510(k) · Cleared
ClearedBlossom Powder Free Latex Examination Gloves with Protein Content Labeling Claim 50 MCGM or Less of Total Water Extracta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mexpo Intl., Inc. · FMC Patient Examination Glove
Cleared on Aug 17, 1999 after a 35-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Aug 17, 1999
- Review
- 35 days
- Class
- Class I
- Product code
- FMC
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 FMC devicesFMC Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMC
FDA has decided no FMC device since 2007.
Median 510(k) review, days · FMC
Too few FMC 510(k)s in any year since 2007 to give a median.
Recalls per year · FMC
No recall names FMC since 2007.
Adverse event reports per year · FMC
1in 2025
MAUDE reports naming product code FMC, 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 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 333 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K992337 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992337: Blossom Powder Free Latex Examination Gloves with Protein Content Labeling Claim 50 MCGM or Less of Total Water Extracta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992337
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026