Protect X Level 3 Isolation Gown — Azac Group (510(k) K211538)
Protect X Level 3 Isolation Gown — Azac Group (510(k) K211538) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Protect X Level 3 Isolation Gown; Applicant: Azac Group; Clearance track: 510(k).
| Device name | Protect X Level 3 Isolation Gown |
|---|---|
| Applicant | Azac Group |
| Clearance track | 510(k) |
| Submission number | K211538 |
| Decision | Substantially Equivalent |
| Decision date | 2021-11-17 |
| Date received | 2021-05-18 |
| Product code | FYC |
| Device class | 2 |
| Medical specialty | General, Plastic Surgery |
| Applicant location | CA, US |
| Source | openFDA device |
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$1999/mo
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