Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
Summary
Shandong Xingyu Gloves Co., Ltd. received 510(k) clearance for Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000), a LZA device. Cleared on 2024-04-01.
Details
Source
510(k) Clearance
External ID
K233990
Action Date
2024-04-01
Status
Traditional
Category
device
Product Code
LZA
Product Description
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000). 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. Shandong Xingyu Gloves Co., Ltd. has received 2 total clearances in our database.
Shandong Xingyu Gloves 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 Shandong Xingyu Gloves Co., Ltd. have FDA actions?
Shandong Xingyu Gloves 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 "K233990" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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