Cardinal Health Poly Reinforced Surgical Gown
Summary
Cardinal Health 200, LLC received 510(k) clearance for Cardinal Health Poly Reinforced Surgical Gown, a FYA device. Cleared on 2026-04-28.
Details
Source
510(k) Clearance
External ID
K253243
Action Date
2026-04-28
Status
Abbreviated
Category
device
Product Code
FYA
Product Description
Cardinal Health Poly Reinforced Surgical Gown. Product code: FYA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
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 Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253243" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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