nPro 99+ Surgical Mask, Berry Compliant

FDA UDI

Class II (US FDA UDI)

by Np Medical

Identity

Trade Name: nPro 99+ Surgical Mask, Berry Compliant FDA UDI
Generic Name: Surgical/medical face mask, single-use FDA UDI
Device Name: The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex. FDA UDI
Model / Reference: 6412107 FDA UDI
Description: The nPro single use, disposable surgical masks provide excellent protection and are designed to meet the ASTM F2100-19 Level 1 requirements. The 3-ply pleated mask fabric can be vertically adjusted to cover the mouth and nose. The masks have an enclosed flexible nose wire and feature soft and strong ear-loops to ensure a snug and comfortable fit. All materials are not made with natural rubber latex. FDA UDI

Identifiers

Catalog Number: 6412107 FDA UDI
Primary DI / UDI-DI: 00860004362913 FDA UDI
510(k) Number: K203265 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

FDA UDI

Dimensions & Sizes

Size: Length — 17.5 Centimeter FDA UDI
Width — 9.5 Centimeter FDA UDI

Category: Surgical/medical face mask, single-use

nPro 99+ Surgical Mask, Berry Compliant by Np Medical — 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

K203265 also covers:

nPro 99+ Surgical Mask — NP MEDICAL

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: Np Medical

Sources (1)

FDA UDI 61db568a-19b2-4dac-b3fe-8292d192ba62 38 fields · synced Jun 8, 2026