510(k) · Cleared
ClearedMedispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Hbm Health Protections, Inc. · KGO Surgeon'S Gloves
Cleared on Feb 1, 2021 as substantially equivalent to K171047 (Better Care Plastic Technology Co., Ltd., 2017) and 1 other predicate after a 66-day review. Its family tree reaches back 6 generations to 2005.
- Decided
- Feb 1, 2021
- Review
- 66 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K050071 (2005). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK050071 Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005
- 5 generations backK063757 Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007
- 4 generations backK130301 Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc. · 2013
- 3 generations backK151114 Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex…St. Marys Rubbers Pvt, Ltd. · 2015
- 2 generations backK172942 Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with…Beta Healthcare Products Pvt., Ltd. · 2018
- 1 generation backK192328 JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
- This deviceK203483 Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K050071 | Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove | H.B.M. USA Co.,Inc. | 2005 | — |
| −5 | K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves | Shanghai Motex Healthcare Co., Ltd. | 2007 | — |
| −4 | K130301 | Latex Surgeon's Gloves (Powdered and Powder Free) | Elimedical Devices (Fujian), Inc. | 2013 | — |
| −3 | K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s… | St. Marys Rubbers Pvt, Ltd. | 2015 | — |
| −2 | K172942 | Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein… | Beta Healthcare Products Pvt., Ltd. | 2018 | — |
| −1 | K192328 | JR.MEDIK Latex Surgeon’s Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020 | — |
| 0 (this device) | K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K171047 | Sterile Polyisoprene Powder Free Surgical GlovesSummary page 4…CFR 878.4460 Regulatory Class: Class I Product code: KGO Review Panel General Hospital III. Predicate Devices a. 510(k) Number: K171047 Trade name: Sterile Polyisoprene Powder Free Surgical Gloves Common name: Surgeon’s Gloves Classifi… | 2017 |
| * | K192328 | JR.MEDIK Latex Surgeon’s Gloves Powder FreeSummary page 4…urgeon’s Gloves Classification: Class I Product Code: KGO Manufacturer Better Care Plastic Technology Co., Ltd. b. 510(k) Number: K192328 Trade name: JR Medic Latex Surgeon’s Gloves Sterile Powder Free Common name: Surgeon’s Gloves Class… | 2020 |
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 16 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K171047.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Medispo Rubber/Polyisoprene surgical gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203483: Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203483
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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