Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, an
Summary
Sri Trang Gloves (Thailand) Public Company Limited received 510(k) clearance for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue), a LZA device. Cleared on 2024-05-13.
Details
Source
510(k) Clearance
External ID
K232614
Action Date
2024-05-13
Status
Abbreviated
Category
device
Product Code
LZA
Product Description
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue). 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. Sri Trang Gloves (Thailand) Public Company Limited has received 5 total clearances in our database.
Sri Trang Gloves (Thailand) Public Company Limited 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 Sri Trang Gloves (Thailand) Public Company Limited have FDA actions?
Sri Trang Gloves (Thailand) Public Company Limited 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 "K232614" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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