510(k) K233526
K233526 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Medline Open-back Level 3 Protective Gown". The FDA issued a decision of Substantially Equivalent on March 5, 2024. The device falls under product code QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection), a Class II device regulated under 21 CFR 878.4040. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2024
- Date Received
- November 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.