510(k) · Cleared
ClearedProfeel Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim)
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 Jul 24, 2002 after a 55-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jul 24, 2002
- Review
- 55 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK021784 Profeel Powder Free Polymer Coated Brown Latex Surgical Gloves…Wrp Asia Pacific Sdn. Bhd. · 2002
- Descendant · cites it directly · 0 of its ownK070619 Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile…Wrp Asia Pacific Sdn. Bhd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070619Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera…Wrp Asia Pacific Sdn. Bhd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021784 | Profeel Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2002 | — |
| +1 | K070619 | Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with… | Wrp Asia Pacific Sdn. Bhd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 natural rubber latex Surgeon's gloves Named without a submission number |
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 |
|---|---|---|---|
| K070619 | Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera… | 2007 | 0 |
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, K070619 (Wrp Asia Pacific Sdn. Bhd., 2007) has gone furthest, with 0 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.
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 natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The surgeon’s glove is a device made of natural rubber latex intended to be worn by surgeons andor operating room personnel to protect a surgical wound from contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021784 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021784: Profeel Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021784
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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