Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Summary
Grand Work Plastic Products Co., Ltd. received 510(k) clearance for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, a LZA device. Cleared on 2023-08-09.
Details
Source
510(k) Clearance
External ID
K232039
Action Date
2023-08-09
Status
Special
Category
device
Product Code
LZA
Product Description
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. 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. Grand Work Plastic Products Co., Ltd. has received 8 total clearances in our database.
Grand Work Plastic Products Co., Ltd. has 8 FDA actions in our database, including 8 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 Grand Work Plastic Products Co., Ltd. have FDA actions?
Grand Work Plastic Products Co., Ltd. has 8 FDA actions in our database, including 0 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232039" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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