Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
Summary
American Nitrile Operations, LLC received 510(k) clearance for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, a LZA device. Cleared on 2022-07-08.
Details
Source
510(k) Clearance
External ID
K220825
Action Date
2022-07-08
Status
Abbreviated
Category
device
Product Code
LZA
Product Description
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves. 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.
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 American Nitrile Operations, LLC have FDA actions?
This is the only FDA action we have on record for American Nitrile Operations, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220825" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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