K212464 is an FDA 510(k) clearance for the Dukal Corporation AAMI Level 4 Open-Back Protective Gown. This device is classified as a Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (Class II - Special Controls, product code QPC).
Submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on March 30, 2022, 236 days after receiving the submission on August 6, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040. 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..
| 510(k) Number | K212464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2021 |
| Decision Date | March 30, 2022 |
| Days to Decision | 236 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QPC - Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
| Definition | 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. |