Nitrile disposable examination gloves
Summary
Xingyu Medical Tech Co., Ltd. received 510(k) clearance for Nitrile disposable examination gloves, a LZA device. Cleared on 2021-12-02.
Details
Source
510(k) Clearance
External ID
K212578
Action Date
2021-12-02
Status
Traditional
Category
device
Product Code
LZA
Product Description
Nitrile disposable examination gloves. Product code: LZA.
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. Xingyu Medical Tech Co., Ltd. has received 4 total clearances in our database.
Xingyu Medical Tech Co., Ltd. has 4 FDA actions in our database, including 4 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 Xingyu Medical Tech Co., Ltd. have FDA actions?
Xingyu Medical Tech Co., Ltd. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212578" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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