(34 days)
Not Found
No
The description focuses on the physical materials and performance characteristics of a standard surgical face mask, with no mention of AI or ML.
No
The device is described as protecting healthcare workers from microorganisms, body fluids, and particulate material, and its performance studies relate to filtration efficiency and fluid resistance, not to treating or alleviating any medical condition.
No.
The device is a face mask intended to protect users from microorganisms and body fluids, not to diagnose medical conditions.
No
The device description clearly outlines physical components (layers of polypropylene, ear loops, nose piece) and performance studies relate to material properties and filtration, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a face mask intended to protect healthcare workers from the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Testing on Samples: The device description and intended use do not involve collecting or analyzing samples from the human body.
- Performance Studies: The performance studies listed (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability) are all related to the physical properties and barrier function of the mask, not diagnostic testing.
This device falls under the category of personal protective equipment (PPE) and is regulated as a medical device, but not as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When properly worn, the Ear-Friendly Masks are intended to protect and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Ear-Friendly Masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Biocompatibility Testing:
- In vitro Cytotoxicity (ISO 10993-5): under the conditions of the test, the device was non-cytotoxic.
- Sin Sensitization (ISO 10993-10): under the conditions of the test, the device was non-sensitizing.
- Skin Irritation (ISO 10993-10): under the conditions of the device was non- irritating.
- Performance testing - Bench (according to ASTM F2100 and standards which comprise ASTM F2100):
- Fluid Resistance (ASTM F1862): Pass at 160 mmHg.
- Particle Filtration Efficiency(PFE) (ASTM F2299): Pass at ≥ 98%.
- Bacterial Filtration Efficiency(BFE) (ASTM F2101): Pass at ≥ 98%.
- Differential Pressure (MIL-M-36954C): Pass at
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue.
March 8, 2022
Ray Co., Ltd. % Rafael Aguila Responsible Third Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155
Re: K211105
Trade/Device Name: Ear-Friendly Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX
Dear Rafael Aguila:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 17, 2021. Specifically, FDA is updating this SE Letter for an incorrect date as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, PhD., OHT4: Office of Surgical and Infection Control Devices, 301-796-0270, clarence.murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
For Clarence W. Murray III, PhD. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical And Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a lighter blue next to it.
May 17, 2017
Ray Co., Ltd. % Rafael Aguila Responsible Third Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155
Re: K211105
Trade/Device Name: Ear-Friendly Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 4, 2021 Received: May 6, 2021
Dear Rafael Aguila:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian -S
For Ryan Ortega, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K211105
Device Name Ear-Friendly Mask
Indications for Use (Describe)
When properly worn, the Ear-Friendly Masks are intended to protect and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K211105 510(k) Summary
1. 510(k) Summary
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
| 2. Date: | May 14, 2021 |
|---|---|
| 3. 510(K) Number: | K211105 |
| 4. Administrative Information | |
| Sponsor Information | RAY Co.,Ltd |
| ADDRESS | 38, Simin-daero, Manan-gu, Anyang-si, Gyeonggi-do, 14098, Korea |
| Manufacturer | RAY Co.,Ltd |
| 38, Simin-daero, Manan-gu, Anyang-si, Gyeonggi-do, 14098, Korea | |
| TEL : +82-31-605-1000 | |
| FAX : +82-2-6280-5534 | |
| Contact Person | Changhwan Lee |
| Title : RA Manager | |
| Phone: +82-31-605-1000 | |
| Fax: +82-2-6280-5534 | |
| e-mail : ch0406.lee@raymedical.co.kr |
5. Device Information
Device Name
Trade/Proprietary Name: Ear-Friendly Mask Common Name: Surgical Face Mask
Classification
Classification Name: Surgical Face Mask Regulation Number : 21 CFR 878.4040 Class : Il Product code : FXX Panel : General and Plastic Surgery
6. Predicate device
| Parameter | Predicate Device |
|---|---|
| ----------- | ------------------ |
5
| Device Name | Avianz® Surgical Face Mask |
|---|---|
| Manufacturer | MEXPO INTERNATIONAL INC |
| 510(K) Number | K200847 |
| Classification name | Surgical Face Mask |
| Regulation number | 878.4040 |
| Primary product code | FXX |
7. Device Description
The Ear-Friendly Masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
8. Indication for use
When properly worn, the Ear-Friendly Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.
9. Comparison of Technological Characteristics with Predicate Device
A summary of the technological characteristics of the subject device as compared to the predicate device is listed below in Table.
| Parameter | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | MEXPO | |
| INTERNATIONAL INC | - | ||
| Device name | Ear-Friendly Mask | Avianz® Surgical Face | |
| Mask | - | ||
| 510(K) Number | K211105 | K200847 | |
| (Traditional) | - | ||
| Common | |||
| Name | Surgical Apparel | Surgical Apparel | Same |
| Indications | |||
| for use | When properly worn, the | ||
| Ear-Friendly Masks are | |||
| intended to protect both | |||
| patient and healthcare | |||
| workers from transfer of | |||
| microorganisms, body | |||
| fluids and particulate | |||
| material. This device is | |||
| non sterile and for single | |||
| use only. | When properly worn, the | ||
| surgical face masks are | |||
| intended to protect both | |||
| patient and healthcare | |||
| workers from transfer of | |||
| microorganisms, body | |||
| fluids and airborne | |||
| particles. This device is | |||
| non-sterile and for single | |||
| use only. | Similar | ||
| Note 1 | |||
| Materials | |||
| Outer Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown Polypropylene Filter | Melt Blown Polypropylene Filter | Same |
| Inner Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanize wire, coated By PE | Single Galvanize wire, coated By PE | Same |
| Ear Loops | Elastic non-woven Fabric (Made With PE&PP mixed) | not made with natural rubber latex | Similar Note2. |
| Design Features | |||
| Color | White | White | Same |
| Style | 3 Ply, Ear Loops, Flat-Pleated Style | 3 Ply, Ear Loops, Flat-Pleated Style | Same |
| Dimension(Width) | $95mm \pm 10mm$ | $90 mm \pm 5mm$ | Similar Note3 |
| Dimension(Length) | $175mm \pm 10mm$ | $175 mm \pm 5mm$ | Similar Note3 |
| Single Use | Yes | Yes | Same |
| Sterility | |||
| Sterile | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the studies, the subject device is non-cytotoxic | Under the conditions of the studies, the subject device is non-cytotoxic | Same |
| Sensitization | Under the conditions of the studies, the subject device is non-sensitizing | Under the conditions of the studies, the subject device is non-sensitizing | Same |
| Irritation | Under the conditions of the studies, the subject device is non-irritating | Under the conditions of the studies, the subject device is non-irritating | Same |
| Non-clinical Tests Performed on the device | |||
| ASTM Level | Level 3 | Level 2 | Different (Note 1) |
| Bacterial Filtration Efficiency(BFE) | Pass at ≥98% | Pass at ≥98% | Same |
| Particle Filtration Efficiency(PFE) | Pass at ≥98% @ 0.1 micron | Pass at ≥98% @ 0.1 micron | Same |
| Synthetic Blood Penetration | Passed at 160mm Hg | Passed at 120mm Hg | Different |
| Differential Pressure Only | Pass at $ |