510(k) · Cleared
ClearedLatex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lenora Glove Pvt, Ltd. · KGO Surgeon'S Gloves
Cleared on Oct 24, 2019 as substantially equivalent to K172942 (Beta Healthcare Products Pvt., Ltd., 2018) after a 226-day review. Its family tree reaches back 5 generations to 2005. 1 later device descends from it.
- Decided
- Oct 24, 2019
- Review
- 226 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K050071 (2005). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK050071 Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005
- 4 generations backK063757 Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007
- 3 generations backK130301 Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc. · 2013
- 2 generations backK151114 Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex…St. Marys Rubbers Pvt, Ltd. · 2015
- 1 generation backK172942 Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with…Beta Healthcare Products Pvt., Ltd. · 2018
- This deviceK190632 Latex Surgeon’s Gloves Powder Free with protein content labeling…Lenora Glove Pvt, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK202401 Powder Free NR Latex Surgical Glove (Sterile) with Protein content…Eco Medi Glove Sdn. Bhd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims…Eco Medi Glove Sdn. Bhd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K050071 | Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove | H.B.M. USA Co.,Inc. | 2005 | — |
| −4 | K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves | Shanghai Motex Healthcare Co., Ltd. | 2007 | — |
| −3 | K130301 | Latex Surgeon's Gloves (Powdered and Powder Free) | Elimedical Devices (Fujian), Inc. | 2013 | — |
| −2 | K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s… | St. Marys Rubbers Pvt, Ltd. | 2015 | — |
| −1 | K172942 | Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein… | Beta Healthcare Products Pvt., Ltd. | 2018 | — |
| 0 (this device) | K190632 | Latex Surgeon’s Gloves Powder Free with protein content labeling claim of… | Lenora Glove Pvt, Ltd. | 2019 | — |
| +1 | K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling… | Eco Medi Glove Sdn. Bhd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K172942 | Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content…Summary page 5…REDICATE DEVICE INFORMATION Name of devices 510k Number 510K Owner Predicate device “PRISTEEN” Latex Surgeon’s K172942 Beta Health Care products Glove powder free with Pvt.Ltd,Plot No 21B,… | 2018 |
| † | K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims… | 2021 | 0 |
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 14 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K202401 (Eco Medi Glove Sdn. Bhd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172942.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190632: Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190632
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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