Disposable Surgical Face Mask
Summary
Shandong Zhushi Pharmaceutical Group Co., Ltd. received 510(k) clearance for Disposable Surgical Face Mask, a FXX device. Cleared on 2021-07-28.
Details
Source
510(k) Clearance
External ID
K210409
Action Date
2021-07-28
Status
Traditional
Category
device
Product Code
FXX
Product Description
Disposable Surgical 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. Shandong Zhushi Pharmaceutical Group Co., Ltd. has received 3 total clearances in our database.
Shandong Zhushi Pharmaceutical Group Co., Ltd. has 3 FDA actions in our database, including 3 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 Shandong Zhushi Pharmaceutical Group Co., Ltd. have FDA actions?
Shandong Zhushi Pharmaceutical Group Co., Ltd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K210409" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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