510(k) K261811
K261811 is an FDA 510(k) premarket notification submitted by PRIMED Medical Products, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on September 1, 2026. The device falls under product code QSO (Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs), a Class II device regulated under 21 CFR 878.4040. PRIMED Medical Products, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2026
- Date Received
- June 1, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
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.