(133 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
Explanation: The device is a face mask intended for infection control by preventing the transfer of microorganisms and particulate matter, not for treating a disease or condition.
No.
Explanation: The device is a face mask intended for protection against the transfer of microorganisms, body fluids, and particulate matter, and does not provide any diagnostic capabilities.
No
The device description clearly outlines a physical, multi-layered face mask made of polypropylene materials with earloops/tie strings and a nosepiece. The performance studies are bench tests on the physical properties of the mask (fluid resistance, filtration, pressure, flammability, biocompatibility). There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment.
- Device Intended Use: The intended use of the Nordiwell Medical Face Mask is to protect the wearer and others from the transfer of microorganisms, body fluids, and particulate matter. It's a physical barrier device.
- Device Description: The description details the physical construction of the mask and its materials.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide any diagnostic information. The performance studies focus on the physical barrier properties and safety of the mask.
Therefore, based on the provided information, the Nordiwell Medical Face Mask is a medical device used for personal protection and infection control, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nordiwell Medical Face Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matters. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Nordiwell Medical Face Mask has a flat-folded design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has earloops or tie strings to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. This is a single use, disposable device, provided 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
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. The test results demonstrated that the proposed device complies with the following standards:
(1) Performance test:
Bench test was conducted on 3 nonconsecutive lots of Medical Face Mask for proposed device to determine if the subject device met the specifications in the standard.
(2) Biocompatibility evaluation and test:
Biocompatibility evaluation conducted in accordance with FDA's 2020 guidance and ISO10993-1:2018 supports that the subject devices are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance: 31 of 32 pass at 120 mmHg (Acceptance Criteria: >=29 of 32 pass at 120 mmHg), Result: Pass
Particulate Filtration Efficiency: 99.9%, 32 of 32 pass (Acceptance Criteria: >= 98%), Result: Pass
Bacterial Filtration Efficiency: 99.9%, 32 of 32 pass (Acceptance Criteria: >= 98%), Result: Pass
Differential Pressure (Delta P): 4.6 mmH20/cm^2, 32 of 32 pass (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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June 29, 2021
Changzhou Combat Protective Equipment Co., Ltd. Xiaoqing Xue Quality Manager QingSiTang Village, Henglin Town, Wujin District Changzhou, Jiangsu 213101 China
Re: K210445
Trade/Device Name: Nordiwell Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 31, 2021 Received: March 31, 2021
Dear Xiaoqing Xue:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 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,
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210445
Device Name Nordiwell Medical Face Mask
Indications for Use (Describe)
The Nordiwell Medical Face Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matters. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) 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 K210445
1. Contact Information
1.1. Applicant
Applicant Name: Changzhou Combat Protective Equipment Co., Ltd. Address: Qingsitang, Henglin, Changzhou, Jiangsu, 213101 China Contact Person: Xiaoqing Xue Title: Quality Manager Telephone: +86-519-85190068; +86-15161196032 E-mail: xqxue2003@126.com
1.2. Consultant
Company: Sinow Medical AS Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway Contact Person: Huifang Zhao Telephone: +86 13961151430 Email: zhao@bergemed.com Date of the 510(k) Summary Prepared: June 25, 2021
2. Device information
Trade Name: Nordiwell Medical Face Mask Common Name: Surgical Face Mask Regulatory information: Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
3. Legally Marketed Primary Predicate Device
Product name: 3MTM High Performance Surgical Mask 510(k) Number: K180874 Product Code: FXX Manufacture: 3M Health Care
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4. Indication for use
The Nordiwell Medical Face Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate matters. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.
5. Device Description
The Nordiwell Medical Face Mask has a flat-folded design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has earloops or tie strings to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. This is a single use, disposable device, provided non-sterile.
| Device | Subject Device
K210445 Nordiwell Medical
Face Mask | Predicate Device
K180874 3M™ High
Performance Surgical Mask
1838R | Comparison |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intend
use/Indications
for Use | The Nordiwell Medical Face
Mask is intended to be worn
to protect both patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
matters. These face masks are
intended for use in infection
control practices to reduce
potential exposure to blood
and body fluids. This is a
single use, disposable
device(s) and provided non-
sterile. | 3M™ High Performance
Surgical Mask is intended to be
worn to protect both patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
material. These face mask(s) are
intended for use in infection
control practices to reduce
potential exposure to blood and
body fluids. This is a single use,
disposable device(s) and
provided non-sterile. | same |
6. Technological Characteristic Comparison
5
| Material | |||
|---|---|---|---|
| Outer Cover | |||
| Web | Polypropylene Spunbond | Polypropylene Spunbond, | |
| (w Print) – Upper Top Half | |||
| Polypropylene Spunbond, | |||
| White - Lower Bottom Half | same | ||
| Middle | |||
| Web/Filter | Polypropylene Melt Blown | Polypropylene Melt Blown | same |
| Inner Cover | |||
| Web | Polypropylene Spunbond | Polypropylene Spunbond | same |
| Earloops | |||
| or | |||
| tie strings | Spandex and Nylon | Polypropylene Spunbond or | |
| Polyethylene Terephthalate | Different¹ | ||
| Nose Piece | Polyethylene coated steel | ||
| wire | Polyethylene coated steel | ||
| wire | same | ||
| Design Features | |||
| Colors | White | Blue - Outer Cover Web (Upper) | |
| White - Outer Cover Web (Lower) | silimar | ||
| Mask Design | |||
| Style | Flat folded | Duckbill | Different² |
| Single Use | Yes | Yes | same |
| Sterility | |||
| Sterile | Non-Sterile | Non-Sterile | same |
| Dimension | |||
| Length | 160 mm ± 5 mm | 187 mm ± 4 mm | Different² |
| Width | 106 mm ± 5mm | 107 mm ± 6 mm | similar |
6
| Technological Characteristics: | |||
|---|---|---|---|
| Product Performance Specifications Per ASTM F2100 - Meets ASTM Level 2 | |||
| Fluid | |||
| Resistance | 31 of 32 pass at | ||
| 120 mmHg | Meet ASTM F2100 level 2 | ||
| and ASTM F1862 | |||
| requirement | same | ||
| Particulate | |||
| Filtration | |||
| Efficiency | 99.9%, | ||
| 32 of 32 pass | Meet ASTM F2100 level 2 | ||
| and ASTM F2299 | |||
| requirement | same | ||
| Bacterial | |||
| Filtration | |||
| Efficiency | 99.9%, | ||
| 32 of 32 pass | Meet ASTM F2100 level 2 | ||
| and ASTM F2101 | |||
| requirement | same | ||
| Differential | |||
| pressure | 4.6 mmH20/cm² | ||
| 32 of 32 pass | Meet ASTM F2100 level 2 | ||
| and MIL-M36954C | |||
| requirement | same | ||
| Flammability | Class 1, | ||
| 32 of 32 pass | Meet ASTM F2100 level 2 | ||
| and 16 CFR 1610 requirement | same | ||
| Shelf life | 2 years | Unknown | |
| Biocompatibility | |||
| Results | Biocompatible, | ||
| Non-Cytotoxic, | |||
| Non-Irritating, | |||
| Non-Sensitizing | Biocompatible, | ||
| Non-Cytotoxic, | |||
| Non- Irritating, | |||
| Non-Sensitizing | same |
Different': The patient contacting material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect.
Different2:The design style and dimension for proposed device is different from predicate device, but the differences of design and size don't affect the indication for use.
7. Non-Clinical Test
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
7
(1) Performance test:
Bench test was conducted on 3 nonconsecutive lots of Medical Face Mask for proposed device to determine if the subject device met the specifications in the standard. The bench tests include the following tests:
| Item | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance Performance | |||
| ASTM F1862-17 | 31 of 32 pass at | ||
| 120 mmHg | ≥29 of 32 pass at 120 mmHg | Pass | |
| Particulate Filtration | |||
| Efficiency ASTM F2299-17 | 99.9%, | ||
| 32 of 32 pass | ≥ 98% | Pass | |
| Bacterial Filtration Efficiency | |||
| ASTM F2101-19 | 99.9%, | ||
| 32 of 32 pass | ≥ 98% | Pass | |
| Differential Pressure | |||
| (Delta P) EN 14683:2019, | |||
| Annex C and ASTM | |||
| F2100-19. | 4.6 mmH20/cm² | ||
| 32 of 32 pass |