Surgical Apparel Accessory

FDA UDI

Class I (US FDA UDI)

by Hangzhou A-Tek Medical & Textiles Co., Ltd.

Identity

Trade Name: SURGICAL APPAREL ACCESSORY FDA UDI
Generic Name: Public face mask, single-use FDA UDI
Device Name: SURGICAL APPAREL ACCESSORY, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS FDA UDI
Model / Reference: 28023 FDA UDI
Description: SURGICAL APPAREL ACCESSORY, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS FDA UDI

Identifiers

Primary DI / UDI-DI: 06950471300069 FDA UDI
FDA Product Code: LYU FDA UDI
GMDN Term: Public face mask, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Public face mask, single-use

Surgical Apparel Accessory by Hangzhou A-Tek Medical & Textiles Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Public face mask, single-use.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hangzhou A-Tek Medical & Textiles Co., Ltd.

Sources (1)

FDA UDI 547cbdba-6207-46c9-abd2-c9132fd4c6e2 33 fields · synced May 30, 2026