510(k) K182830
K182830 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Cardinal HealthTM Poly-Coated Open-Back Protective Gown". The FDA issued a decision of Substantially Equivalent on April 26, 2019. 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. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2019
- Date Received
- October 5, 2018
- 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.