(49 days)
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 acts as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate material, which is a protective function, not a therapeutic one.
No
This device is a surgical face mask intended to protect against microorganisms and body fluids. It acts as a physical barrier, not as a tool for diagnosis.
No
The device description clearly states it is a physical mask made of various fabric layers and components, not software.
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 individuals from microorganisms, body fluids, and particulate material transfer. This is a physical barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of the mask, emphasizing its role as a physical barrier.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a person's health status or disease.
- Performance Studies: The performance studies focus on the physical barrier properties of the mask (filtration efficiency, fluid resistance, breathability, flammability, and biocompatibility), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s), and provided non-sterile.
Product codes
FXX
Device Description
The WellBefore 4 Layers disposable surgical mask is an adult-sized surgical mask equipped with earloops, designed to cower the user's nose and mouth. The surgical face masks are consists of Outer Layer(Non-woven fabric made from spunbond polypropylene), Second Layer(meltblown filtration fabric made from polypropylene), Third Layer(Electrostastic cotton made from ethylene-propylene side by side), Inner Layer(Non-woven fabric made from spunbond polypropylene), Nose Bridge(Double-wirenosepinmade by polypropylene, and Earloops(Polyster Fiber and Spandex). The mask acts as a physical barrier from fuids and particulate materials, and providing a level 3 barrier. It is a single-use, disposable device(s) , 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
adults
Intended User / Care Setting
patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment.
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 Test performed on the proposed device:
Study Type: Lab bench testing
Sample Size: Three lots tested
Key Results:
- Fluid Resistance Performance (ASTM F1862): 29 out of 32 pass at 160mmHg (level 3)
- Particulate Filtration Efficiency (ASTM F2299): ≥98%
- Bacterial Filtration Efficiency (ASTM F2101): ≥98% (actual result 99.9%)
- Differential Pressure (Delta P) (EN 14683:2019, Annex C):
§ 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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 2, 2023
Social Medical Supply LLC % Mr. Jett Lee Regulation Manager Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe district Guangzhou, Guangdong 510000 China
Re: K230093
Trade/Device Name: Disposable 4 Layers Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 12, 2023 Received: January 12, 2023
Dear Mr. Lee:
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
1
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 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,
Brent Showalter -S
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
Indications for Use
510(k) Number (if known) K230093
Device Name Disposable 4 layers surgical face mask
Indications for Use (Describe)
The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healtheare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the posure to blood and body fluids. It 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) | |
|---|---|
| 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
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a traditional 510(K) submission, and there were no prior submissions for the subject device.
1. Submitter's Information
Sponsor
- Company Name: SOCIAL MEDICAL SUPPLY LLC �
- � Address: 11528 Harry Hines Blvd, Suite A102 Dallas,TX75229
- � Tel:+1-214-416-9009 Fax:+1-214-416-9009
- Email: support@wellbefore.com �
- � Contact Person (including title): Shahzil Amin (General Manager)
Manufacturer
- Company Name: Jiangxi Xianmiyan Medical Technology Co., Itd �
- Address: South side of the Ganda line of Xiangtian industrial Park, Jing'an County, Yichun � City, Jiangxi Province, China
- Tel:+86-0754-87712777 Fax:+86-0754-87712777 �
- � Email: finnick@wellbefore.com
- Contact Person (including title): Finnick Lin(General Manager) �
Application Correspondent:
- � Guangdong Jianda Medical Technology Co Ltd
- Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China �
- � Contact Person: Mr. Jett Lee
- � Title: Regulation Manager
- � Tel: +86 13512755282
- Email: jianda-lee@foxmail.com �
2. Subject Device Information
- � Type of 510(k) submission: Traditional
- Classification/Common Name: Surgical Face Mask �
- Trade Name: Disposable 4 layers surgical face mask �
- Model: S1 �
- � Review Panel: Surgical Apparel
- � Product Code: FXX
4
- � Regulation Number: 878.4040
- � Requlation Class: 2
3. Predicate Device Information
- 510(k) number: K221272 �
- Sponsor: Shandong Xingyu Gloves Co., Ltd. �
- � Classification/Common Name: Surgical Face Mask
- � Trade Name: Surgical Face Mask
- � Model: Ear Loop
- � Review Panel: Surgical Apparel
- � Product Code: FXX
- � Regulation Number: 878.4040
- � Regulation Class: 2
4. Device Description
The WellBefore 4 Layers disposable surgical mask is an adult-sized surgical mask equipped with earloops, designed to cower the user's nose and mouth. The surgical face masks are consists of Outer Layer(Non-woven fabric made from spunbond polypropylene), Second Layer(meltblown filtration fabric made from polypropylene), Third Layer(Electrostastic cotton made from ethylene-propylene side by side), Inner Layer(Non-woven fabric made from spunbond polypropylene), Nose Bridge(Double-wirenosepinmade by polypropylene, and Earloops(Polyster Fiber and Spandex). The mask acts as a physical barrier from fuids and particulate materials, and providing a level 3 barrier. It is a single-use, disposable device(s) , provided non-sterile.
5. Intended Use / Indications for Use
The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s) , provided non-sterile.
6. Test Summary
1)Non-clinical Test performed on the proposed device
The Surgical Mask has been evaluated for its safety and performance by lab bench testing as following:
- Three lots tested according to ASTM F2100-19 standard �
| Performance requirement and test method recommended in ASTM F2100 | ||
|---|---|---|
| Item | Performance requirement | Test method |
| Fluid Resistance Performance | 29 out of 32 pass at 160mmHg | ASTM F1862 |
| Particulate Filtration Efficiency | $ \u226598% $ | ASTM F2299 |
5
| Bacterial Filtration Efficiency | $\u226598%$ | ASTM F2101 |
|---|---|---|
| Differential Pressure (Delta P) | $ |