510(k) · Cleared
ClearedNuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terang Nusa Sdn Bhd · KGO Surgeon'S Gloves
Cleared on Oct 20, 2005 as substantially equivalent to K040503 (Wrp Asia Pacific Sdn. Bhd., 2004) after a 129-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Oct 20, 2005
- Review
- 129 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032942 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK032942 Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2003
- 1 generation backK040503 Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2004 · Recalled
- This deviceK051562 Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile…Terang Nusa Sdn Bhd · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032942 | Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile | Wrp Asia Pacific Sdn. Bhd. | 2003 | — |
| −1 | K040503 | Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2004 | 1 |
| 0 (this device) | K051562 | Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove… | Terang Nusa Sdn Bhd | 2005 | — |
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 |
|---|---|---|---|
| * | K040503 | Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with… Our OCR of the scanned summary read K040303, FDA’s number for 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens (Hydrogel Vision Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aloe Touch powder free polymer coated polyisoprene surgical gloves…”. | 2004 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Sugeon's Glove is a device made of synthetic 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/K051562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051562: Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051562
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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