(188 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate materials, not to treat or cure a disease or condition.
No
The device is a surgical face mask, which is intended to protect against the transfer of microorganisms, body fluids, and particulate materials, not to diagnose a medical condition.
No
The device description clearly outlines physical components (multi-layer mask, earloops/ties, nose piece) and performance studies relate to physical properties (filtration, fluid resistance, flammability), indicating it is a hardware device.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Surgical Face Mask Function: The provided description clearly states the intended use of the surgical face mask is to "protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials." This is a barrier function, not a diagnostic function.
- Lack of Diagnostic Testing: The device description and performance studies focus on the physical properties and barrier effectiveness of the mask (filtration, fluid resistance, breathability, biocompatibility). There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, based on the provided information, the Surgical Face Mask is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
Product codes
FXX
Device Description
Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.
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
operating room personnel and other general healthcare workers
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)
The following performance tests of Surgical Face Mask were conducted:
- Fluid Resistance Performance ASTM F1862-17: Purpose - To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids. Acceptance criteria - No penetration pass at 160mmHg. Results - Pass, no penetration pass at 160mmHg.
- Particulate Filtration Efficiency ASTM F2299-17: Purpose - To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. Acceptance criteria - greater than or equal to 98%. Results - Pass, CM2006 and CM2008: Average 99.88%, A88: Average 99.56%
- Bacterial Filtration Efficiency ASTM F2101-19: Purpose - To evaluate the bacterial filtration efficiency (BFE) of mask. Acceptance criteria - greater than or equal to 98%. Results - Pass, CM2006 and CM2008: Average 99.88%, A88: Average 99.9%
- Differential Pressure (Delta P) EN 14683:2019, Annex C and ASTM F2100-19: Purpose - To measure the differential pressure of mask which is related to breathability. Acceptance criteria - less than 6.0 mmH2O/cm2. Results - Pass, CM2006 and CM2008: Average 3.69 mmH2O/cm2, A88: Average 3.55 mmH2O/cm2
- Flammability 16 CFR 1610: Purpose - To evaluate the flammability of mask. Acceptance criteria - Class 1. Results - Pass, Class 1
- In Vitro Cytotoxicity ISO 10993-5: Purpose - To evaluate the biological safety of the product which has direct contact with intact skin. Acceptance criteria - The test article should not have potential toxicity to L-929 in the MTT method. Results - Pass, the test article Surgical face mask has no potential toxicity to L-929 in the MTT method.
- Skin Sensitization ISO 10993-10: Purpose - To evaluate the biological safety of the product which has direct contact with intact skin. Acceptance criteria - The test article should not cause delayed dermal contact sensitization in the guinea pig. Results - Pass, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article Surgical face mask has no potential skin sensitization on guinea pigs in the extraction method.
- Skin Irritation ISO 10993-10: Purpose - To evaluate the biological safety of the product which has direct contact with intact skin. Acceptance criteria - The irritation response category in the rabbit should be negligible. Results - Pass, the response of the test article extract was categorized as negligible under the test condition. The test article Surgical Face Mask has no potential skin irritation on rabbit in the extraction method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance: No penetration pass at 160mmHg.
- Particulate Filtration Efficiency: CM2006 and CM2008: Average 99.88%, A88: Average 99.56%
- Bacterial Filtration Efficiency: CM2006 and CM2008: Average 99.88%, A88: Average 99.9%
- Differential Pressure: CM2006 and CM2008: Average 3.69 mmH2O/cm², A88: Average 3.55 mmH2O/cm²
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.
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 28, 2021
Shenzhen RealTone Medical Appliance Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K210878
Trade/Device Name: Surgical Face Mask (Model: CM2006, CM2008, A88) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 19, 2021 Received: March 24, 2021
Dear Tracy Che:
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 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
2
Indications for Use
510(k) Number (if known) K210878
Device Name
Surgical Face Mask (Model: CM2006, CM2008, A88)
Indications for Use (Describe)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
| 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
K210878 510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information
| 510 (k) owner's name: | Shenzhen RealTone Medical Appliance Co., Ltd. |
|---|---|
| Address: | Flat B, 5 Floor, Yaoxiang Industrial Building, No.92 Fukang Road, |
| Henggang Street, Longgang District, Shenzhen, China | |
| Contact person: | Wei Zhou |
| Phone number: | 86-755-28266631 |
| Fax number: | / |
| Email: | akoszhou@163.com |
| Date of summary prepared: | 2021-9-7 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name: | Surgical Face Mask (Model: CM2006, CM2008, A88) |
|---|---|
| Regulation Name: | Surgical apparel |
| Regulation number: | 21 CFR 878.4040 |
| Product code: | FXX |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate device
| Sponsor | Mexpo International Inc. |
|---|---|
| Device Name | Avianz® Surgical Face Mask |
| 510(k) Number | K200847 |
| Product Code | FXX |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Class | II |
(5) Description/ Design of device
Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2
4
options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.
(6) Indications for use
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
(7) Materials
| Component of Device
Requiring
Biocompatibility | Material of Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------|
| Surgical Face Mask
(Model:CM2006) | Spun-bond polypropylene;
melt-blown polypropylene;
Single Galvanize Wire,
Coated By Polyethylene;
Chinlon+Spandex Elastic
Fiber. | Surface-contacting
device: skin | 99.9% | Similar |
| Delta - P | CM2006 and CM2008:
Average 3.69 mmH2O/cm²
A88: Average 3.55 mmH2O/cm² | 3.0 mmH2O/cm² | Similar,
both masks
met
requirements of