Disposable Vinyl Nitrile Synthetic Gloves Powder Free
Summary
Tangshan Hongyun Healthcare Products Co., Ltd. received 510(k) clearance for Disposable Vinyl Nitrile Synthetic Gloves Powder Free, a LYZ device. Cleared on 2021-07-24.
Details
Source
510(k) Clearance
External ID
K211262
Action Date
2021-07-24
Status
Traditional
Category
device
Product Code
LYZ
Product Description
Disposable Vinyl Nitrile Synthetic Gloves Powder Free. Product code: LYZ.
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. Tangshan Hongyun Healthcare Products Co., Ltd. has received 2 total clearances in our database.
Tangshan Hongyun Healthcare Products 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 Tangshan Hongyun Healthcare Products Co., Ltd. have FDA actions?
Tangshan Hongyun Healthcare Products 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 "K211262" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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