(46 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Surgical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ties (polypropylene spunbond white). The mask contains a malleable nosepiece which is centrally positioned between the opposed side edges along the top edge of the mask. The nosepiece is a stable anchor in the vicinity of the nose and readily bent to conform to contours of a person's face. Thus the nosepiece can provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made with natural rubber latex and Shelf-life of the device is 2 years. The subject of this submission is a design change to the ear-loop in the Nordiwell Medical Face Mask(K202615). The ear-loop of the Nordiwell Medical Face Mask(K202615) is changed to tie in the subject device.
This document describes the acceptance criteria and supporting study for the Nordiwell Surgical Face Mask (K210181), which is a surgical face mask.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for surgical face masks.
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | 160 mmHg | 32 of 32 pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% at 0.1 micron | > 99.9% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | ≥ 98% |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | 5.6 mmH2O/cm² |
| Flammability | Class 1 | Class 1 |
| Biocompatibility: | ||
| - In Vitro Cytotoxicity | Non-cytotoxic | Non-Cytotoxic |
| - Skin Irritation | Non-irritating | Non-Irritating |
| - Skin Sensitization | Non-sensitizing | Non-Sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test, but it indicates "32 of 32 pass" for fluid resistance, implying a sample size of 32 for that particular test. The data provenance is implied to be from the manufacturer, Changzhou Combat Protective Equipment Co., Ltd., based in China, as per the contact information provided in the 510(k) summary. The studies are non-clinical (bench testing) and therefore not retrospective or prospective in the human study sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the studies are non-clinical bench tests comparing the device's physical properties against established industry standards (ASTM F2100). No human experts were used to establish ground truth in the context of clinical interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical bench tests for physical properties according to standardized methods. No human adjudication was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. The device is a surgical face mask, and performance is evaluated through bench testing against established standards, not through reader studies.
6. Standalone Performance Study
Yes, a standalone study was done. The document explicitly states: "Bench testing was conducted to demonstrate the performance of the subject device." The results of these bench tests are presented against the ASTM F2100 Level 3 criteria, indicating the algorithm's (device's) standalone performance for various physical and filtration properties.
7. Type of Ground Truth Used
The ground truth used for evaluation is established industry standards (ASTM F2100 Level 3) for surgical face mask performance and international standards for biocompatibility (ISO 10993 series). These are objective, quantifiable criteria.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an AI algorithm or a device requiring a training set in that context. The "training set" concept is irrelevant to a physical product's performance validation against standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
{0}------------------------------------------------
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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 9, 2021
Changzhou Combat Protective Equipment Co., Ltd. Tao Wang Development Manager QingSiTang Village, Henglin Town, Wujin District Changzhou, Jiangsu 213101 China
Re: K210181
Trade/Device Name: Nordiwell Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 22, 2021 Received: March 1, 2021
Dear Tao Wang:
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 Ryan Ortega, Ph.D. Acting 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}------------------------------------------------
Indications for Use
510(k) Number (if known) K210181
Device Name Nordiwell Surgical Face Mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K210181
510(k) Summary
Date Prepared: 02/20/2021
1. Contact Information
1.1. Applicant
Applicant Name: Changzhou Combat Protective Equipment Co., Ltd. Address: Qingsitang, Henglin, Changzhou, Jiangsu, 213101 China Contact Person: Tao Wang Title: Development Manager Telephone: +86-519-85190068 E-mail: zhao.huifang@hotmail.com 1.2. Consultant Company: Sinow Medical AS Address: Høyteknologisenteret, Thorm chlens gate 55, 5006 Bergen, Norway Contact Person: Huifang Zhao Telephone: +86 13961151430 Email: zhao@bergemed.com
2. Device information
Trade Name: Nordiwell Surgical 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
Nordiwell Medical Face Mask (K202615)
4. Indication for use
When properly worn, the surgical face masks are intended to protect both patient and
{4}------------------------------------------------
healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
5. Device Description
The Nordiwell Surgical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ties (polypropylene spunbond white). The mask contains a malleable nosepiece which is centrally positioned between the opposed side edges along the top edge of the mask. The nosepiece is a stable anchor in the vicinity of the nose and readily bent to conform to contours of a person's face. Thus the nosepiece can provide a firm fit over the nose and then to secure the mask over the users' mouth and face.
The mask is a single use, provided non-sterile.
This device is not made with natural rubber latex and Shelf-life of the device is 2 years.
The subject of this submission is a design change to the ear-loop in the Nordiwell Medical Face Mask(K202615). The ear-loop of the Nordiwell Medical Face Mask(K202615) is changed to tie in the subject device.
| Device | Subject Device (K210181)Nordiwell Surgical Face Mask,Model 952002 | Predicate Device (K202615)Nordiwell Medical Face Mask,Model 952001 | Comparison | ||||
|---|---|---|---|---|---|---|---|
| Indications for Use | When properly worn, the surgicalface masks are intended to protectboth patient and healthcare workersfrom transfer of microorganisms,body fluids and particulate matter.This device is non-sterile and forsingle use only. | When properly worn, the medicalface masks are intended to protectboth patient and healthcare workersfrom transfer of microorganisms,body fluids and particulate matter.This device is non-sterile and forsingle use only. | Same | ||||
| Material | |||||||
| Outer Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | ||||
| Filter(Middle layer) | Melt Blown Polypropylene Filter | Melt Blown Polypropylene Filter | Same | ||||
| Inner Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
6. Comparison of Technological Characteristics
{5}------------------------------------------------
| Nose Wire | Single Galvanize Wire, Coated by Polypropylene | Single Galvanize Wire, Coated by Polypropylene | Same |
|---|---|---|---|
| Attachment | Tie: Spunbond Polypropylene | Ear-Loop: Spandex and Nylon; Not made with natural rubber. | Different |
| Design Features | |||
| Colors | Blue | Blue | Same |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple Layers | 3 | 3 | Same |
| Single Use | Yes | Yes | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | |||
| Sterile | Non-Sterile | Non-Sterile | Same |
| Dimension | |||
| Length | 17.5cm ±0.5cm | 17.5cm ±0.5cm | Same |
| Width | 9.5cm ±0.5cm | 9.5cm ±0.5cm | Same |
| Biocompatibility | |||
| In Vitro Cytotoxicity TestISO 10993-5: 2009 | Non-Cytotoxic | Non-Cytotoxic | Same |
| Skin Irritation TestISO 10993-10:2010 | Non-Irritating | Non-Irritating | Same |
| Skin Sensitization TestISO 10993-10:2010 | Non-Sensitizing | Non-Sensitizing | Same |
| Performance | |||
| ASTM F2100 Level | Level 3 | Level 3 | Same |
| Fluid Resistance PerformanceASTM F1862 | 32 of 32 pass at 160 mmHg | 32 of 32 pass at 160 mmHg | Same |
| Particulate Filtration EfficiencyASTM F2299 | > 99.9% | 99.9% | Same |
| Bacterial Filtration EfficiencyASTM F2101 | ≥98% | > 99.9% | Same |
| Differential Pressure(Delta P) | 5.6 mmH20/cm2( EN 14683:2019, Annex Cand ASTM F2100-19) | 5.6 mmH20/cm2( EN 14683:2019, Annex C andASTM F2100-19) | Same |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Same |
{6}------------------------------------------------
7. Description of the change
The sole modification is the replacement of the ear-loop of the predicate device with a tie attachment. The essential function and performance of the face mask depend on the main body of the mask. The function of ear-loop and tie is to allow the main body of the mask to cover important parts of the face to achieve a protective effect. According to the Instruction for Use, both the ear-loop and tie can achieve the function of fixing the mask. So the modification does not affect the indication for use, essential function and performance of the device.
The labeling will require minor changes in the device name, description and donning/doffing procedures.
8. Performance data
8.1. Non-clinical Performance Testing:
(1) Bench testing was conducted to demonstrate the performance of the subject device. The bench testing includes the following tests: Fluid Resistance Performance (ASTM F1862-17) Particulate Filtration Efficiency (ASTM F2299-17) Bacterial Filtration Efficiency (ASTM F2101-19) Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) Flammability (16 CFR 1610)
(2) Biocompatibility evaluation and test Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and ISO10993-1:2018 supports that the subject devices are biocompatible. The biocompatibility test includes the following tests: In Vitro Cytotoxicity Test(ISO 10993-5: 2009) Skin Irritation Test(ISO 10993-10:2010) Skin Sensitization Test(ISO 10993-10:2010)
8.2. Clinical Performance Testing
No clinical study is included in this submission.
9. Conclusion
{7}------------------------------------------------
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210181, the Nordiwell Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202615.
§ 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.