(30 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a surgical mask intended to protect against transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, three-ply surgical mask made of nonwoven materials with ear loops or ties and a nosepiece. The performance studies are related to the physical properties and filtration capabilities of the mask, 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 against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function.
- Device Description: The description details the physical construction and materials of the mask.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are not diagnostic tests.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This surgical mask is used in vivo (on the body) as a physical barrier.
N/A
Intended Use / Indications for Use
The MASC Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This 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 provided non-sterile.
Product codes
FXX
Device Description
The MASC Surgical Mask is a three-ply, nonwoven, flat pleated mask. The MASC surgical mask consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The three layers of the mask body are collated with ultrasonically welded edges and comes in two models, an ear- loop model (NFR03U-01A) and a tie-on model (NFR03U-01B). The polyester spandex blend ear loops or polypropylene tie-on band are ultrasonically bonded to the sides of the non-filtration area of the mask to secure the mask over the user's mouth, nose and chin. A malleable polyethylene coated wire nosepiece is placed within the top binding for comfort and individualized fit over the nose. The MASC Surgical Mask is a single use, disposable, nonsterile device which conforms to ASTM F2100-19 Level 3. This device does not contain any natural rubber latex or fiber glass materials.
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
Not Found
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
Performance tests were performed to verify that the device meets the acceptance criteria.
Test Methodologies:
- 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
- ISO 22609: Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- EN 14683: Standard Test Method for Differential Pressure
- 16 CFR Part 1610: Standard for the Flammability of Clothing
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Performance Test Results:
- Fluid Resistance (ASTM F1862): Passed (160mmHg) for three non-sequential lots of 32 (total of 96, AQL 4.0).
- Lot 09142020-03U: 32/32 passed
- Lot 10052020-03U: 32/32 passed
- Lot 10072020-03U: 32/32 passed
- Bacterial Filtration Efficiency (ASTM F2101): Passed (>= 98%) for three non-sequential lots of 32 (total of 96, AQL 4.0) at 99.9%.
- Lot 09142020-03U: 32/32 passed at 99.9%
- Lot 10052020-03U: 32/32 passed at 99.9%
- Lot 10072020-03U: 32/32 passed at 99.9%
- Particulate Filtration Efficiency (ASTM F2299): Passed (>= 98%) for three non-sequential lots of 32 (total of 96, AQL 4.0).
- Lot 09142020-03U: 32/32 passed at 99.6 %
- Lot 10052020-03U: 32/32 passed at 99.9%
- Lot 10072020-03U: 32/32 passed at 99.9 %
- Differential Pressure (Delta P) (EN 14683): Passed (= 3.5 seconds) for three non-sequential lots of 32 (total of 96 ear-loop NFR03U-01A and 96 tie-on NFR03U-01B).
- Ear-loop: Lot 09142020-03U, Lot10052020-03U, Lot 10072020-03U all passed.
- Tie-on: Lot 09142020-03B, Lot10052020-03B, Lot 10072020-03B all passed.
- Cytotoxicity (ISO 10993-5): Passed (Reactivity grade should not be greater than grade 2). Non-cytotoxic.
- Irritation (ISO 10993-10): Passed (The difference between the test article and the control mean score is 1.0 or less). Non-irritating.
- Sensitization (ISO 10993-10): Passed (Grading score is 0). Non-sensitizing.
Summary of Clinical Testing: Not applicable; no clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance: 160mmHg
- Bacterial Filtration Efficiency: >= 98%
- Particulate Filtration Efficiency: >= 98%
- Differential Pressure (Delta P): = 3.5 seconds)
- Cytotoxicity: Reactivity grade should not be greater than grade 2
- Irritation: The difference between the test article and the control mean score is 1.0 or less
- Sensitization: Grading score is 0
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 25, 2021
Mid-America Safety Corp. % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K211984
Trade/Device Name: MASC Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: June 23, 2021 Received: June 25, 2021
Dear Prithul Bom:
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 (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, PhD 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
2
Indications for Use
510(k) Number (if known)
Device Name MASC Surgical Mask
Indications for Use (Describe)
The MASC Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This 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 provided non-sterile.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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800 GREENLEAF AVE, ELK GROVE VILLAGE IL 60007 www.midamericasafety.com, info@midamericasafety.com
K211984
510(k) Summary
| Sponsor Information: | Mid-America Safety Corp.
800 Greenleaf Ave.
Elk Grove Village, 60007 |
|----------------------|----------------------------------------------------------------------------|
| Contact Person: | Phil Fan, CEO
847-979-8606 |
847-979-8606 Phil@midamericasafety.com
Summary Preparation Date: 5/7/2021 Type of 510(k) Submission:Traditional 510 (k)
Device Name/Classification:
| Classification Name: | Surgical Apparel |
|---|---|
| Common Name: | Surgical Mask |
| Proprietary Name: | MASC Surgical Mask |
| Model | NFR03U-01A, NFR03U-01B |
| Classification Panel: | General and Plastic Surgery |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Device Classification: | Class II, 21 CFR 878.4040 |
Leqally Marketed Predicate Device:
| Classification Name: | Surgical Apparel |
|---|---|
| Common Name: | Surgical Face Mask |
| Model: | YX011, YX121 |
| Classification Panel: | General and Plastic Surgery |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Device Classification: | Class II, 21 CFR 878.4040 |
| 510 (k) number: | K202161 |
| Manufacturer: | Hunan EEXI Technology & Service Co., Ltd. |
Image /page/3/Picture/11 description: The image shows the word "MASC" in white letters against a red background. The letters are large and bold, filling most of the frame. The font appears to be sans-serif, and the overall design is simple and eye-catching. The red background provides a strong contrast to the white letters, making the word stand out.
4
800 GREENLEAF AVE, ELK GROVE VILLAGE IL 6 www.midamericasafety.com, info@midamericasafety.
Image /page/4/Picture/2 description: The image shows the word "MASC" in white letters on a red background. The letters are large and bold, and they take up most of the space in the image. The background is a solid red color, and it provides a strong contrast to the white letters. The image is simple and easy to read.
Indications for Use:
The MASC Surgical Mask is intended to be worn to protect bot the patient and the healthcare personnel from transfer of microorqanisms, body fluids and particulate material. This 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 provided non-sterile.
Device Description:
The MASC Surgical Mask is a three-ply, nonwoven, flat pleated mask. The MASC surgical mask consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The three layers of the mask body are collated with ultrasonically welded edges and comes in two models, an ear- loop model (NFR03U-01A) and a tie-on model (NFR03U-01B). The polyester spandex blend ear loops or polypropylene tie-on band are ultrasonically bonded to the sides of the non-filtration area of the mask to secure the mask over the user's mouth, nose and chin. A malleable polyethylene coated wire nosepiece is placed within the top binding for comfort and individualized fit over the nose. The MASC Surgical Mask is a single use, disposable, nonsterile device which conforms to ASTM F2100-19 Level 3. This device does not contain any natural rubber latex or fiber glass materials.
Technological Characteristic Comparison:
| Item(s) | Subject Device
MASC Surgical Mask | Predicate Device
Hunan EEXI Technology &
Service Co.,Ltd.
Surgical Face Mask | Comparison |
|-------------------|--------------------------------------|---------------------------------------------------------------------------------------|------------|
| 510(k) # | K211984 | K202161 | |
| Commercial Name | MASC Surgical Mask | Surgical Face Mask | |
| Common Name | Surgical mask | Surgical Face mask | Same |
| Regulation Name | Surgical apparel | Surgical apparel | Same |
| Regulation Class | Class II | Class II | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Product Code | FXX | FXX | Same |
Table 1 Comparison of Subject and Predicate Devices
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800 GREENLEAF AVE, ELK GROVE VILLAGE IL 60007 www.midamericasafety.com, info@midamericasafety.com
Image /page/5/Picture/2 description: This image shows a comparison of two surgical masks. The MASC surgical mask is a three-ply, nonwoven, flat pleated mask that consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
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Image /page/6/Picture/1 description: The image shows the word "MASC" in white letters against a red background. The letters are bold and sans-serif. The background is a solid red color, and the letters are evenly spaced.
800 GREENLEAF AVE, ELK GROVE VILLAGE IL 60007 www.midamericasafety.com, info@midamericasafety.com
| Intended Use / | The MASC Surgical Mask is | The Surgical Face Masks are | Same | |
|---|---|---|---|---|
| Indications for Use | intended to be worn to protect both | |||
| the patient and healthcare | ||||
| personnel from transfer of | ||||
| microorganisms, body fluids and | ||||
| particulate material. This 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 provided non- | ||||
| sterile. | intended to be worn to protect both | |||
| the patient and healthcare | ||||
| personnel from transfer of | ||||
| microorganisms, body fluids and | ||||
| particulate material. These 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 provided non- | ||||
| sterile. | ||||
| Design feature | Ear-loop, Tie-on | Ear-loop, Tie-on | Same | |
| Type of use | Over-The-Counter Use (21 CFR | |||
| 801 Subpart C) | Over-The-Counter Use (21 CFR | |||
| 801 Subpart C) | Same | |||
| Material Composition | ||||
| 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 | Polyethylene and wire | Polyethylene and wire | Same | |
| Ear loop | Elastic Polyester/spandex blend | Elastic fiber | Similar | |
| Tie-on | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Specifications | ||||
| Mask Style | Flat Pleated | Flat Pleated | Same | |
| Length | $17.5cm \pm 1.0 cm$ | $17.5cm \pm 1.0cm$ | Same | |
| Width | $9.5cm \pm 1.0cm$ | $9.5cm \pm 1.0 cm$ | Same | |
| Sterile | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use | Single Use | Same | |
| Color | Blue | Blue | Same | |
| Ear-loop | $16.5cm \pm 2.5cm$ | |||
| Tie-On | $10.0mm\pm 3mm x 87.0 cm\pm5.0cm$ | |||
| Performance | ||||
| Performance Testing | Level 3-ASTM F2100-19 | Level 3-ASTM F2100-19 | Same | |
| Fluid Resistance | Three non-sequential lots of 32 | |||
| (total of 96, AQL 4.0) passed at | ||||
| 160mmHg -- ASTM F1862 |
Lot 09142020-03U: 32/32 passed
Lot 10052020-03U: 32/32 passed
Lot 10072020-03U: 32/32 passed | Meet the ASTM F2100
Requirements for Level 3
Classification, ) passed at
160mmHg -- ASTM F1862 | Same | |
| Bacterial Filtration
Efficiency | Three non-sequential lots of 32
(total of 96, AQL 4.0) passed at ≥
98% - ASTM F2101
Lot 09142020-03U: 32/32 passed
at 99.9%
Lot 10052020-03U: 32/32 passed
at 99.9%
Lot 10072020-03U: 32/32 passed
at 99.9% | Meet the ASTM F2100
Requirements for Level 3
Classification, passed at ≥98% -
ASTM F2101 | Same | |
| Particulate Filtration
Efficiency | Three non-sequential lots of 32
(total of 96, AQL 4.0) passed at ≥
98% - ASTM F2299
Lot 09142020-03U: 32/32 passed
at 99.6 %
Lot 10052020-03U: 32/32 passed
at 99.9%
Lot 10072020-03U: 32/32 passed
at 99.9 % | Meet the ASTM F2100
Requirements for Level 3
Classification, passed at ≥98% -
ASTM F2299 | Same | |
| Differential Pressure
(Delta P) | Three non-sequential lots of 32
(total of 96, AQL 4.0) passed at