510(k) · Cleared
Recalled · Class II · 2017Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrp Asia Pacific Sdn. Bhd. · KGO Surgeon'S Gloves
Cleared on Mar 16, 2004 as substantially equivalent to K032942 (Wrp Asia Pacific Sdn. Bhd., 2003) after an 18-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 16, 2004
- Review
- 18 days
- Class
- Class I
- Product code
- KGO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032942 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK032942 Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2003
- This deviceK040503 Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2004
- Descendant · cites it directly · 0 of its ownK051562 Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile…Terang Nusa Sdn Bhd · 2005
Most influential descendants
Showing 1 of 1 · See all- K051562Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe…Terang Nusa Sdn Bhd · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032942 | Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile | Wrp Asia Pacific Sdn. Bhd. | 2003 | — |
| 0 (this device) | K040503 | Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2004 | — |
| +1 | K051562 | Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove… | Terang Nusa Sdn Bhd | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K032942 | Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, SterileSummary page 1…lent to the exiting model, i.e. Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile which had submitted and cleared under 510(k) number K03 2942. Page l of3… | 2003 |
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 |
|---|---|---|---|
| K051562 | Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe… | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2017 | Class II | Z-0162-2018 | Packaging | Possible open seal on top portion of the package. Could cause breach of sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or 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/K040503 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040503: Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040503
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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