K242689 is an FDA 510(k) clearance for the AAMI Level 4 Protective. 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 Azac Group (City Of Industry, US). The FDA issued a Cleared decision on January 13, 2025, 129 days after receiving the submission on September 6, 2024.
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 | K242689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2024 |
| Decision Date | January 13, 2025 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| 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. |