510(k) · Cleared
ClearedPre-Powdered Nitrile Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
P.T. Latexindo Tobaperkasa · LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Cleared on Jan 5, 1998 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 5, 1998
- Review
- 41 days
- Class
- Class II
- Product code
- LZY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZY? 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 LZY device
- #1 K231448 TANDEM Hip Systemscore 6.4 · 10 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LZY devicesLZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LZY
Too few LZY 510(k)s in any year since 2007 to give a median.
Recalls per year · LZY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZY
74in 2025
MAUDE reports naming product code LZY, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 0 | — | 1 | 20 |
| 2010 | 0 | — | 0 | 38 |
| 2011 | 1 | — | 0 | 43 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 97 |
| 2016 | 0 | — | 0 | 76 |
| 2017 | 0 | — | 0 | 72 |
| 2018 | 0 | — | 0 | 67 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 0 | — | 0 | 79 |
| 2021 | 0 | — | 0 | 59 |
| 2022 | 0 | — | 0 | 65 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 1 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974442: Pre-Powdered Nitrile Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974442
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026