Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
Summary
Shen Wei USA, Inc. received 510(k) clearance for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors, a LYZ device. Cleared on 2021-12-22.
Details
Source
510(k) Clearance
External ID
K213144
Action Date
2021-12-22
Status
Traditional
Category
device
Product Code
LYZ
Product Description
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors. Product code: LYZ.
Company
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. Shen Wei USA, Inc. has received 5 total clearances in our database.
Shen Wei USA, Inc. has 5 FDA actions in our database, including 5 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 Shen Wei USA, Inc. have FDA actions?
Shen Wei USA, Inc. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213144" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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