Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
FDA 510(k) clearance K212633 · decided 2021-11-24
Clearance details
- K-number
- K212633
- Device name
- Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
- Applicant
- String King Lacrosse, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-08-19
- Decision date
- 2021-11-24
- Days to decision
- 97 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
- Gardena, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch String King Lacrosse
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.