(63 days)
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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.
The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear. The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering. This is a single use, disposable device(s), provided non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets those criteria, specifically concerning AI/ML performance metrics, multi-reader multi-case studies, effect size of human readers improving with AI, standalone algorithm performance, and ground truth establishment/training sets, are not applicable.
However, I can extract the acceptance criteria and reported device performance for this medical face mask from the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Discussion |
|---|---|---|---|
| Particulate Filtration Efficiency | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.68%, Lot 2: 99.56%, Lot 3: 99.81% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.926%, Lot 2: 99.93%, Lot 3: 99.936% | Similar (Subject device performance meets or exceeds predicate) |
| Bacterial Filtration Efficiency (BFE) | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.9%, Lot 2: 99.9%, Lot 3: 99.9% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: ≥99%, Lot 2: ≥99%, Lot 3: ≥99% | Similar (Subject device performance meets criteria, although specific values for predicate are higher than the "≥99%" reported for the subject) |
| Differential Pressure | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 3.8 mm H2O/cm², Lot 2: 3.6 mm H2O/cm², Lot 3: 3.7 mm H2O/cm² | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: <5 mm H2O/cm², Lot 2: <5 mm H2O/cm², Lot 3: <5 mm H2O/cm². (Note: Specific values are also provided: Lot 1: 3.9 mm H2O/cm², Lot 2: 4.1 mm H2O/cm², Lot 3: 4.2 mm H2O/cm² based on the raw data in the table, but the general criterion is <5 mm H2O/cm²) | Similar (Subject device performance meets the <5 mm H2O/cm² criterion) |
| Flammability | Class 1, 3 non-consecutive lots tested, using a sample size of 32/lot. | Class 1, 3 non-consecutive lots tested, using a sample size of 32/lot. | Identical |
| Fluid Resistance | 32 out of 32 per lot pass at 120 mmHg, 3 non-consecutive lots tested. | Pass at 120 mmHg | Similar (Implies similar passing rate based on the "pass" result, though specific sample size/pass numbers from the subject device are not explicitly listed in the comparison table, only for the predicate.) |
| Biocompatibility | ISO 10993-5 and ISO10993-10; device extract non-cytotoxic, non-sensitizing, and non-irritating | ISO 10993-5 and ISO10993-10; device extract non-cytotoxic, non-sensitizing, and non-irritating | Identical |
2. Sample size used for the test set and the data provenance:
- For Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability: 3 non-consecutive lots were tested, with a sample size of 32 per lot.
- For Fluid Resistance: The predicate device had 32 out of 32 per lot passing. The subject device simply states "pass at 120 mmHg," implying similar testing was conducted.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were non-clinical, conducted by Hubei Mediunion Medical Products Co., Ltd. for their proposed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These are objective physical and biological performance tests for a medical face mask, not expert-adjudicated diagnoses or interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. These are objective physical and biological performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Test Standards: The "ground truth" or acceptance criteria are based on established international and national standards for medical face mask performance, such as ASTM F1862, ASTM F2101, ASTM F2100, EN 14683, ISO 10993-5, ISO 10993-10, and 16 CFR Part 1610. The device's performance is measured directly against these standard specifications.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device; there is no "training set."
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Image /page/0/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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 26, 2022
Hubei Mediunion Medical Products Co., Ltd. Jason Sheen Vice President No.1 ChuangYe Road, Zhongling Industrial Zone, Pengchang Town Xiantao. Hubei 433000 China
Re: K220487
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 9, 2022 Received: February 22, 2022
Dear Jason Sheen:
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
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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 medical devices and radiation-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 L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220487
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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.
| 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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Section 3-510(k) summary
I Submitter
| Device submitter: Hubei Mediunion Medical Products Co., Ltd. |
|---|
| No.1 Chuang Ye Road, Zhongling Industrial Zone, Pengchang Town |
| Xiantao city, Hubei province, China |
- Contact person: Jason Sheen Vice President Phone: 0086-574-27882323 E-mail: jason@cehcare.com Date Prepared: April 25, 2022
II Proposed Device
| Trade/Device Name: | Disposable medical face mask |
|---|---|
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Regulatory Class: | Class II |
| Product code: | FXX |
III Predicate Devices
| 510(k) Number: | K202211 |
|---|---|
| Trade/Device Name: | Disposable Medical Surgical Face Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | Guangdong Kaidi Garments Co.,Ltd |
IV Device description
The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear.
The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering.
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This is a single use, disposable device(s), provided non-sterile.
V Indication for use
The Disposable Medical 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 Disposable medical 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.
VI Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
- A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- A 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)
- A ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- A ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- EN 14683: 2019. Annex C. Medical face masks- Requirements and test methods >
- A ISO 10993-5:2012 Biological evaluation of medical device- Part 12: Sample preparation and reference materials
- A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
VII Clinical Test Conclusion
No clinical study is included in this submission.
VIII Summary of Technological characteristics
Table 1 Comparison of Disposable Medical face Mask
| Item | Subject device | Predicate device | Discussion | |
|---|---|---|---|---|
| Product name | Disposable medical facemask | Disposable MedicalSurgical Face Masks | NA | |
| 510K number | K202211 | NA | ||
| Product Code | FXX | FXX | identical | |
| Intended use | The Disposable MedicalFace Mask is intended tobe worn to protect both the | The disposable medicalsurgical face masks are | identical | |
| patient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. The DisposableMedical Face Mask isintended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice(s), providednon-sterile. | intended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms,bodyfluids and particulatematerial.These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids.This is a singleuse,disposabledevice(s),providenon-sterile. | |||
| ASTM F2100Level | Level 2 | Level 2 | identical | |
| Design feature | ear loop or tie-on | ear loop | Similar | |
| Color | Blue | Blue | identical | |
| Dimension | 175mmx95mm | 175mmx95mm | identical | |
| Sterility | Non-Sterile | Non-Sterile | identical | |
| Use | Single Use, Disposable | Single Use, Disposable | identical | |
| Particulatefiltrationefficiency | 3 non-consecutive lotstested, using a sample sizeof 32/lot.Lot 1: 99.926%Lot 2: 99.93%Lot 3: 99.936% | 3 non-consecutive lotstested, using a sample sizeof 32/lot.Lot 1: 99.68%Lot 2: 99.56%Lot 3: 99.81% | Similar | |
| Bacterial filtrationefficiency | 3 non-consecutive lotstested, using a sample sizeof 32/lot.Lot 1: ≥99%Lot 2: ≥99%Lot 3: ≥99% | 3 non-consecutive lotstested, using a sample sizeof 32/lot.Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9% | Similar | |
| Differential pressure | 3 non-consecutive lotstested, using a sample sizeof 32/lot. | 3 non-consecutive lotstested, using a sample sizeof 32/lot. | Similar | |
| Lot 2: <5 mm H2O/cm 2Lot 3: <5 mm H2O/cm 2 | Lot 2: 3.6 mm H2O/cm 2Lot 3: 3.7 mm H2O/cm 2 | |||
| Flammability | Class1, 3 non-consecutivelots tested, using a samplesize of 32/lot. | Class1, 3 non-consecutivelots tested, using a samplesize of 32/lot. | identical | |
| Fluid resistance | pass at 120 mmHg | 32 out of 32 per lot pass at120 mmHg, 3non-consecutive lots tested | Similar | |
| Label/Labeling | Complied with 21 CFRpart 801 | Complied with 21 CFRpart 801 | identical | |
| Patient Contacting Material | Inner andOuter layers | Spunbond polypropylene | Spun-bond nonwovenfabric | Different |
| Middle layer | Meltblown polypropylene | Melt blown non-wovenfabric | Different | |
| Nose clip | Iron wire covered with PPcovering or aluminumwire covered with PPcovering | PE and iron wire | Different | |
| Ear loops | Urethane elastic fiber orspunbond polypropylene | Nylon and Spandex | Different | |
| Biocompatibility | ISO 10993-5 andISO10993-10;Under the conditions ofthestudy, the proposeddeviceextract wasdetermined tobenon-cytotoxic,non-sensitizing,andnon-irritating | ISO 10993-5 andISO10993-10;Under the conditions ofthestudy, the proposeddeviceextract wasdetermined tobenon-cytotoxic,non-sensitizing,andnon-irritating. | identical | |
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Different - Patient Contacting Material
The patient contacting material for the proposed device is different from the two predicate devices. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
IX Conclusion
The proposed device has the same the intended use as the predicate device. It presents similar technological characteristics as the predicate device including the performance
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parameters and biocompatibility. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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.