510(k) K212460
K212460 is an FDA 510(k) premarket notification submitted by Guangzhou Zhengkang Medical Equipment Co.,Ltd for the device "Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))". The FDA issued a decision of Substantially Equivalent on Nov 5, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Guangzhou Zhengkang Medical Equipment Co.,Ltd has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 5, 2021
- Date Received
- Aug 5, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
- 510(k)