K210405 is an FDA 510(k) clearance for the ProTEC-USA EZDoff 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 Cadillac Products, Inc. (Troy, US). The FDA issued a Cleared decision on December 15, 2021, 308 days after receiving the submission on February 10, 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 | K210405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2021 |
| Decision Date | December 15, 2021 |
| Days to Decision | 308 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. |