510(k) · Cleared
ClearedSterile Latex Powder Free Surgical Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protect Gloves Company Limited · KGO Surgeon'S Gloves
Cleared on May 22, 2026 as substantially equivalent to K212848 (Pentavest Holdings Sdn Bhd, 2021) after a 242-day review. Its family tree reaches back 7 generations to 2005.
- Decided
- May 22, 2026
- Review
- 242 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K050071 (2005). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK050071 Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005
- 6 generations backK063757 Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007
- 5 generations backK130301 Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc. · 2013
- 4 generations backK151114 Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex…St. Marys Rubbers Pvt, Ltd. · 2015
- 3 generations backK172942 Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with…Beta Healthcare Products Pvt., Ltd. · 2018
- 2 generations backK192328 JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
- 1 generation backK212848 Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd · 2021
- This deviceK253060 Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K050071 | Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove | H.B.M. USA Co.,Inc. | 2005 | — |
| −6 | K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves | Shanghai Motex Healthcare Co., Ltd. | 2007 | — |
| −5 | K130301 | Latex Surgeon's Gloves (Powdered and Powder Free) | Elimedical Devices (Fujian), Inc. | 2013 | — |
| −4 | K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s… | St. Marys Rubbers Pvt, Ltd. | 2015 | — |
| −3 | K172942 | Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein… | Beta Healthcare Products Pvt., Ltd. | 2018 | — |
| −2 | K192328 | JR.MEDIK Latex Surgeon’s Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020 | — |
| −1 | K212848 | Sterile Latex Surgical Gloves Powder Free | Pentavest Holdings Sdn Bhd | 2021 | — |
| 0 (this device) | K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K212848 | Sterile Latex Surgical Gloves Powder FreeSummary page 5…: Surgeon’s Gloves Classification: Class I Product code: KGO Regulation Number: 21 CFR 878.4460 Review Panel: General & Plastic Surgery C. Predicate device: K212848 Applicant: Pentavest Holdings Sdn Bhd Device Name: Sterile Latex Surgical Gloves powder free… | 2021 |
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 21 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K212848.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Sterile Latex Powder Free Surgical Gloves 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/K253060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253060: Sterile Latex Powder Free Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253060
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026