510(k) · Cleared
ClearedPolychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hartalega NGC Sdn. Bhd. · OPC Powder-Free Polychloroprene Patient Examination Glove
Cleared on Aug 3, 2021 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 3, 2021
- Review
- 57 days
- Class
- Class I
- Product code
- OPC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 OPC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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?
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.
How does its category compare?
All OPC devicesOPC Powder-Free Polychloroprene Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OPC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OPC
Too few OPC 510(k)s in any year since 2007 to give a median.
Recalls per year · OPC
No recall names OPC since 2007.
Adverse event reports per year · OPC
1in 2023
MAUDE reports naming product code OPC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical…
Read the full statement (163 words)
Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes
Carmustine (3.3 mg/ml) 14.9
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide (20.0 mg/ml) >240
Dacarbazine (10.0 mg/ml) >240
Doxorubicin Hydrochloride (2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
Fluorouracil (50.0 mg/ml) >240
Methotrexate (25.0 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Paclitaxel (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) 22.9
Vincristine Sulfate (1.0 mg/ml) >240
Please note that Carmustine and Thiotepa have extremely low permeation times of 14.9 minutes and 22.9 minutes.
Warning: Do not use with Carmustine
Warning: Do not use with Thiotepa
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211758: Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026