510(k) · Cleared
ClearedDisposable PVC Examination Glove, Powdered and Powder-Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Practical Protective Plastic Manufactory, Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jan 18, 2006 as substantially equivalent to K033229 (Bernard Technologies, Inc., 2003) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jan 18, 2006
- Review
- 57 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033229 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK033229 (Multiple Labels) Powder-Free Vinyl Examination GlovesBernard Technologies, Inc. · 2003
- This deviceK053259 Disposable PVC Examination Glove, Powdered and Powder-FreePractical Protective Plastic Manufactory, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033229 | (Multiple Labels) Powder-Free Vinyl Examination Gloves | Bernard Technologies, Inc. | 2003 | — |
| 0 (this device) | K053259 | Disposable PVC Examination Glove, Powdered and Powder-Free | Practical Protective Plastic Manufactory, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033229 | (Multiple Labels) Powder-Free Vinyl Examination GlovesSummary page 1…owdei-ed and Powder-free 3. Predieate Device Information (I) Powder-free Vinyl Examination Gloves Bernaid Technologies, hInc. K-number: K033229 (2) Pre-Powdered Non-Sterile Vinyl Examination Glove Shangdong Perfect Plastic Co., Ltd K-n1~umber:… | 2003 |
| * | K042213 | Pre-Powdered Non-Sterile Vinyl Examination GlovesSummary page 1…gies, hInc. K-number: K033229 (2) Pre-Powdered Non-Sterile Vinyl Examination Glove Shangdong Perfect Plastic Co., Ltd K-n1~umber: K0422 13 4. Device Description: Class I powder-free paiient examination glove LYZ, mecets all of thie requirements of A… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purposes that is worn on tie hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053259 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053259: Disposable PVC Examination Glove, Powdered and Powder-Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053259
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026