510(k) · Cleared
ClearedPowder-Free-Vinyl Examination Gloves, Color: White
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glormed Intl., Inc. · LYZ Vinyl Patient Examination Glove
Cleared on Jun 6, 2002 as substantially equivalent to K992979 (Shanghai Poseidon Plastic Products Co., Ltd., 2000) and 1 other predicate after a 41-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jun 6, 2002
- Review
- 41 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992979 (2000). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992979 Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves…Shanghai Poseidon Plastic Products Co., Ltd. · 2000
- This deviceK021353 Powder-Free-Vinyl Examination Gloves, Color: WhiteGlormed Intl., Inc. · 2002
- Descendant · cites it directly · 0 of its ownK041945 Powder-Free Blue Vinyl Exam GlovesGlormed Intl., Inc. · 2004
- Descendant · cites it directly · 0 of its ownK031104 Powdered Vinyl Exam Gloves, WhiteGlormed Intl., Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992979 | Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves, Yellow | Shanghai Poseidon Plastic Products Co., Ltd. | 2000 | — |
| 0 (this device) | K021353 | Powder-Free-Vinyl Examination Gloves, Color: White | Glormed Intl., Inc. | 2002 | — |
| +1 | K041945 | Powder-Free Blue Vinyl Exam Gloves | Glormed Intl., Inc. | 2004 | — |
| +1 | K031104 | Powdered Vinyl Exam Gloves, White | Glormed Intl., Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K992979 | Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves, YellowSummary page 1….o~s~ei.d~o~~.~las~t.i.~~ devices manufactured by , Products Company, Ltd. (K992979). 510k) Summary page 2. Test Results (Means and/or Successll Results: This device has met or exce… | 2000 |
| * | K002340 | Vinyl Examination Glove, Powder-Free, Yellow | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021353: Powder-Free-Vinyl Examination Gloves, Color: White.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021353
Report an extraction error
Are you the manufacturer?
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