510(k) · Cleared
ClearedPowdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shen Wei (Usa), Inc. · KGO Surgeon'S Gloves
Cleared on Mar 29, 2012 as substantially equivalent to K063757 (Shanghai Motex Healthcare Co., Ltd., 2007) after a 148-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Mar 29, 2012
- Review
- 148 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050071 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK050071 Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005
- 1 generation backK063757 Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007
- This deviceK113233 Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content…Shen Wei (Usa), Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050071 | Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove | H.B.M. USA Co.,Inc. | 2005 | — |
| −1 | K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves | Shanghai Motex Healthcare Co., Ltd. | 2007 | — |
| 0 (this device) | K113233 | Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling… | Shen Wei (Usa), Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesSummary page 1…ent Labeling Claim (50 micrograms or less) Common Name: Surgical Gloves Classification Name: Surgeon's gloves - 21 CFR 878.4460 Predicate Device: K063757 Motex Powder-Free Surgical Gloves and Powdered Latex surgical Gloves 4.0 Identification of the Legally Ma… | 2007 |
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 7 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K063757.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113233: Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113233
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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