FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Surgical Mask (non sterile)
K Number: K211451
·
Decision Aug 25, 2021
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
3
Review Days
107
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Disposable Surgical Mask (non sterile)
- K Number
- K211451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qinhuangdao Taizhi Medical Technology Co., Ltd.
- Date Received
- May 10, 2021
- Decision Date
- August 25, 2021
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXX), ordered by most recent decision date.
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surgical Face Mask (Ear mount)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Surgical Face Mask (3P00B, C2900)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Medical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KP Protective Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery