Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
Summary
Anhui Xinyisheng Medical Technology Co.,Ltd received 510(k) clearance for Disposable Medical Nitrile Examination Gloves (Model:XYS-001), a LZA device. Cleared on 2021-12-09.
Details
Source
510(k) Clearance
External ID
K213371
Action Date
2021-12-09
Status
Traditional
Category
device
Product Code
LZA
Product Description
Disposable Medical Nitrile Examination Gloves (Model:XYS-001). 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. Anhui Xinyisheng Medical Technology Co.,Ltd has received 2 total clearances in our database.
Anhui Xinyisheng Medical Technology 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 Anhui Xinyisheng Medical Technology Co.,Ltd have FDA actions?
Anhui Xinyisheng Medical Technology 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 "K213371" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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