Disposable Medical Face Mask (ear loop)
Summary
Xiantao Topmed Nonwoven Protective Products Co., Ltd. received 510(k) clearance for Disposable Medical Face Mask (ear loop), a FXX device. Cleared on 2022-07-22.
Details
Source
510(k) Clearance
External ID
K221196
Action Date
2022-07-22
Status
Traditional
Category
device
Product Code
FXX
Product Description
Disposable Medical Face Mask (ear loop). 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. Xiantao Topmed Nonwoven Protective Products Co., Ltd. has received 2 total clearances in our database.
Xiantao Topmed Nonwoven Protective Products 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 Xiantao Topmed Nonwoven Protective Products Co., Ltd. have FDA actions?
Xiantao Topmed Nonwoven Protective Products 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 "K221196" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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