(109 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.
No
The device is a face mask intended for infection control and protection from transfer of microorganisms and body fluids, not for treating a disease or condition.
No
Explanation: The device is a face mask intended for protection against the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly details physical components (three-layer mask, nose piece, ear loops) and materials (polypropylene, polyester, spandex, aluminum). The performance studies focus on physical properties and material biocompatibility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- Device Intended Use: The intended use of this face mask is to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It is a physical barrier used on the body.
- Lack of IVD Characteristics: The description and performance metrics provided are related to the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability), not to the analysis of biological specimens.
The information clearly indicates this is a medical device intended for personal protection and infection control, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Medical Disposable Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Medical Disposable Face Mask is blue color, single use, three-layer, flat-pleated mask with nose piece and ear loop. The blue colorant is polypropylene (PP) masterbatch.
The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of polyester and spandex, not made with natural rubber latex.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum with polypropylene (PP) covering. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
The medical face masks are available in two size specifications, 17.5×9.5cm, 14.5×9.5cm. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
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 personnel
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 tests were conducted to verify that the proposed device met all design specifications. Performance testing was carried out to verify the safety and the effectiveness of the subject device. Nonclinical functional performance testing was performed in accordance with:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F2299/F2299M-03 (R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- EN 14683:2019+AC:2019 Medical Face Masks - Requirements and Test Methods
- 16 CFR 1610 Standard for the Flammability of Clothing Textiles
Testing datas and results demonstrated that the Medical Disposable Face Mask meets all the pre-determined testing and acceptance criteria.
Biocompatibility testing was completed on the Medical Disposable Face Masks according to the following standards:
- ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation And Testing Within A Risk Management Process
- ISO 10993-5:2009-Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010-Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
The contact duration is less than 24 hours. The following tests were performed: Cytotoxicity, Irritation and Sensitization. Biocompatibility testing reports demonstrated that the device components that are in contact with the patient are biocompatible. All evaluation acceptance criteria were met.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance ASTM F1862: 32 out of 32 per lot pass at 80 mmHg, 3 non-consecutive lots tested
Particulate Filtration Efficiency ASTM F2299: ≥ 95%
Bacterial Filtration Efficiency ASTM F2101: ≥ 95%
Differential Pressure (Delta P) EN14683 Annex C:
§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
January 3, 2023
Anqing Mayfield Medical Limited Kevin Huang Official Correspondent Jingwu Road, Tongcheng Economic and Technological Development Zone Anging, Anhui 231400 China
Re: K222809
Trade/Device Name: Medical Disposable Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 26, 2022 Received: January 3, 2023
Dear Kevin Huang:
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.
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
1
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 (OS) 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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222809
Device Name Medical Disposable Face Masks
Indications for Use (Describe)
The Medical Disposable Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
| 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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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date of Preparation: September 1, 2022
1. Submitter:
510(k) Owner's Name: Anqing Mayfield Medical Limited Address: Jingwu Road, Tongcheng Economic and Technological Development Zone, Anging, Anhui, CN 231400 Contact Person: Minghan Zhou Title: General Manager Email: aqmayfield@163.com Tel: +86-18601137753 Fax: +86-556-6961888
2. Submission Correspondent:
Contact Person: Kevin Huanq Email: Kevin huang1021@Sina.com Tel: +86-13602471659 Fax: +86-20- 84558599
3. Identification of the Device
Device Name: Medical Disposable Face Masks Common Name: Face Mask, Surqical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Classification: Class II Product Code: FXX
4. Identification of the Primary Predicate Device
510(k) Number: K214087 Trade/Device Name: Medical Face Mask Common Name: Surgical Mask Manufacturer: Hubei Medlink Healthcare Co., Ltd Requlation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Classification Name: Surgical Face Mask Classification: Class II Product Code: FXX
5. Indications for Use
The Medical Disposable Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.
6. Device Description
The Medical Disposable Face Mask is blue color, single use, three-layer, flat-pleated mask with nose piece and ear loop. The blue colorant is polypropylene (PP) masterbatch.
4
The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of polyester and spandex, not made with natural rubber latex.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum with polypropylene (PP) covering. Users can adjust the nose piece according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
The medical face masks are available in two size specifications, 17.5×9.5cm, 14.5×9.5cm. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
7. Substantial Equivalence-Comparison to Predicate Devices
A side by side comparison of the proposed device and the predicate device are provided below.
| Comparison between proposed device and predicate device | ||||
|---|---|---|---|---|
| Comparison Items | Proposed Device | Predicate Device | Discussion of Differences | |
| Devece Name | Medical Disposable Face | |||
| Masks | Medical Face Mask | Similar | ||
| 510k Number | K214087 | --- | ||
| Product Code | FXX | FXX | Same | |
| Regulation | ||||
| Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Indications for | ||||
| Use | The Medical Disposable | |||
| Face Mask is intended to | ||||
| be worn to protect both the | ||||
| patient and healthcare | ||||
| personnel from transfer of | ||||
| microorganisms, body | ||||
| fluids and particulate | ||||
| material. The face mask is | ||||
| intended for use in | ||||
| infection control practices | ||||
| to reduce the potential | ||||
| exposure to blood and | ||||
| body fluids. This is a single | ||||
| use, disposable device, | ||||
| provided non-sterile. | The Medical Disposable Face | |||
| Mask is intended to be worn | ||||
| to protect both the patient and | ||||
| healthcare personnel from | ||||
| transfer of microorganisms, | ||||
| body fluids and particulate | ||||
| material. The face mask is | ||||
| intended for use in infection | ||||
| control practices to reduce | ||||
| the potential exposure to | ||||
| blood and body fluids. This is | ||||
| a single use, disposable | ||||
| device(s), provided non- | ||||
| sterile. | Same | |||
| Size | ||||
| specification | ||||
| (Dimension) | 17.5×9.5cm | |||
| 14.5×9.5cm | 17.5×9.5cm | |||
| 16×9.5cm | ||||
| 15.5×9.5cm | ||||
| 14.5×9.5cm | ||||
| 14×9.5cm | Similar. | |||
| The proposed device's | ||||
| sizes are included within | ||||
| the size range of the | ||||
| predicate device which | ||||
| have been approved by | ||||
| FDA in K214087. | ||||
| Color | Blue | Blue | Same | |
| Design Feature | Ear Loops, Flat-pleated, 3 | |||
| layers | Ear Loops, Flat-pleated, 3 | |||
| layers | Same | |||
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| Materials | Outer layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Inner layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | |
| Middle layer | ||||
| (Filter layer) | Melt-blown Polypropylene | Melt-blown Polypropylene | Same | |
| Nose piece | Aluminum with | |||
| Polypropylene (PP) | ||||
| covering | Malleable polyethylene wire | Different. | ||
| The proposed device has | ||||
| different material of nose | ||||
| piece and ear loop to the | ||||
| predicate | ||||
| device, | ||||
| the | ||||
| biocompatibility test has | ||||
| been conducted on the | ||||
| final finished device and | ||||
| test results show that the | ||||
| proposed device can meet | ||||
| the requirements of ISO |
- Therefore,
the
differences
in
the
materials don't raise any
additional questions for
safety and effectiveness. |
| | Ear loop | Polyester, Spandex | Spandex | |
| | OTC use | Yes | Yes | Same |
| | Sterility | Non-Sterile | Non-Sterile | Same |
| | ASTM F2100
Level | Level 1 | Level 1 | Same |
| | Fluid Resistance
Performance
ASTM F1862 | 32 out of 32 per lot pass at
80 mmHg, 3 non-
consecutive lots tested | 32 out of 32 per lot pass at 80
mmHg, 3 non-consecutive
lots tested | Same |
| | Particulate
Filtration
Efficiency
ASTM F2299 | ≥ 95% | ≥ 95% | Same |
| | Bacterial Filtration
Efficiency
ASTM F2101 | ≥ 95% | ≥ 95% | Same |
| | Differential
Pressure
(Delta P)
EN14683 Annex C | ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) > ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus > ASTM F2299/F2299M-03 (R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
EN 14683:2019+AC:2019 Medical Face Masks - Requirements and Test Methods
16 CFR 1610 Standard for the Flammability of Clothing Textiles
Testing datas and results are included in this submission, and demonstrated that the Medical Disposable Face Mask meets all the pre-determined testing and acceptance criteria.
2) Biocompatibility
The contact duration of the proposed device Medical Disposable Face Mask is less than 24 hours. According to ISO 10993-1:2018 Annex A Table A.1 and FDA Biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" published on June 16, 2016, the Medical Disposable Face Mask is considered a Surface Device that comes in contact with the Skin for limited exposure (