510(k) · Cleared
ClearedLatex Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pt. Haloni Jane · OPE (no longer in FDA’s product-code list)
Cleared on Nov 17, 1994 after a 51-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Nov 17, 1994
- Review
- 51 days
- Product code
- OPE
- 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 OPE? 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.
https://510kreport.com/device/K944778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944778: Latex 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/K944778
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026