(316 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard medical face mask, with no mention of AI or ML.
No
The device is a medical face mask, intended to prevent the transfer of microorganisms and particulate materials; it does not aim to treat or cure a disease or condition.
No
The device is a medical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate materials; it performs no diagnostic function.
No
The device description clearly indicates it is a physical medical face mask made of materials like polypropylene, not software. The performance studies are also related to the physical properties of the mask.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect users from the transfer of microorganisms, body fluids, and particulate materials. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of a face mask.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health, disease state, or condition.
- Performance Studies: The performance studies focus on the physical and biological barrier properties of the mask (filtration efficiency, fluid resistance, biocompatibility), not on diagnostic accuracy or analytical performance related to detecting specific substances or conditions.
IVD devices are specifically designed to perform tests in vitro (outside the body) on specimens derived from the human body to provide diagnostic information. This face mask does not fit that description.
N/A
Intended Use / Indications for Use
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. 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 medical face masks are 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 spun-bond 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.
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)
Medical face mask has been evaluated the safety and performance by lab bench testing according to the following standards:
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
Biocompatibility testing:
- ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Summary of Performance Testing:
- Fluid Resistance Performance (ASTM F1862): Lot 1: 32 Out of 32 pass at 120 mmHg; Lot 2: 32 Out of 32 pass at 120 mmHg; Lot 3: 32 Out of 32 pass at 120 mmHg. Acceptance Criteria: 29 Out of 32 pass at 120 mmHg. Result: Pass.
- Particulate Filtration Efficiency (ASTM F2299): Lot 1: 98.9%; Lot 2: 98.9 %; Lot 3: 98.7 %. Acceptance Criteria: ≥ 98%. Result: Pass.
- Bacterial Filtration Efficiency (ASTM F2101): Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9%. Acceptance Criteria: ≥ 98%. Result: Pass.
- Flammability (16 CFR 1610): Lot 1: Class 1; Lot 2: Class 1; Lot 3: Class 1. Acceptance Criteria: Class 1. Result: Pass.
- Differential Pressure (EN 14683:2019): Lot 1: 3.0 mmH2 0/cm²; Lot 2: 3.1 mmH2 0/cm²; Lot 3: 3.3 mmH2 0/cm². Acceptance Criteria:
§ 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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January 18, 2022
Wuxi Yushou Medical Appliances Co.,Ltd. Xiaoling Dai QA&QC Manager No.115 Nongxinhe Road, Xishan District, Wuxi City, Jiangsu Province, China. Wuxi, Jiangsu 214200 China
Re: K210679
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 9, 2021 Received: January 10, 2022
Dear Xiaoling Dai:
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
1
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210679
Device Name Medical face mask
Indications for Use (Describe)
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
| Type of Use (Select one or both, as applicable) | Demonstration Use (Ref 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C) | Demonstration Use (Ref 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|---|---|
| Demonstration Use (Ref 21 CFR 201 Subpart D) | |||
| Over-The-Counter Use (21 CFR 201 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Submission number: K210679
510(k) Summary
Submitter Information 1.
Company Name:Wuxi Yushou Medical Appliances Co.,Ltd.
Address: No.115 Nongxinhe Road, Xishan District, Wuxi City, Jiangsu Province, China.
Phone:+86-510-83777555
Contact Person (including title): Xiaoling Dai (QA&QC Manager)
E-mail : Kiwi-xu@isosh.com
Subject Device Information
- Traditional Type of 510(k):
- Common Name: Surgical face mask
- Trade Name: Medical face mask
- Classification Name: Mask,Surgical
- Review Panel: General Hospital
- Product Code: FXX
- Regulation Number: 21 CFR 878.4040
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- Regulation Class:
2. Predicate Device Information
- Sponsor: MEXPO INTERNATIONAL INC.
- Surgical Face Mask Common Name:
- Trade Name: Surgical Face Mask
- 510(k) number: K200847
- Review Panel: General Hospital
- Product Code: FXX
- Regulation Number: 21 CFR 878.4040
- Regulation Class: Class II
-
- Device Description
4
510(k) Submission number: K210679
The medical face masks are 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 spun-bond 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.
4. Intended Use
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
5. Test Summary
Medical face mask has been evaluated the safety and performance by lab bench testing according to the following standards:
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards. ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
6. Summary of Comparison and Technological Characteristics
Table 1 - General Comparison
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| Elements of Comparison | Subject Device(K210679) | Predicate Device(K200847) | Comments | |
|---|---|---|---|---|
| Product Name | Medical face mask | Surgical face mask | -- | |
| General Comparison | ||||
| Intended Use | When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. 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. | Same | |
| Model | 3 Ply, Ear Loops, Flat-Pleated Style | 3 Ply, Ear Loops, Flat-Pleated Style | Same | |
| Material | Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | Single Galvanize Wire, Coated By PE | Single Galvanize Wire, Coated By PE | Same | |
| Ear loops | Spandex | not made with natural rubber latex | Same | |
| Color | Blue | White | Different | |
| Note 1 | ||||
| Dimension (Width) | 9.5cm ± 0.5cm | 9.0cm ± 0.5cm | Similar | |
| Note 2 | ||||
| Dimension (Length) | 17.5cm ± 0.5cm | 17.5cm ± 0.5cm | Same | |
| Use | Single Use | Single Use | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Fluid Resistance Performance | ||||
| ASTM F 1862 | Lot 1: 32 Out of 32 pass at 120 mmHg | |||
| Lot 2: 32 Out of 32 pass at 120 mmHg | ||||
| Lot 3: 32 Out of 32 pass at 120 mmHg | 30 Out of 32 pass at 120 mmHg | Same | ||
| Elements of | ||||
| Comparison | Subject Device(K210679) | Predicate Device(K200847) | Comments | |
| Particulate Filtration | ||||
| Efficiency | ||||
| ASTM F 2299 | Lot 1:98.9% | |||
| Lot 2:98.9% | ||||
| Lot 3: 98.7% | 99.9% | Same | ||
| Bacterial Filtration | ||||
| Efficiency | ||||
| ASTM F2101 | Lot 1: 99.9% | |||
| Lot 2: 99.9% | ||||
| Lot 3: 99.9% | > 99.9% | Same | ||
| Differential Pressure | ||||
| (Delta P) | ||||
| EN 14683:2019+AC: | ||||
| 2019 | Lot 1: 3.0 mmH2 0/cm² | |||
| Lot 2: 3.1 mmH2 0/cm² | ||||
| Lot 3: 3.3 mmH2 0/cm² | 3.0 mmH2 0/cm² | Same | ||
| Flammability | ||||
| 16CFR 1610 | Lot 1: Class 1 | |||
| Lot 2: Class 1 | ||||
| Lot 3: Class 1 | Class 1 | Same | ||
| Cytotoxicity | Comply with ISO 10993-5 | |||
| Non cytotoxic | Comply with ISO 10993-5 | |||
| Non cytotoxic | Same | |||
| Irritation | Comply with ISO 10993-10 | |||
| Non irritating | Comply with ISO 10993- 10 | |||
| Non irritating | Same | |||
| Sensitization | Comply with ISO 10993-10 | |||
| Non sensitizing | Comply with ISO 10993- 10 | |||
| Non sensitizing | Same |
510(k) Submission number: K210679
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510(k) Submission number: K210679
Table 2 - Performance Testing
| Test Methodology | Purpose | Proposed
Device | Acceptance
Criteria | Result |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--------|
| Fluid Resistance
Performance
(ASTM F1862) | The test method is used to
evaluate the resistance of
medical face masks to
penetration by the impact of a
small volume(~2 mL) of
high-velocity stream of
synthetic blood. The pass/fail
determinations are based on
visual detection of synthetic
blood penetration. | Lot 1: 32 Out of
32 pass at 120
mmHg
Lot 2: 32 Out of
32 pass at 120
mmHg
Lot 3: 32 Out of
32 pass at 120
mmHg | 29 Out of 32
pass at 120
mmHg | Pass |
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| Sponsor: | Wuxi Yushou Medical Appliances Co., Ltd. | ||||
|---|---|---|---|---|---|
| Subject Device: | Medical face mask, model: Flat type | ||||
| File No.: | 510(k) submission report, Chapter 6 | ||||
| 510(k) Submission number: | K210679-S002 | ||||
| Particulate | |||||
| Filtration | |||||
| Efficiency | |||||
| (ASTM F2299) | The purpose of this test | ||||
| method is to measure the | |||||
| initial partical filtration | |||||
| efficiency of materials using | |||||
| monodispersed aerosols | |||||
| containing suspended latex | |||||
| spheres particulates of 0.1µm | |||||
| diameter. | Lot 1: 98.9% | ||||
| Lot 2: 98.9 % | |||||
| Lot 3: 98.7 % | ≥ 98% | Pass | |||
| Bacterial Filtration | |||||
| Efficiency | |||||
| (ASTM F2101) | The purpose of this test | ||||
| method is to determine the | |||||
| bacterial filtration efficiency of | |||||
| the mask as specified in | |||||
| ASTM F2101. | Lot 1: 99.9% | ||||
| Lot 2: 99.9% | |||||
| Lot 3: 99.9% | ≥ 98% | Pass | |||
| Flammability | |||||
| (16 CFR 1610) | The purpose of this test | ||||
| method is to determine the | |||||
| flammability charateristics of | |||||
| the mask as specified in 16 | |||||
| CFR Part 1610. Materials in | |||||
| the construction of medical | |||||
| face masks shall meet the | |||||
| requirements for Class 1, | |||||
| normal flammability specified | |||||
| in 16 CFR Part 1610. | Lot 1: Class 1 | ||||
| Lot 2: Class 1 | |||||
| Lot 3: Class 1 | Class 1 | Pass | |||
| Differential | |||||
| Pressure | |||||
| (EN 14683:2019) | The purpose of this test s to | ||||
| measure the differential | |||||
| pressure between the inside | |||||
| and outside of the mask. | Lot 1: 3.0 mmH2 | ||||
| 0/cm² | |||||
| Lot 2: 3.1 mmH2 | |||||
| 0/cm² | |||||
| Lot 3: 3.3 mmH2 | |||||
| 0/cm² |