(149 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 Jiangsu Province Jianerkang Medical Dressing 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 allows the user to fit the face mask around their nose, which is made from steel wire. It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled. The product is level 1 according to ASTM F2100-19.
The document describes the acceptance criteria and performance data for a Medical Face Mask (K202061).
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (ASTM F2100-19 Level 1 unless otherwise specified) | Reported Device Performance |
|---|---|---|
| Flammability | Class 1 | Class 1 (Pass) |
| Bacterial Filtration Efficiency (BFE) | ≥95% (as per device description, Level 1) | Average 99.8% (Reported as Level 3 performance) |
| Differential Pressure (Delta P) | <5.0 mm H₂O/cm² (as stated in product parameters, Level 1) | Average 3.9 mm H₂O/cm² (Reported as Level 3 performance) |
| Sub-Micron (Particulate) Filtration Efficiency | ≥95% (as per device description, Level 1) | Average 96.09% (Reported as Level 1 performance) |
| Resistance to Penetration by Synthetic Blood | 80 mmHg (as per device description, Level 1) | 160 mmHg (Reported as Level 3 performance, indicating it passed Level 1 and higher levels) |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Non-cytotoxic (Pass) |
| Biocompatibility - Irritation | Non-irritating | Non-irritating (Pass) |
| Biocompatibility - Sensitization | Non-sensitizing | Non-sensitizing (Pass) |
Note: While the device is classified as Level 1 according to ASTM F2100-19 in the device description, the performance data often reports results that meet Level 3 criteria, indicating a higher performance than the minimum required for Level 1 for those specific tests.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for each performance or biocompatibility test.
- The data provenance is from Jiangsu Province Jianerkang Medical Dressing Co., Ltd. in China. The data is retrospective, collected during the device's development and testing to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes performance testing for a medical face mask, not an AI/ML-based diagnostic device requiring expert interpretation for ground truth. The acceptance criteria are based on established international and national standards (ASTM, ISO, CFR).
4. Adjudication method for the test set:
- This information is not applicable for the same reason as point 3. Testing is based on objective, standardized laboratory methods rather than subjective expert adjudication.
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:
- This information is not applicable. The device is a medical face mask, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a medical face mask, not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" for the device's performance is established by adherence to internationally recognized standards and test methods. For example, Flammability is tested per ASTM F2100-19 and 16 CFR Part 1610-2008. BFE is tested per ASTM F2101-2019. Biocompatibility is tested per ISO 10993 series. These standards define the objective measurements and criteria for performance.
8. The sample size for the training set:
- This information is not applicable. The device is a physical medical face mask, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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December 23, 2020
Jiangsu Province Jianerkang Medical Dressing Co., Ltd Hongfang Tang Quality System Director No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town, Jintan Changzhou, Jiangsu 213251 China
Re: K202061
Trade/Device Name: Medical Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 4, 2020 Received: November 12, 2020
Dear Hongfang Tang:
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.
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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.
CAPT Elizabeth Claverie, M.S. 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) K202061
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
Jiangsu Province Jianerkang Medical Dressing Co., Ltd. Jianerkang Road, Zhixi Industry Concentration Area, ZhixiTown,213251 Jintan No.1 Changzhou City, PEOPLE'S REPUBLIC OF CHINA. Phone: +86-13585416869
Fax: +86-519-8244 4628
| Primary Contact | Hongfang Tang |
|---|---|
| Person: | Quality System Director |
| Jiangsu Province Jianerkang Medical Dressing Co., Ltd | |
| Tel: (+86)-519-8244 4628 | |
| Fax: (+86) -519-8244 4745 |
Date prepared December 22th, 2020
-
- DEVICE
| Device Name: | Medical Face mask |
|---|---|
| Common name: | Mask, Surgical |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | 2 |
| Product Code: | FXX |
PREDICATE DEVICE 3.
K160269, Surgical Face Masks (Ear loops and Tie-on) This predicate has not been subject to a design-related recall.
-
- DEVICE DESCRIPTION
The medical face mask is designed and manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. It is non-sterile and for single use.
- DEVICE DESCRIPTION
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 allows the user to fitthe
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face mask around their nose, which is made from steel wire.
It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled.
The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- י Bacterial filtration efficiency (BFE) ≥95%
- . Sub-micron particle filtration efficiency ≥95%
- . Different pressure: <5.0 mm H₂O/cm²
- . Flammability: class 1
- . 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 | Jiangsu Province JianerkangMedical Dressing Co., Ltd | SAN-M PACKAGE CO., LTD. | NA |
| 510K Number | K202061 | K160269 | NA |
| ProductCommonName | Medical face mask | Surgical Face Masks (Earloops and Tie-on) | NA |
| K202061 | |||
| 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 masksare intended to be wornto protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids. Thisis a single-use, disposabledevice, providednon-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop | Earloop or tie-on | Similar |
| Material of outerfacing layer | Polypropylene | Polypropylene | Same |
| Material of middlelayer | Melt blown polypropylene | Polypropylene meltblownand polypropylenespunbond | Similar |
| Material of innerfacing layer | Polypropylene | Polypropylene | Same |
| Nosepiece | Polypropylene coated steel wire | Polypropylene coatedsteel wire | Same |
| Attachment | Ear loops: Spandex and nylon | Ear loops: Polyester,polyurethaneSide tapes: Polyesterspunbond (ear loopsmaskonly)Tie tapes: Polypropylenespunbond or polyesterspunbond | Similar |
| 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 F 2100level | Level 1 | Level 1Level 2Level 3 | Similar |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, the proposed deviceextract was determined to benon-cytotoxic. | Under the conditions ofthe study, the proposeddevice extract wasdetermined to be non-cytotoxic. | Same |
| Irritation | Under the conditions of thestudy, the proposed deviceextract was determined to benon-irritating. | Under the conditions ofthe study, the proposeddevice extract wasdetermined to be non-irritating. | Same |
| Sensitization | Under the conditions of thestudy, the proposed deviceextract was determined to benon-sensitizing. | Under the conditions ofthe study, the proposeddevice extract wasdetermined to be 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. PERFORMANCE 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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parameters met the predefined acceptance criteria.
| Item | Test Methods | Result value | Level |
|---|---|---|---|
| Flammability | ASTM F2100-1916 CFR Part 1610-2008 | NA | Class 1 |
| Bacterial FiltrationEfficiency | ASTM F2100-2019 9.1ASTM F2101-2019 | Average 99.8% | Level 3 |
| Different Pressure,mm H2O/cm² | ASTM F2100-19 9.2 | Average 3.9 | Level 3 |
| Sub-Micron ParticleFiltration Efficiency | ASTM F2100-2019 9.3ASTM F2299/F2299M-2017 | Average 96.09% | Level 1 |
| Resistance to Penetrationby Synthetic Blood(mmHg) | ASTM F2100-2019 9.4ASTM F1862/F1862-2017 | 160 | Level 3 |
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.
From the results of non-clinical data including the performance testing described, Jiangsu Province Jianerkang Medical Dressing Co., Ltd concludes that the 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.