(90 days)
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose. The product is level 1 according to ASTM F2100-19.
This document describes the premarket notification (510(k)) for a Medical Face Mask, focusing on its substantial equivalence to a legally marketed predicate device. The information provided is for a physical medical device (a face mask) and not an AI/ML-driven device. Therefore, many of the requested details about AI model performance, training sets, ground truth establishment by experts, adjudication, and MRMC studies are not applicable to this document.
However, I can extract and present the acceptance criteria and the study results for this specific medical device.
Device: Medical Face Mask (K212471)
Predicate Device: Surgical Face Masks (Ear loops and Tie-on) (K160269)
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are "Pass" for all tests, with specific quantitative thresholds where applicable. The reported device performance is that all tests met these criteria.
| Item | Test Methods | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Flammability | ASTM F2100-19, 16 CFR Part 1610-2008 | Class 1 | Pass |
| Bacterial Filtration Efficiency (BFE) | ASTM F2100-2019 9.1, ASTM F2101-2019 | ≥95% | Pass |
| Differential Pressure | ASTM F2100-19 9.2 | < 5.0 mm H₂O/cm² | Pass |
| Sub-Micron Particle Filtration Efficiency | ASTM F2100-2019 9.3, ASTM F2299/F2299M-2017 | ≥95% | Pass |
| Resistance to Penetration by Synthetic Blood | ASTM F2100-2019 9.4, ASTM F1862/F1862-2017 | Pass at 80 mmHg | Pass |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5: 2009 | Non-cytotoxic | Non-cytotoxic |
| Sensitization | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing |
| Skin Irritation | ISO 10993-10:2010 | Non-irritating | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of masks) used for each specific performance or biocompatibility test. It mentions that "All of the tested parameters met the predefined acceptance criteria," implying that a sufficient number of samples were tested to demonstrate compliance.
The data provenance is implied to be from testing conducted by Haian Medigauze Co., Ltd. in China, as they are the submitter. The data is retrospective, as it's being submitted for premarket notification of a completed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as this is a physical medical device (face mask) and not an AI/ML-driven device that requires expert ground truth for its performance evaluation (e.g., image interpretation). The "ground truth" for the face mask is established by validated laboratory test methods and established international standards (ASTM, ISO).
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as #3. Performance is determined by objective, measurable laboratory tests, not by human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This question is not applicable as this is not an AI-assisted diagnostic device or a device where human reader performance is a relevant metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as this is not an AI/ML algorithm. The "standalone" performance refers to the intrinsic physical properties and filtration capabilities of the face mask itself, as measured by standard laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective laboratory measurements against predefined performance standards (e.g., ASTM F2100-19 for filtration efficiency, differential pressure, flammability, and resistance to synthetic blood penetration; ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing ground truth for this type of device.
8. The Sample Size for the Training Set
This question is not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" process with a dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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November 4, 2021
Haian Medigauze Co., Ltd Weihua Xu General Manager Jiaoxie Industry Park, Haian Nantong, Jiangsu 226633 China
Re: K212471
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 30, 2021 Received: August 6, 2021
Dear Weihua Xu:
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
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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,
For Clarence W. Murray, III, Ph.D. 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
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Indications for Use
510(k) Number (if known) K212471
Device Name Medical face mask
Indications for Use (Describe)
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
| 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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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
- SUBMITTER
Haian Medigauze Co., Ltd. Jiaoxie Industry Park 226633 Haian, Jiangsu, PEOPLE'S REPUBLIC OF CHINA. Phone: +86-13901478762 +86-513-88240958 Fax:
- SUBMITTER
| Primary Contact Person: | Weihua Xu |
|---|---|
| General Manager | |
| Haian Medigauze Co., Ltd. | |
| Tel: (+86) -13901478762 | |
| Fax: (+86) -513-88240958 |
Date prepared Nov 3, 2021
-
- DEVICE
| Device name: | Medical Face mask |
|---|---|
| Common name: | Mask, Surgical |
| Regulation number: | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |
3. PREDICATE DEVICE
K160269, Surgical Face Masks (Ear loops and Tie-on).
This predicate has not been subject to a design-related recall.
4. DEVICE DESCRIPTION
The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use.
The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose.
The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as follows:
- I Bacterial filtration efficiency (BFE) ≥95%
- . Sub-micron particle filtration efficiency ≥95%
- Differential pressure: <5.0 mm H₂O/cm²
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- I Flammability: class 1
- I Resistance to penetration by synthetic blood: 80 mmHg
5. INDICATIONS FOR USE
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.
| Proposed device | Predicate device | Comparisonresult | |
|---|---|---|---|
| Manufacturer | Haian Medigauze Co., Ltd | SAN-M PACKAGE CO., LTD. | NA |
| 510K Number | K212471 | K160269 | NA |
| ProductCommonName | Medical face mask | Surgical Face Masks (Earloops and Tie-on) | NA |
| Intended Use | The medical face mask isintended to be worn to protectboth the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerials in infection controlpractices to reduce thepotential exposure to bloodand body fluids. It is for single-use and provided non-sterile. | The surgical face masks areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single-use,disposable device, providednon-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Designfeature | Ear loop | Earloop or tie-on | Similar |
| Material ofouter facinglayer | Polypropylene | Polypropylene | Same |
| Material ofmiddle layer | Melt blown polypropylene | Polypropylene meltblownand polypropylene spunbond | Similar |
| Material ofinner facinglayer | Polypropylene | Polypropylene | Same |
| Nosepiece | Polypropylene coated steelwire | Polypropylene coated steelwire | Same |
| Attachment | Ear loops: Spandex and nylon | Ear loops: Polyester,polyurethaneSide tapes: Polyesterspunbond (ear loops mask) | Similar |
| K212471 | |||
| only)Tie tapes: Polypropylenespunbond or polyesterspunbond | |||
| Color | Blue | Blue, White | Similar |
| Dimension(Length ×Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm18.0 cm × 9.0 cm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F2100level | Level 1 | Level 1 | Same |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, the proposed deviceextract was determined to benon-cytotoxic. | Under the conditions of thestudy, the proposed deviceextract was determined tobe non-cytotoxic. | Same |
| Irritation | Under the conditions of thestudy, the proposed deviceextract was determined to benon-irritating. | Under the conditions of thestudy, the proposed deviceextract was determined tobe non-irritating. | Same |
| Sensitization | Under the conditions of thestudy, the proposed deviceextract was determined to benon-sensitizing. | Under the conditions of thestudy, the proposed deviceextract was determined tobe non-sensitizing. | Same |
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The subject device is the same as the predicate device in the intended use, material, ASTM F2100 level and biocompatibility, and similar in mask style, design feature and dimension. So the subject device is similar to the predicate device.
7. PERFORMANČE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the medical face mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity - (ISO 10993-5: 2009)
- Sensitization - (ISO 10993-10:2010)
- Skin Irritation - (ISO 10993-10:2010)
Performance testing
Performance testing was conducted on the medical face mask. All of the tested
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| Item | Test Methods | Criterion | Result |
|---|---|---|---|
| Flammability | ASTM F2100-1916 CFR Part 1610-2008 | Class 1 | Pass |
| Bacterial FiltrationEfficiency | ASTM F2100-2019 9.1 ASTMF2101-2019 | ≥95% | Pass |
| Different Pressure | ASTM F2100-19 9.2 | < 5.0 mm H2O/cm² | Pass |
| Sub-Micron ParticleFiltration Efficiency | ASTM F2100-2019 9.3ASTM F2299/F2299M-2017 | ≥95% | Pass |
| Resistance toPenetration bySynthetic Blood | ASTM F2100-2019 9.4 ASTMF1862/F1862-2017 | Pass at 80 mmHg | Pass |
parameters met the predefined acceptance criteria.
8. CLINICAL DATA
No clinical data was included in this submission.
9. CONCLUSION
The indications for use statement for the subject device is similar to that of the predicate. The differences between the medical face mask and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the medical face mask should perform as intended in the specified use conditions.
The conclusions drawn from the nonclinical testing demonstrate that the subject device, the Haian Medigauze Medical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed as the predicate device (K160269).
§ 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.