Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
FDA 510(k) clearance K182172 · decided 2019-04-24
Clearance details
- K-number
- K182172
- Device name
- Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-10
- Decision date
- 2019-04-24
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Northfiled, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pa recall (Z-0711-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-01-11 |