510(k) · Cleared
ClearedTULIP Natural Rubber Latex Surgeon's Glove (Powdered)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Jinxiang Latex Products Co., Ltd. · KGO Surgeon'S Gloves
Cleared on Mar 18, 2015 as substantially equivalent to K063757 (Shanghai Motex Healthcare Co., Ltd., 2007) after a 153-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Mar 18, 2015
- Review
- 153 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050071 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK050071 Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005
- 1 generation backK063757 Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007
- This deviceK142992 TULIP Natural Rubber Latex Surgeon's Glove (Powdered)Shanghai Jinxiang Latex Products Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050071 | Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove | H.B.M. USA Co.,Inc. | 2005 | — |
| −1 | K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves | Shanghai Motex Healthcare Co., Ltd. | 2007 | — |
| 0 (this device) | K142992 | TULIP Natural Rubber Latex Surgeon's Glove (Powdered) | Shanghai Jinxiang Latex Products Co., Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesSummary page 4….4460 Panel: General& Plastic Surgery Product Code: KGO 3.0 Predicate device 510(K) Number: K063757 Device Name: Motex Powder-Free Surgical Gloves & Powdered Latex Surg… | 2007 |
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 10 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K063757.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
A latex surgeon's glove 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 as stated in the FDA summary.
https://510kreport.com/device/K142992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142992: TULIP Natural Rubber Latex Surgeon's Glove (Powdered).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142992
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