Medline Surgical Face Mask and Medline Procedural Face Mask— 510(k) K223236
Substantially EquivalentMedline Industries, LP
FDA 510(k) clearance K223236 for Medline Surgical Face Mask and Medline Procedural Face Mask, Substantially Equivalent on 2023-03-24. Applicant: Medline Industries, LP. Device class: 2.
Clearance details
- Applicant
- Medline Industries, LP
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
Recent devices under product code FXX
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- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
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Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.