510(k) · Cleared
ClearedPRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PRIMED Medical Products, Inc. · QSO Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Cleared on Sep 1, 2026 as substantially equivalent to K101468 (3M Company Corp, 2011) after a 92-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Sep 1, 2026
- Review
- 92 days
- Class
- Class II
- Product code
- QSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K080795 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK080795 Ultra Surgical Gown & Fluid Barrier Surgical GownKimberly-Clark Corp. · 2008
- 1 generation backK101468 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown…3M Company Corp · 2011
- This deviceK261811 PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED…PRIMED Medical Products, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K080795 | Ultra Surgical Gown & Fluid Barrier Surgical Gown | Kimberly-Clark Corp. | 2008 | — |
| −1 | K101468 | 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M… | 3M Company Corp | 2011 | — |
| 0 (this device) | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug… | PRIMED Medical Products, Inc. | 2026 | — |
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 QSO? 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? (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 |
|---|---|---|---|
| * | K101468 | 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced…Summary page 5…Hospital Regulation number 878.4040 Device Class: 2 Product Code: QSO, FYC Predicate device(s) K101468 Reference Device K214108 Device Description: PRIMED Chemotherapy Drug Tested Gowns are non-sterile, sin… | 2011 |
| † | K214108 | Medline Orbis Chemo Surgical Gown | 2022 |
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 18 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QSO devicesQSO Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QSO
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QSO
Too few QSO 510(k)s in any year since 2007 to give a median.
Recalls per year · QSO
No recall names QSO since 2007.
Adverse event reports per year · QSO
No MAUDE report names QSO since 2007.
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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PRIMED Chemotherapy Drug Tested Gowns are non-sterile, single-use isolation gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. In addition, these gowns provide protection against chemotherapy drugs. The listed chemotherapy drugs showed no breakthrough within 480 minutes at a standardized breakthrough rate of 0.1 pg/cm?minute when tested…
Read the full statement (113 words)
PRIMED Chemotherapy Drug Tested Gowns are non-sterile, single-use isolation gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. In addition, these gowns provide protection against chemotherapy drugs. The listed chemotherapy drugs showed no breakthrough within 480 minutes at a standardized breakthrough rate of 0.1 pg/cm?minute when tested in accordance with ASTM F739:2020 standard.
Chemotherapy Drug Name
Carmustine (BiCNU). 3.3 mg/ml,
Cisplatin, 1 mg/ml,
Cyclophosphamide (Cytoxan), 20 mg/ml,
Dacarbazine, 10 mg/ml,
Doxorubicin Hydrochloride, 2 mg/mi,
Etoposide (Toposar), 20.0 mg/ml,
Fluorouracil, 50 mg/ml,
Mitomycin C, 0.5 mg/ml,
Paclitaxel (Taxol), 6 mg/ml,
Thio-Tepa (THT), 10 mg/ml,
Vincristine, 1 mg/ml
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261811: PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261811
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026