Cardinal Health Isolation Gown
FDA 510(k) clearance K160339 · decided 2016-07-28
Clearance details
- K-number
- K160339
- Device name
- Cardinal Health Isolation Gown
- Applicant
- Cardinal Health200, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-02-08
- Decision date
- 2016-07-28
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- FYC
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200 recall (Z-0674-2025) | Cardinal Health 200, LLC | 2024-12-11 |
| Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Code recall (Z-0675-2025) | Cardinal Health 200, LLC | 2024-12-11 |