510(k) · Cleared
ClearedSurgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Purna Bina Sdn Bhd · KGO Surgeon'S Gloves
Cleared on Sep 30, 2014 after a 585-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Sep 30, 2014
- Review
- 585 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK130450 Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated…Purna Bina Sdn Bhd · 2014
- Descendant · cites it directly · 12 of its ownK151114 Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex…St. Marys Rubbers Pvt, Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK172942 Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with…Beta Healthcare Products Pvt., Ltd. · 2018
- Descendant · 2 generations on · 8 of its ownK192328 JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
- Descendant · 3 generations on · 2 of its ownK212848 Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd · 2021
- Descendant · 3 generations on · 1 of its ownK212596 Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K151114Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves…St. Marys Rubbers Pvt, Ltd. · 2015 · cites it directly12descendants
- K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content…Beta Healthcare Products Pvt., Ltd. · 2018 · cites it directly11descendants
- K192328JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020 · 2 generations on8descendants
- K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd · 2021 · 3 generations on2descendants
- K212596Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130450 | Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical… | Purna Bina Sdn Bhd | 2014 | — |
| +1 | 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 | — |
| +2 | K192328 | JR.MEDIK Latex Surgeon’s Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020 | — |
| +3 | K212848 | Sterile Latex Surgical Gloves Powder Free | Pentavest Holdings Sdn Bhd | 2021 | — |
| +3 | K212596 | Sterile Latex Surgical Gloves Powder Free | Amazing Rubber Products Pvt, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K151114 (St. Marys Rubbers Pvt, Ltd., 2015) has gone furthest, with 12 descendants 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?
This 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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130450: Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130450
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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