Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211827

by Zhejiang Lanhine Medical Products Ltd.

Identifiers

510(k) Number: K211827 FDA 510(k)
FDA Product Code: FXX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4040 FDA 510(k)
Regulation Number: 878.4040 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a Level 3 Fluid Resistant Procedure/Surgical Mask, classified under product code FXX. It is designed to provide protection against microorganisms, body fluids, and particulate matter, ensuring barrier integrity for both patients and healthcare personnel during surgical and procedural settings.

The masks are supplied in sterile packaging for single-use and are intended for use in general and plastic surgery environments. They comply with FDA 510(k) clearance (K211827) and EU MDR regulations, with a decision of Substantially Equivalent (SESE) issued on 2021-09-23. Storage and handling must adhere to manufacturer guidelines to maintain sterility and performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F), Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F), Level 3 Fluid Resistant Procedure/Surgical Mask… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K211827	Class II	Active

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Manufacturer

Manufacturer: Zhejiang Lanhine Medical Products Ltd.
FDA Applicant: Zhejiang Lanhine Medical Products, Ltd.

Sources (2)

FDA 510(k) K211827 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 29, 2026