510(k) · Cleared
ClearedPowder-Free Radiation Attenuating Neoprene Surgical Glove (Black)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical, Inc. · KGO Surgeon'S Gloves
Cleared on Mar 21, 2003 as substantially equivalent to K891968 (Boston Scientific Corp, 1989) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 21, 2003
- Review
- 204 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K891968 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891968 Esp Radiation Reduction Examination GlovesBoston Scientific Corp · 1989
- This deviceK022873 Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black)International Biomedical, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891968 | Esp Radiation Reduction Examination Gloves | Boston Scientific Corp | 1989 | — |
| 0 (this device) | K022873 | Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black) | International Biomedical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K821720 | FDA’s K821720 is Physiological Display System, Model 1000 Our reading of the summary gave K821720, FDA’s number for Physiological Display System, Model 1000 (Novametrix Medical Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Radiation Attenuating Surgical Glove”. Kept off the family tree. | 1982 |
| * | K891968 | Esp Radiation Reduction Examination GlovesSummary page 1…International Biomedical, Inc. (82kl720) and the ESP Radiation Recustion Examination Gloves by Boston Scientific (k89 1968) and BarrierPlus Synthetic Powder-Free Surgical Gloves y BarrierMed Glove Company… | 1989 |
| * | K990710 | Barrierplus Synthetic Powder-Free Surgical GlovesSummary page 1…by Boston Scientific (k89 1968) and BarrierPlus Synthetic Powder-Free Surgical Gloves y BarrierMed Glove Company (k9907 10). Description: The Powder-Free Radiation Attenuating Surgical Gloves are forniulated… | 1999 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
A powder-free surgeon’s glove is a device made of synthetic latex that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The radiation attenuating surgical glove is intended to be used during medical procedures where hands are necessarily exposed to radiation in order to offer some degree of protection to the hand from radiation. This includes surgical procedures that require the use of fluoroscopy or radiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022873: Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022873
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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