510(k) · Cleared
ClearedPowdered Free Sterile Natural Rubber Latex Surgical Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Egyptian Company For Medical & Electronic Industries · KGO Surgeon'S Gloves
Cleared on Aug 16, 2023 as substantially equivalent to K211953 (Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., 2022) after a 142-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Aug 16, 2023
- Review
- 142 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K964474 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK964474 Ultrafree Sterile Latex Powder-Free Surgical GlovesAllegiance Healthcare Corp. · 1997
- 5 generations backK120934 Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with…Cardinal Health, Inc. · 2012
- 4 generations backK121897 Protexis Latex Basic Sterile Powder-Free Surgical GlovesCardinal Health, Inc. · 2012
- 3 generations backK140988 Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name…Hebei Hongsen Plastics Technology Co, Ltd. · 2014
- 2 generations backK171550 Sterile Latex Surgical Gloves, Powder FreeSanrea Healthcare Products Pvt, Ltd. · 2018
- 1 generation backK211953 Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2022
- This deviceK230832 Powdered Free Sterile Natural Rubber Latex Surgical GlovesThe Egyptian Company For Medical & Electronic Industries · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964474 | Ultrafree Sterile Latex Powder-Free Surgical Gloves | Allegiance Healthcare Corp. | 1997 | — |
| −5 | K120934 | Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein… | Cardinal Health, Inc. | 2012 | — |
| −4 | K121897 | Protexis Latex Basic Sterile Powder-Free Surgical Gloves | Cardinal Health, Inc. | 2012 | — |
| −3 | K140988 | Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine) | Hebei Hongsen Plastics Technology Co, Ltd. | 2014 | — |
| −2 | K171550 | Sterile Latex Surgical Gloves, Powder Free | Sanrea Healthcare Products Pvt, Ltd. | 2018 | — |
| −1 | K211953 | Disposable Sterilized Latex Surgical Gloves | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022 | — |
| 0 (this device) | K230832 | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries | 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 |
|---|---|---|---|
| * | K211953 | Disposable Sterilized Latex Surgical GlovesSummary page 4…n Name: Non-powdered surgeon's glove. Product Code: KGO Regulation number: 21CFR 878.4460 Device Class: I 510(k) Number: K230832 III. PREDICATE DEVICE 510(k) Number: K211953 Clearing date: 25/05/2022 Product Name: Disposable Sterilized Latex Surgical Gloves Submitter: Jiangxi Kemei Medical Apparatus &… | 2022 |
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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 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. 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 powdered free sterile natural rubber latex surgical gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230832: Powdered Free Sterile Natural Rubber Latex Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230832
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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