N P Medical Inc.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (2)

Premarket Exempt

Clear

nPro 99+ Surgical Mask - 00860004362906 Catalog Number : 6409996

Device Description : The nPro single use, disposable surgical masks provide excellent protection and 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.

Device Class : 2

Duns Number: 118211010

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

nPro 99+ Surgical Mask, Berry Compliant - 00860004362913 Catalog Number : 6412107