510(k) · Cleared
ClearedLatex Surgical Gloves, Pre-Powdered
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fitco Dipped Products Pvt., Ltd. · KGO Surgeon'S Gloves
Cleared on Dec 29, 1999 as substantially equivalent to K904972 (Kanam Latex Industries Pvt., Ltd., 1991) after a 78-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Dec 29, 1999
- Review
- 78 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904972 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK904972 Surgicare Sterile Surgical GlovesKanam Latex Industries Pvt., Ltd. · 1991
- This deviceK993450 Latex Surgical Gloves, Pre-PowderedFitco Dipped Products Pvt., Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904972 | Surgicare Sterile Surgical Gloves | Kanam Latex Industries Pvt., Ltd. | 1991 | — |
| 0 (this device) | K993450 | Latex Surgical Gloves, Pre-Powdered | Fitco Dipped Products Pvt., Ltd. | 1999 | — |
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 |
|---|---|---|---|
| * | K904972 | Surgicare Sterile Surgical GlovesSummary page 1…requirements of ASTM D3577-91. The equivalent device identified in the market is the Latex Surgical Gloves marketed by Kanam Latex Industries Pvt. Ltd., INDIA [510K NO. K904972] under brand name SURGICARE 4. Device Description : Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21… | 1991 |
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.
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?
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination.
Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction.
Contents sterile until package is opened or damaged.
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/K993450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993450: Latex Surgical Gloves, Pre-Powdered.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993450
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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