(239 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 for infection control and protection, not for treating or rehabilitating a medical condition.
No.
A surgical mask is a protective barrier device, not a device used to identify the presence of a disease or condition. Its purpose is to prevent the transfer of microorganisms and fluids.
No
The device description clearly outlines physical components like spunbonded and melt blown polypropylene, ear loops, and a nose piece made of polypropylene and metal wire, indicating it is a physical medical device, not software-only.
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, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (fluid resistance, filtration efficiency, breathability, biocompatibility), which are relevant to its function as a barrier, not as a diagnostic tool.
In summary, the device is a surgical mask, which is a personal protective equipment (PPE) designed to prevent the spread of respiratory droplets and particles. It does not perform any diagnostic function.
N/A
Intended Use / Indications for Use
The 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(s), provided non-sterile.
Product codes
FXX
Device Description
The Surgical Mask is a single use, Flat Pleated mask with ear loops and nose piece. The Surgical Mask is consisting of three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The Surgical Mask uses different colors to distinguish the inner and outer layers, the inner layer is white and the outer layer is blue. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire. The Surgical Mask is sold non-sterile and is intended to be single use, disposable 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
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 subject device met all design specifications as the predicate device. The test results demonstrate that the subject device conforms to the recognized standards ASTM F2100-19, ISO 10993-5 and ISO 10993-10 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notification [510(k)] Submission issued on March 5, 2004.
Test results include:
Fluid Resistance Performance: 32 out of 32 passes at 120mmHg
Particulate Filtration Efficiency: 99.79%
Bacterial Filtration Efficiency: 99.70%
Differential Pressure (ΔΡ): 3.813 mm H2O/cm²
Flammability: Class 1
Cytotoxicity: Non-cytotoxic
Irritation: Non-irritating
Sensitization: Non-sensitizing
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance: 32 out of 32 passes at 120mmHg
Particulate Filtration Efficiency: 99.79%
Bacterial Filtration Efficiency: 99.70%
Differential Pressure (ΔΡ): 3.813 mm H2O/cm²
Flammability: Class 1
Cytotoxicity: Non-cytotoxic
Irritation: Non-irritating
Sensitization: Non-sensitizing
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 2, 2021
Huizhou Foryou Medical Devices Co., Ltd Guosheng Tan Development Engineer No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou, Guangdong 516005 China
Re: K201852
Trade/Device Name: Surgical Mask-Model Number: Ear Loop, Flat-Pleated Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 27, 2021 Received: February 1, 2021
Dear Guosheng Tan:
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,
For Ryan Ortega, PhD 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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: 0MB No. 0910-0120 Expiration Date: 0613012020 See PRA Statement below.
510(k) Number (if known) K201852
Device Name Surgical Mask
Indications for Use (Describe)
The 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(s), 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)
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 0MB number."
FORM FDA 3881 (7117)
Page 1 of 1
PSC Publishing Scrdccs (301)443-67-IO EF
3
510(k) Summary
This 510(k) Summary information is being submitted in accordance with the requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K201852
1. Submitter:
Huizhou Foryou Medical Devices Co., Ltd.
| Address: | No.1 Shangxia North Road, Dongjiang Hi-tech Industry
Park, Huizhou, Guangdong, China |
|-----------------|-----------------------------------------------------------------------------------------|
| Phone: | +86-0752-5302185 |
| Fax: | +86-0752-5302020 |
| Contact Person: | Guosheng Tan |
| Date Prepared: | March 2, 2021 |
- Subject Device:
| Trade Name: | Surgical Mask |
|---|---|
| Common Name: | Surgical Mask |
| Classification Name: | Mask, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR §878.4040 |
| Device Class: | Class II |
-
- Predicate Device:
K182515
- Predicate Device:
Surgical Face Mask
Wuhan Dymex Healthcare Co., Ltd
Page 1 of 4
4
4. Device Description:
The Surgical Mask is a single use, Flat Pleated mask with ear loops and nose piece. The Surgical Mask is consisting of three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The Surgical Mask uses different colors to distinguish the inner and outer layers, the inner layer is white and the outer layer is blue. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire. The Surgical Mask is sold non-sterile and is intended to be single use, disposable devices.
5. Indications for Use:
The 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(s), provided non-sterile.
6. Technological Characteristics Comparison
Table 5.1 Comparison of technological characteristics between subject device
| Item | Subject Device
(K201852) | Predicate Device
(K182515) | Comparison |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Surgical Mask is
intended to be worn to
protect both the patient
and healthcare personnel
from transfer of
microorganisms, body | The Surgical Face Masks
are intended to be worn to
protect both the patient
and healthcare personnel
from transfer of
microorganisms, body | Same |
and predicate device
5
| | | 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(s),
provided non-sterile. | 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(s),
provided non-sterile. | | |
|--|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------|
| | Model | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same | |
| | Material | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | | Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| | | Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nosepiece | Malleable polypropylene
and metal wire | Malleable polyethylene
wire | Similar | |
| | Ear loops | Spandex | Spandex | Same | |
| | Color | Blue/White | Yellow | Different* | |
| | Dimension | Length | $17.5cm \pm 1cm$ | $17.5cm \pm 0.2cm$ | Same |
| | | Width | $9.5cm \pm 1cm$ | $9.5cm \pm 0.2cm$ | Same |
| | Sterility | | Non-Sterile | Non-Sterile | Same |
| | Use | | Single Use, Disposable | Single Use, Disposable | Same |
| | ASTM F2100 Level | | Level 2 | Level 2 | Same |
*The difference in the color does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all color additives.
7. Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications as the predicate device. The test results demonstrate that the subject device conforms to the recognized standards ASTM F2100-19, ISO 10993-5 and ISO 10993-10 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notification [510(k)] Submission issued on March 5, 2004. Detailed test results are shown in the table 5.2.
6
| Performance
| Characteristics | Test Method | Acceptance Criteria | Test Result |
|---|---|---|---|
| Fluid Resistance | |||
| Performance | ASTM F1862/F1862M-17 | 29 out of 32 passes at | |
| 120mmHg | 32 out of 32 passes at | ||
| 120mmHg | |||
| Particulate | |||
| Filtration | |||
| Efficiency | ASTM F2299/F2299M-03 | ≥98% | 99.79% |
| Bacterial Filtration | |||
| Efficiency | ASTM F2101-19 | ≥98% | 99.70% |
| Differential | |||
| Pressure (ΔΡ) | MIL-M-36954C |