Ear-Friendly Mask
FDA 510(k)Class II (US FDA 510(k))
by Ray Co., Ltd
Identifiers
- 510(k) Number
- K211105 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)
The Ear-Friendly Mask is a medical device designed to protect healthcare workers from the transfer of microorganisms, body fluids, and particulate material. It functions as a barrier to help maintain a sanitary environment during clinical tasks.
This device is supplied in a quantity of 50 units per package. It has received FDA 510(k) clearance under K211105 and is currently in commercial distribution.
Frequently asked questions
What is the primary purpose of the Ear-Friendly Mask?
The Ear-Friendly Mask is designed to serve as a protective barrier for healthcare workers. It helps maintain a sanitary environment by reducing the transfer of microorganisms, body fluids, and particulate material during clinical tasks.
How is the Ear-Friendly Mask supplied?
This device is supplied in a package containing 50 units. This quantity is intended to support the needs of healthcare environments requiring consistent access to protective barrier equipment.
What is the regulatory status of this device?
The Ear-Friendly Mask has received FDA 510(k) clearance under K211105. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: K211105 - Ear-Friendly Mask | FDA 510 (k) | Ray Co., Ltd., Ray Co., Ltd Ear-Friendly Mask Ear-Friendly Mask - RevMed, Ear-Friendly Mask (K211105) — FDA 510 (k) | Innolitics, AccessGUDID - DEVICE: Ear-Friendly Mask (08800003025008)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211105 | Class II | Active |
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Manufacturer
- Manufacturer
- Ray Co., Ltd
- FDA Applicant
- Ray Co., Ltd.
Sources (1)
- FDA 510(k) K211105 24 fields · synced Sep 23, 2026