Reinforced Sterile Level 4 Surgical Gown GM4025

by Hubei Xinxin Non-Woven Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06973384924115 UDI-DI	Date1 Sep 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Reinforced Sterile Level 4 Surgical Gown
Generic Name: Surgical gown, single-use
Model / Reference: GM4025

Primary DI / UDI-DI: 06973384924115
FDA Product Code: FYA
GMDN Term: Surgical gown, single-use

Device Class: Class II
Regulation Number: 878.4040
GUDID distribution status: In Commercial Distribution

Other devices from Hubei Xinxin Non-Woven Co., Ltd.

Sterile Level 3 Surgical Gown M4025

Class II
AAMI4 Isolation Gown

Class II
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)

Class II
Surgical Masks

Class II
AAMI3 Isolation Gown

Class II

Properties

Sterile
Single Use
Premarket Exempt
Lot / Batch Number
Serial Number
Expiration Date
Manufacturing Date

Other properties (7)

Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No