Standard Procedure Mask

FDA UDI

Class II (US FDA UDI)

by JiangSu MedPlus Non-Woven Manufacturer Co., Ltd

Identity

Trade Name: Standard Procedure Mask FDA UDI
Generic Name: Surgical/medical face mask, single-use FDA UDI
Device Name: Mask color: White FDA UDI
Model / Reference: Elastic ear-loop FDA UDI
Description: Mask color: White FDA UDI

Identifiers

Primary DI / UDI-DI: 06971705242702 FDA UDI
510(k) Number: K202605 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: Surgical/medical 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical/medical face mask, single-use

Standard Procedure Mask by JiangSu MedPlus Non-Woven Manufacturer Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, single-use.

ProGear — Prestige Ameritech · Class II
Precept® — Precept Medical Products, Inc. · Class II
hcs — DYAD MEDICAL SOURCING, LLC · Class I
Precept® — Precept Medical Products, Inc. · Class II
AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Surgical Face Mask — Foshan Nanhai Plus Medical Co., Ltd · Class II

Cleared under the same submission

K202605 also covers:

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

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Manufacturer

Manufacturer: JiangSu MedPlus Non-Woven Manufacturer Co., Ltd

Sources (1)

FDA UDI 8c06ec60-184f-4112-9978-ff72f9fffcd5 34 fields · synced May 30, 2026