Aok

FDA UDI

Class II (US FDA UDI)

by Aok Tooling Limited

Identity

Trade Name: AOK FDA UDI
Generic Name: Public face mask, single-use FDA UDI
Device Name: Plan Surgical Face Mask FDA UDI
Model / Reference: 20190019 FDA UDI
Description: Plan Surgical Face Mask FDA UDI

Identifiers

Primary DI / UDI-DI: 16973869540028 FDA UDI
510(k) Number: K201517 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: Public face mask, single-use FDA UDI

Classification

Device Class: Class II 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Public face mask, single-use

Aok by Aok Tooling Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Public face mask, single-use.

JMU — JMU DENTAL, INC · Class II
Child Face Masks — Dynarex Corp. · Class I
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
JMU — JMU DENTAL, INC · Class II
ZhengKang — Guangzhou Zhengkang Medical Equipment Co., Ltd · Class II
Trinity Sterile, Inc. — TRINITY STERILE, INC. · N
Halyard — O&M HALYARD, INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II

Cleared under the same submission

K201517 also covers:

AOK — Aok Tooling Limited
AOK — Aok Tooling Limited

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Aok Tooling Limited

Sources (1)

FDA UDI 4a4ad099-82da-46bb-8d42-614927d961eb 34 fields · synced Jun 8, 2026