Disposable Surgical Gown, Disposable Reinforced Surgical Gown
Summary
Fugou County Shenxiang Manufacturing Co., Ltd. received 510(k) clearance for Disposable Surgical Gown, Disposable Reinforced Surgical Gown, a FYA device. Cleared on 2021-12-13.
Details
Source
510(k) Clearance
External ID
K212869
Action Date
2021-12-13
Status
Traditional
Category
device
Product Code
FYA
Product Description
Disposable Surgical Gown, Disposable Reinforced Surgical Gown. Product code: FYA.
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.
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 Fugou County Shenxiang Manufacturing Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Fugou County Shenxiang Manufacturing Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212869" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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