510(k) · Cleared
ClearedPowder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hebei Hongsen Plastics Technology Co, Ltd. · KGO Surgeon'S Gloves
Cleared on Dec 22, 2014 as substantially equivalent to K122557 (Shanghai Motex Healthcare Co., Ltd., 2013) after a 249-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 22, 2014
- Review
- 249 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013302 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
- 2 generations backK102500 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc. · 2010
- 1 generation backK122557 Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2013
- This deviceK140989 Powder Free Nitrile Surgical Gloves, White Color (Brand Name…Hebei Hongsen Plastics Technology Co, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK170515 Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited · 2017
- Descendant · 2 generations on · 0 of its ownK222350 Sterile Nitrile Surgical Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use… | Allegiance Healthcare Corp. | 2001 | — |
| −2 | K102500 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating | Cardinal Health, Inc. | 2010 | — |
| −1 | K122557 | Motex Powder-Free Nitrile Surgical Gloves | Shanghai Motex Healthcare Co., Ltd. | 2013 | — |
| 0 (this device) | K140989 | Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine) | Hebei Hongsen Plastics Technology Co, Ltd. | 2014 | — |
| +1 | K170515 | Sterile Nitrile Surgical Gloves, Powder-free | Primus Gloves Pvt Limited | 2017 | — |
| +2 | K222350 | Sterile Nitrile Surgical Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K122557 | Motex Powder-Free Nitrile Surgical GlovesSummary page 4…ulation Number: 21 CFR 878.4460 Panel: General General & Plastic Surgery Product Code: KGO 5.5 Predicate Device Information: (1) K122557, “Motex Powder Free Nitrile Surgical Gloves, White and Green Color”, manufactured by “Shanghai Motex Healthcare Co., Ltd.” Se… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170515 | Sterile Nitrile Surgical Gloves, Powder-free | 2017 | 1 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K170515 (Primus Gloves Pvt Limited, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 powder free nitrile surgical glove, white color (Brand Name: Titanfine), is a sterile and single use device made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140989: Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140989
Report an extraction error
Are you the manufacturer?
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