Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical
Summary
Hubei Xinxin Non-Woven Co., Ltd. received 510(k) clearance for Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025), a FYA device. Cleared on 2026-04-20.
Details
Source
510(k) Clearance
External ID
K253003
Action Date
2026-04-20
Status
Traditional
Category
device
Product Code
FYA
Product Description
Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025). Product code: FYA.
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. Hubei Xinxin Non-Woven Co., Ltd. has received 4 total clearances in our database.
Hubei Xinxin Non-Woven Co., Ltd. has 4 FDA actions in our database, including 4 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 Hubei Xinxin Non-Woven Co., Ltd. have FDA actions?
Hubei Xinxin Non-Woven Co., Ltd. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253003" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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