510(k) · Cleared
ClearedPolychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pt. Medisafe Technologies · KGO Surgeon'S Gloves
Cleared on Mar 28, 2019 after a 230-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Mar 28, 2019
- Review
- 230 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK182176 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested…Pt. Medisafe Technologies · 2019
- Descendant · cites it directly · 12 of its ownK190860 Disposable Powder Free Nitrile Examination Glove, Tested For Use…Ever Growth (Vietnam) Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK230847 Chemotherapy Gloves3A Glove Sdn. Bhd. · 2023
- Descendant · 2 generations on · 0 of its ownK214056 Disposable Nitrile Inspection Gloves (Tested for Use with…Mezorrison Medical Technology (Dongying) Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK221271 Disposable Nitrile Powder-Free Examination Gloves (Tested for Use…Shandong Maida Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK220488 Disposable Nitrile Powder-Free Examination Gloves (Tested for Use…Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K190860Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy…Ever Growth (Vietnam) Co., Ltd. · 2019 · cites it directly12descendants
- K230847Chemotherapy Gloves3A Glove Sdn. Bhd. · 2023 · 2 generations on0descendants
- K214056Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)Mezorrison Medical Technology (Dongying) Co., Ltd. · 2022 · 2 generations on0descendants
- K221271Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)Shandong Maida Medical Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K220488Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use… | Pt. Medisafe Technologies | 2019 | — |
| +1 | K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With… | Ever Growth (Vietnam) Co., Ltd. | 2019 | — |
| +2 | K230847 | Chemotherapy Gloves | 3A Glove Sdn. Bhd. | 2023 | — |
| +2 | K214056 | Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) | Mezorrison Medical Technology (Dongying) Co., Ltd. | 2022 | — |
| +2 | K221271 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with… | Shandong Maida Medical Technology Co., Ltd. | 2022 | — |
| +2 | K220488 | Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with… | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy… | 2019 | 12 |
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, K190860 (Ever Growth (Vietnam) Co., Ltd., 2019) has gone furthest, with 12 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. 2019, 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?
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. Test Chemotherapy Drug and Concentration Breakthrough Detection Time (Minutes) Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 37.5 (47.8, 38.3, 37.5) Cisplatin 1.0 mg/ml (1,000ppm) >240…
Read the full statement (185 words)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Test Chemotherapy Drug and Concentration Breakthrough Detection Time (Minutes)
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 37.5 (47.8, 38.3, 37.5)
Cisplatin 1.0 mg/ml (1,000ppm) >240 min
Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) >240 min
Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) >240 min
Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 min
Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 min
Fluorouracil 50.0 mg/ml (50,000 ppm) >240 min
Ifosfamide 50.0 mg/ml (50,000 ppm) >240 min
Methotrexate 25 mg/ml (25, 000 ppm) >240 min
Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) >240 min
Melphalan 5 mg/ml (5,000 ppm) >240 min
Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 min
Thiotepa 10.0 mg/ml (10,000 ppm) 58.3 (69.8, 68.6, 58.3)
Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240 min
Please note that the following drugs have low permeation times:
Carmustine (3.3 mg/ml): 37.5 minutes ThioTEPA (10.0 mg/ml): 58.3 minutes
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K182176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182176: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182176
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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