510(k) · Cleared
ClearedProfeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile
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 Dec 17, 2003 after an 86-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Dec 17, 2003
- Review
- 86 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK032942 Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2003
- Descendant · cites it directly · 1 of its ownK222058 Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use…Wrp Asia Pacific Sdn. Bhd. · 2022
- Descendant · cites it directly · 1 of its ownK040503 Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK230578 Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested…Wrp Asia Pacific Sdn. Bhd. · 2023
- Descendant · 2 generations on · 0 of its ownK051562 Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile…Terang Nusa Sdn Bhd · 2005
Most influential descendants
Showing 4 of 4 · See all- K222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy…Wrp Asia Pacific Sdn. Bhd. · 2022 · cites it directly1descendant
- K040503Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with…Wrp Asia Pacific Sdn. Bhd. · 2004 · cites it directly1descendant
- K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…Wrp Asia Pacific Sdn. Bhd. · 2023 · 2 generations on0descendants
- K051562Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe…Terang Nusa Sdn Bhd · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032942 | Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile | Wrp Asia Pacific Sdn. Bhd. | 2003 | — |
| +1 | K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2022 | — |
| +1 | K040503 | Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2004 | 1 |
| +2 | K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use… | Wrp Asia Pacific Sdn. Bhd. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | Class I Powder Free Synthetic rubber latex surgeon's gloves Named without a submission number |
What descends from it? (4)
2 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, K222058 (Wrp Asia Pacific Sdn. Bhd., 2022) has gone furthest, with 1 descendant 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.
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 as stated in the FDA summary.
https://510kreport.com/device/K032942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032942: Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032942
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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