(113 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 technology.
No.
A therapeutic device is used to treat a disease or condition. This device is a mask intended to protect against microorganisms and fluids, which is a preventive measure, not a treatment.
No
Explanation: The device described is a procedure mask/surgical mask, which is intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its function is protective and not for diagnosing any medical condition.
No
The device description clearly outlines a physical, multi-layered mask made of nonwoven materials with ear loops/ties and a nose clip. There is no mention of software components or 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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of a face mask. There are no components or mechanisms described that would be used to perform a diagnostic test on a sample from the human body.
- Performance Studies and Key Metrics: The performance studies and key metrics listed (Resistance to Penetration, Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility tests) are all related to the physical and protective properties of the mask, not to the detection or measurement of substances in a biological sample.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic devices.
In summary, the device is a physical barrier intended for infection control, not a device used to perform tests on samples taken from the human body to diagnose a condition.
N/A
Intended Use / Indications for Use
The Procedure mask/Surgical 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, provided non-sterile.
Product codes
FXX
Device Description
The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.
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 (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 as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F1862/F1862M: 2017 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/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
- 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
- ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
Key results:
- Resistance to Penetration by Synthetic blood: Level 1: Pass at 80mmHg; Level 2: Pass at 120mmHg
- Particulate Filtration Efficiency: Blue mask: Pass at 96.05% (Level 1), Pass at 98.78% (Level 2); Black mask: Pass at 96.03% (Level 1), Pass at 98.75% (Level 2)
- Bacterial Filtration Efficiency: Blue mask: Pass at 98.25% (Level 1), Pass at 98.72% (Level 2); Black mask: Pass at 98.25% (Level 1), Pass at 98.73% (Level 2)
- Differential Pressure: Blue mask: Pass at 3.5 mmH2O/cm² (Level 1 and 2); Black mask: Pass at 3.5 mmH2O/cm² (Level 1), Pass at 3.6 mmH2O/cm2 (Level 2)
- Flammability: Class 1
- Cytotoxicity: The viability was ≥70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic.
- Sensitization: Under the conditions of the study, the proposed device was non-sensitizing.
- Irritation: Under the conditions of the study, the proposed device was non-irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to Penetration by Synthetic blood: Level 1: No penetration at 80 mmHg; Level 2: No penetration at 120 mmHg
Particulate Filtration Efficiency: Level 1: ≥95%; Level 2: ≥98%
Bacterial Filtration Efficiency: Level 1: ≥95%; Level 2: ≥98%
Differential Pressure: Level 1:
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
May 17, 2022
Winner Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K220194
Trade/Device Name: Procedure mask/Surgical mask/Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 9, 2022 Received: April 20, 2022
Dear Ms. Hong:
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 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 Brent 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Procedure mask/Surgical mask/Face mask
Indications for Use (Describe)
The Procedure mask/Surgical 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, 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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section
807.92. The assigned 510(k) Number: K220194
-
- Date of Preparation: 01/18/2022
-
- Sponsor Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No.660 Bulong Road, Longhua District, Shenzhen Guangdong, China 518109
Establishment Registration Number: 9616433
Contact Person: Mingni Liu Position: Regulatory Affairs Tel: +86-755-28138888-8822 Email: 2346@winnemedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Procedure mask/Surgical mask/Face mask Common Name: Surgical Face Mask
Regulatory Information Classification Name: Mask, Surgical; Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040; Review Panel: General Hospital;
Indications for use:
The Procedure mask/Surgical mask/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, provided non-sterile.
Device Description:
The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile. All specifications of the proposed device are provided in table 1.
| Product name | ASTM F2100-19
level | Ear strap type | Size (cm) | Color | Layers | Sterilization |
|-------------------------------------------------|------------------------|----------------|-----------|-------|--------|---------------|
| Procedure
mask/Surgical
mask/Face
mask | Level 1 | Ear loop | 17.5x9.5 | Blue | 3 | Non-sterile |
| | | | 17.5x9.5 | Black | | |
| | | Ear loop | 14.5x9 | Blue | | |
| | | | 14.5x9 | Black | | |
| | | Tie-on | 17.5x9.5 | Blue | | |
| Table 1 Procedure mask/Surgical mask Description | ||
|---|---|---|
5
| Level 2 | Ear loop | 17.5x9.5 | Blue | ||
|---|---|---|---|---|---|
| Black | |||||
| 14.5x9 | Blue | ||||
| Black | |||||
| Tie-on | 17.5x9.5 | Blue |
న్. Identification of Predicate Device
510(k) Number: K211462 Product Name: Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask (Select Level 1 and Level 2 masks as predicate device)
Summary of Non-Clinical Test 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ASTM F1862/F1862M: 2017 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/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
-
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;
-
ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
-
EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance to | |||
| Penetration by | |||
| Synthetic blood | The test was performed in accordance with ASTM | ||
| F1862/F1862M: 2017 | |||
| Standard Test Method for | |||
| Resistance of Medical Face | Level 1: No penetration | ||
| at 80 mmHg | Level 1: Pass at | ||
| 80mmHg | |||
| Level 2: No penetration | |||
| at 120 mmHg | Level 2: Pass at | ||
| 120mmHg | |||
| Masks to Penetration by | |||
| Synthetic Blood (Horizontal | |||
| Projection of Fixed Volume at | |||
| a Known Velocity) to evaluate | |||
| the effectiveness of the test | |||
| article from possible exposure | |||
| to blood and other body fluids. | |||
| The test was performed in | |||
| accordance with ASTM | |||
| F2299/F2299M-03 (2017) | |||
| Standard Test Method for | |||
| Determining the Initial | |||
| Efficiency of Material Used in | |||
| medical Face Masks to | |||
| Penetration by Particulates | |||
| using Latex Spheres to | |||
| determine the particle | |||
| filtration efficiency (PFE) of | |||
| the test article. | Level 1: ≥95% | Blue mask: | |
| Pass at 96.05% | |||
| Black mask: | |||
| Pass at 96.03% | |||
| Particulate | |||
| Filtration Efficiency | Level 2: ≥98% | Blue mask: | |
| Pass at 98.78% | |||
| Black mask: | |||
| Pass at 98.75% | |||
| Bacterial Filtration | |||
| Efficiency | The test was performed in | ||
| accordance with 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 to determine the | |||
| bacterial filtration efficiency | |||
| (BFE) of the test article. | Level 1: ≥95% | Blue mask: | |
| Pass at 98.25% | |||
| Black mask: | |||
| Pass at 98.25% | |||
| Level 2: ≥98% | Blue mask: | ||
| Pass at 98.72% | |||
| Black mask: | |||
| Pass at 98.73% | |||
| Differential | |||
| Pressure | The test was performed in | ||
| accordance with EN | |||
| 14683:2019+AC: 2019 Annex | |||
| C Medical face masks - | |||
| Requirements and test | |||
| methods to determine the | |||
| differential pressure of the test | |||
| article. | Level 1: |