510(k) · Cleared
ClearedPolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ineo Tech Sdn Bhd · KGO Surgeon'S Gloves
Cleared on Sep 29, 2023 as substantially equivalent to K192933 (Emerson & Co. Srl, 2021) after an 88-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Sep 29, 2023
- Review
- 88 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K192933 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backK192933 Polyisoprene Powder Free, Black Colour Surgical GlovesEmerson & Co. Srl · 2021
- This deviceK231973 PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical…Ineo Tech Sdn Bhd · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K192933 | Polyisoprene Powder Free, Black Colour Surgical Gloves | Emerson & Co. Srl | 2021 | — |
| 0 (this device) | K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd | 2023 | — |
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 KGO? 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 KGO device
- #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K192933 | Polyisoprene Powder Free, Black Colour Surgical GlovesSummary page 4…mber: 21 CFR 878.4460 Device Class: Class I (general controls) Assigned 510k number K231973 3. Identification of Predicate Devices • 510(k) number K192933 by Emerson & Co. S.r.l is identified as the primary predicate device • 510(k) number K022873 is considered as reference device… | 2021 |
| † | K022873 | Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black) | 2003 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KGO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGO
185in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGO
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGO
21in 2025
MAUDE reports naming product code KGO, 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 | 10 | 113 | 0 | 13 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 3 | 48 | 15 | 14 |
| 2010 | 6 | 87 | 1 | 16 |
| 2011 | 11 | 90 | 0 | 14 |
| 2012 | 7 | 133 | 0 | 14 |
| 2013 | 6 | 184 | 0 | 41 |
| 2014 | 7 | 257 | 0 | 28 |
| 2015 | 12 | 225 | 0 | 11 |
| 2016 | 9 | 218 | 2 | 15 |
| 2017 | 12 | 111 | 1 | 20 |
| 2018 | 7 | 194 | 8 | 15 |
| 2019 | 11 | 204 | 0 | 51 |
| 2020 | 15 | 117 | 0 | 15 |
| 2021 | 14 | 199 | 0 | 14 |
| 2022 | 6 | 127 | 2 | 10 |
| 2023 | 14 | 185 | 2 | 28 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 21 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231973: PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231973
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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