(169 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard face mask, with no mention of AI or ML.
No.
The device's intended use is to protect from transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
Explanation: The device is a medical face mask, a physical barrier intended to prevent the transfer of microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (layers of polypropylene, tie strings/ear loops, nose piece) and performance studies focus on material properties and physical filtration, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting individuals from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of a face mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and metrics focus on the physical and barrier properties of the mask (filtration efficiency, pressure, resistance to penetration, flammability, biocompatibility). These are not metrics related to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This face mask does not fit that description.
N/A
Intended Use / Indications for Use
The Medical Face Masks are 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. The Medical Face Masks are single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer (meltblown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with white plastic covering) to provide a firm 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 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 was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Medical Face Mask complies with the following standards:
- ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101 Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- MIL-M- 36954C Military Specification, Mask, Surgical, Disposable
- 16 CFR Part 1610 Standard for the Flammability of Clothing
- ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
- ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
Clinical Test Conclusion: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial Filtration Efficiency Performance: 99.9% (Acceptance Criteria: >=98)
- Differential Pressure (Delta-P): 2.11mmH2O/cm^2 (Acceptance Criteria: =98)
- Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass results: 32/32 passed at 120 mmHg (Acceptance Criteria: 120)
- Flammability Class: Class 1 (Acceptance Criteria: Class 1)
- Cytotoxicity: Non-cytotoxic (Acceptance Criteria: If viability is reduced to
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 2, 2021
Gemtier Medical (Shanghai) Inc % Julie Chen Technical Manager Shanghai Medical Business Consulting Co.,Ltd. No. 170 Huajiang Road, Jiading District Shanghai, 201803 China
Re: K202331
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 24, 2020 Received: January 6, 2021
Dear Julie Chen:
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.
1
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 (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 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.
For 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202331
Device Name Medical Face Mask
Indications for Use (Describe)
The Medical Face Masks are 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. The Medical Face Masks are single use, disposable device, 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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3
510(K) Summary-K202331
I. SUBMITTER:
Gemtier Medical (Shanghai) Inc. No.18 Jianding road, Fengjing town, Jinshan district, Shanghai, China, 201502
Contact Person: Li Zhi Qing Title: RA Director Phone: (+86) 189 1703 5908 Email: lizhiqing@jintayiqi.com
Submission Correspondent: Julie Chen Title: RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai, China, 200040 Email: julie.chen@medicalbc.net Tel: +86 139 1804 5781
Summary prepared: 01/18/2021
II. DEVICE
Name of Device: Medical Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX
III. PREDICATE DEVICE
Primary predicate device: Disposable Surgical Face Mask (K153496)
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IV. DEVICE DESCRIPTION
The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer (meltblown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with white plastic covering) to provide a firm fit over the nose.
| REF No. | Product Size | Model Description | ||
|---|---|---|---|---|
| Mask | Ear Loop | Tie-on | ||
| NS2R-D1 | 17.5×9.5cm | X | X | |
| NS2R-01 | 17cm×9.5cm | X | X | |
| NS2R-C1 | 14.5cm×9.5cm | X | X | |
| NS2R-I1 | 17.5×9.5cm | X | X | X |
| NS2R-E1 | 17cm×9.5cm | X | X | X |
| NS2R-H1 | 14.5cm×9cm | X | X | X |
V. Available Models
VI. INDICATIONS FOR USE
The Medical Face Masks are 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. The Medical Face Masks are single use, disposable device, provided non-sterile
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
The Medical Face Masks are compared with the predicate device (Disposable Surgical Face Mask (K153496)). The results are shown below in the Technological Characteristics Comparison Table:
| Subject Device Medical | Primary Predicate Device | Remark | |
|---|---|---|---|
| DEVICE | Face Mask (K202331) | Disposable Surgical Face | |
| Mask (K153496) | |||
| Intended Use | The Medical Face Masks are | ||
| 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. | |||
| The Medical Face Masks are single | |||
| use, disposable device, provided | |||
| non-sterile. | The Disposable Surgical Face | ||
| Masks are 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. | Same | ||
| Classification Product | |||
| Code | FXX | FXX | Same |
| Ear Loop Model and | |||
| Tie-on | |||
| Model | Ear Loops, Tie-On | Ear Loops, Tie-On | Same |
| Materials | |||
| Outer Facing Layer | Spun-bond Polypropylene | Spun-bond polypropylene | Similar |
| Middle Layer | Melt-blown polypropylene | Melt blown polypropylene | |
| filter | Similar | ||
| Inner Facing Layer | Spun-bond Polypropylene | Spun-bond polypropylene | Similar |
| Nose Piece | Malleable iron wire with | ||
| plastic covering | Malleable aluminum wire | Different 1 | |
| Tie Strings | Spun-bond Polypropylene | Spun-bond polypropylene | Similar |
6
| Ear Loops | Spandex elastic cord | Polyester | Similar |
|---|---|---|---|
| Design Features | |||
| Color | Blue | Blue | Same |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple Layers | 3 Layers | 3 Layers | Same |
| Single Use | Single use | Single use | Same |
| Sterility | |||
| Sterile | Non-sterile | Non-sterile | Same |
| Dimensions | |||
| Length × Width | 175×95mm (±5%) | ||
| 170×95mm (±5%) | |||
| 145×95mm (±5%) | 17.5×9.5cm (±1cm) | Similar | |
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 2 | |||
| Fluid Resistance ASTM | |||
| F1862 | 32/32 passed at 120 mmHg | 32/32 passed at 120 mmHg | Similar |
| Particulate Filtration | |||
| Efficiency | |||
| (PFE) ASTM F2299 | 99.35% | 98.46% | Similar |
| Bacterial Filtration | |||
| Efficiency | |||
| (BFE) ASTM F2101 | 99.9% | 98.7% | Similar |
| Differential Pressure | |||
| (Delta P) | |||
| MIL-M-36954C | 2.11mmH2O/cm² | 4.2mmH2O/cm² | Similar |
| Flammability | |||
| 16 CFR PART 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Similar |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Same |
| Irritation (ISO 10993-10) | Non-sensitizing | Non-sensitizing | Same |
| Sensitization (ISO | |||
| 10993-10) | Non-irritating | Non-irritating | Same |
Analysis 1
The material of nose piece of the subject device is different from the material of nose piece of the predicate device. To illustrate the difference does not raise any safety and effectiveness questions, we conducted non-clinical tests. The data drawn from the tests shows that the subject device is as safe as effective as predicate device.
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VIII. PERFORMANCE DATA
Non-Clinical Performance Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Medical Face Mask complies with the following standards:
- . ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to . Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of . Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101 Standard Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- MIL-M- 36954C Military Specification, Mask, Surgical, Disposable ●
- 16 CFR Part 1610 Standard for the Flammability of Clothing ●
- ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
- . ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
- ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization
Clinical Test Conclusion
No clinical study is included in this submission.
8
Table 1 Summary of Performance Test
| Performance
Characteristics | Methodology | Purpose | Acceptance
Criteria | Test Result |
|--------------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Bacterial Filtration
Efficiency
Performance(%) | ASTM F2101 | This performance
test aims to verify
Bacterial Filtration
Efficiency (BFE)
of the Medical face
mask reaches level
2 as required in
ASTM F 2100-
2019 | ≥98 | 99.9% |
| Differential Pressure (Delta-
P)
(mm H2O/cm²) | MIL-M-36954C | This performance
test aims to verify
the breathing
resistance of
Medical face mask
reaches level 2 as
required in ASTM
F 2100-2019 |