Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
FDA 510(k) clearance K230610 · decided 2023-08-23
Clearance details
- K-number
- K230610
- Device name
- Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
- Applicant
- Dongguan Shin YI Healthcare Products Factory
- Decision
- Substantially Equivalent
- Date received
- 2023-03-06
- Decision date
- 2023-08-23
- Days to decision
- 170 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
- Dong Guan, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dongguan Shin YI Healthcare Products Factory
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.