Procedure mask/Surgical mask/Face mask
Summary
Winner Medical Co., Ltd. received 510(k) clearance for Procedure mask/Surgical mask/Face mask, a FXX device. Cleared on 2025-06-18.
Details
Source
510(k) Clearance
External ID
K250082
Action Date
2025-06-18
Status
Traditional
Category
device
Product Code
FXX
Product Description
Procedure mask/Surgical mask/Face mask. Product code: FXX.
Company
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. Winner Medical Co., Ltd. has received 14 total clearances in our database.
Winner Medical Co., Ltd. has 14 FDA actions in our database, including 14 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 Winner Medical Co., Ltd. have FDA actions?
Winner Medical Co., Ltd. has 14 FDA actions in our database, including 0 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250082" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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