glove, a Class I device regulated under 21 CFR 880.6250.
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.
Source: openFDA device/classification · record LYZ · retrieved
How many devices has FDA cleared in LYZ?
FDA has cleared 799 devices under product code LYZ since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | |
| K252467 | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. | |
| K252505 | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. | |
| K241252 | Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. | |
| K230046 | Vinyl examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Ever Global (Vietnam) Enterprise Corporation | |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Ever Global (Vietnam) Enterprise Corporation | |
| K223008 | Disposable Vinyl Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | |
| K222442 | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) | Anhui Bytech Medical Supplies Co., Ltd. | |
| K220055 | Disposable, vinyl examination gloves, Yellow | Dezhou Hengchang Medical Technology Co., Ltd. |
How long does FDA review take for LYZ?
The median FDA review time for LYZ is 70 days, measured across the 799 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in LYZ?
openFDA lists 7 recall records against product code LYZ. A recall record covers one firm's corrective action and may span many device lots.
Z-2828-2018TerminatedCypress Medical Products, Ltd.
The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.
Z-0741-2017TerminatedCypress Medical Products, Ltd.
A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Z-0295-2013TerminatedGulf South Medical Supply Inc
Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
Z-0679-2012TerminatedCypress Medical Products, Ltd.
The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
Z-0680-2012TerminatedCypress Medical Products, Ltd.
The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
Showing the 5 most recently initiated of 7. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for LYZ?
MAUDE holds 3 adverse-event reports naming product code LYZ.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in LYZ unusual?
LYZ does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
3 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered LYZ in the last year?
2 companies filed in LYZ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Viet Phu Trade and Import Export Co., Ltd. | K252467 | |
| Basic Medical Technology, Inc. | K252505 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in LYZ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in LYZ?
Across the 799 most recent decisions, these applicants filed most often in LYZ.
| Applicant | Recent clearances |
|---|---|
| Shanghai Antares Industries, Inc. | 14 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 13 |
| Ever Light Plastic Products Co., Ltd. | 11 |
| Grand Work Plastic Products Co., Ltd. | 11 |
| Shanghai Palomar Mountain Industries, Inc. | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch LYZ
Get an email the morning anything changes in LYZ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.