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)
FDA 510(k) K261811 · PRIMED Medical Products, Inc.
Submission
- Device name
- 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)
- Applicant
- PRIMED Medical Products, Inc.
Edmonton, CA - Received
- June 1, 2026
- Decision date
- September 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSO – Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.
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|---|---|---|
| K262007 | PRIMED AAMI Level 3 Open Back GownsQPC · Traditional | 09/11/2026SE |
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| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 10/07/2024SE |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure MasksFXX · Traditional | 08/26/2024SE |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG · Traditional | 05/24/2024SE |
| K213427 | PRIMED Pediatric FacemaskOXZ · Traditional | 11/22/2022SE |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC · Traditional | 11/04/2016SE |
| K092012 | Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model…FXX · Special | 09/25/2009SE |
| K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksFXX · Special | 08/11/2008SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K261811) received a 510(k) decision of Substantially Equivalent on September 1, 2026, 92 days after the submission was received.
What is the product code of K261811?
The FDA product code is QSO – Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs, a Class II (moderate risk) device regulated under 21 CFR 878.4040.