510(k) · Cleared
ClearedSurgeon's Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Health Products, Inc. · KGO Surgeon'S Gloves
Cleared on Jan 29, 1998 as substantially equivalent to K832448 (Travenol Laboratories, S.A., 1984) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jan 29, 1998
- Review
- 71 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832448 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832448 Triflex Surgeon's GlovesTravenol Laboratories, S.A. · 1984
- This deviceK974356 Surgeon's GlovesAmerican Health Products, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832448 | Triflex Surgeon's Gloves | Travenol Laboratories, S.A. | 1984 | — |
| 0 (this device) | K974356 | Surgeon's Gloves | American Health Products, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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? (2)
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 |
|---|---|---|---|
| * | K832448 | Triflex Surgeon's GlovesSummary page 2…79 KGO 2. Substantial Equivalence Comparison Product The device is compared to i) Product : Triflex Surgeon’s Glove Manufactured by : Travenol Laboratories 510¢k) : K832448 Classification : Surgeon’s Glove 21 CFR Part 878.4460 Quality Standard : ASTM D-3577 i1) Product : Comfit Surgeon’s Glove Manuf… | 1984 |
| * | K903446 | Comfit Surgeon's GlovesSummary page 2…ification : Surgeon’s Glove 21 CFR Part 878.4460 Quality Standard : ASTM D-3577 i1) Product : Comfit Surgeon’s Glove Manufactured by : Wembley Rubber Products 510¢k) : K903446 Classification : Surgeon’s Glove 21 CFR Part 878.4460 Quality Standard ; ASTM D-3577 3. Intended Use of Device The surgeon’s g… | 1990 |
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?
The surgeon’s gloves are sterile gloves to be worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
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/K974356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974356: Surgeon's Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974356
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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