Banded Face Mask
Summary
Hubei Medlink Healthcare Co., Ltd. received 510(k) clearance for Banded Face Mask, a FXX device. Cleared on 2022-11-18.
Details
Source
510(k) Clearance
External ID
K223003
Action Date
2022-11-18
Status
Special
Category
device
Product Code
FXX
Product Description
Banded Face Mask. Product code: FXX.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Hubei Medlink Healthcare Co., Ltd. has received 2 total clearances in our database.
Hubei Medlink Healthcare Co., Ltd. has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Hubei Medlink Healthcare Co., Ltd. have FDA actions?
Hubei Medlink Healthcare Co., Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223003" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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