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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Disposable 4 layers surgical face mask based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Requirement (Acceptance Criteria)	Test Method	Reported Device Performance (Proposed Device)	Outcome
Fluid Resistance: $\ge 29$ out of 32 pass at 160mmHg (level 3)	ASTM F1862	At least 29 out of 32 passing at 160mmHg	Pass
Particulate Filtration Efficiency: $\ge 98%$	ASTM F2299	$\ge 98%$	Pass
Bacterial Filtration Efficiency: $\ge 98%$	ASTM F2101	$99.9%$	Pass
Differential Pressure (Delta P): $< 6.0$ mmH2O/cm$^2$	EN 14683:2019, Annex C	$< 6.0$ mmH2O/cm$^2$	Pass
Flammability: Class 1 (Non Flammable)	16 CFR 1610	Class 1 (Non Flammable)	Pass
Biocompatibility: Non-cytotoxic, non-irritating, non-sensitizing	ISO 10993-5, ISO 10993-10	Met ISO10993 (proved non-cytotoxicity, non-irritating, and non-sensitizing)	Pass

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: For performance testing (Fluid Resistance, PFE, BFE, Differential Pressure), three lots of the device were tested. Specific sample sizes within each test are mentioned (e.g., 32 for Fluid Resistance), but a total number of individual masks tested across all lots is not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data for these performance tests. It states that the tests were performed by "lab bench testing." The manufacturer is located in China (Jiangxi Xianmiyan Medical Technology Co., Itd).
Retrospective or Prospective: The device testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as the tests described are performance and material characteristic tests (bench testing) and not based on expert-established ground truth.

4. Adjudication Method for the Test Set

This is not applicable for bench testing. The results are quantitative measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for AI/imaging devices involving human interpretation. This document pertains to a surgical face mask, which does not involve human readers or AI assistance in its primary function or evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is not applicable for a surgical face mask.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the specified performance requirements and test methods outlined in recognized standards such as ASTM F2100-19, EN 14683:2019, 16 CFR 1610, and ISO 10993 series. These standards define the expected performance metrics (e.g., filtration efficiency percentages, pressure differential limits) and the laboratory procedures for measuring them.

8. The Sample Size for the Training Set

Not applicable. There is no AI or algorithm involved in this medical device that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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

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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

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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)

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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

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� 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

5. Intended Use / Indications for Use

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

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Bacterial Filtration Efficiency	$\u226598%$	ASTM F2101
Differential Pressure (Delta P)	$< 6.0 mmH2O/cm²$	EN 14683:2019, Annex C
Flammability	Class 1	16 CFR 1610

� Biocompatibility test according to ISO 10993-1 standard
- 1. Cytotoxicity Test with MTT Method according to ISO 10993-5
- 1. Skin Irritation Test with test method: 0.9% Sodium Chloride Injection Extract and Soybean Oil Extract according to ISO 10993-10
- 1. Skin Sensitization with test method: 0.9% Sodium Chloride Injection Extract and Soybean Oil Extract according to ISO 10993-10

Performance testing result

PerformanceTesting Items	Test result	Criteria	Remark
Fluid ResistancePerformanceASTM F1862	3 lots with at least 29 out of 32passing at 160mmHg (level 3)	3 lots with at least 29 out of 32passing at 160mmHg (level 3)	Pass
Particulate FiltrationEfficiencyASTM F2299	3 lots at ≥98%	3 lots at ≥98%	Pass
Bacterial FiltrationEfficiencyASTM F2101	3 lots at 99.9%	3 lots at ≥98%	Pass
DifferentialPressure (Delta P)EN 14683:2019,Annex C	3 lots passing atat <6.0 mmH₂O/cm²	3 lots passingat <6.0 mmH₂O/cm²	Pass
Flammability16 CFR 1610	Class 1Non Flammable	Class 1Non Flammable	Pass
Biocompatibility	Cytotoxicity/Irritation/Sensitization according to ISO10993-5;ISO10993-10	Cytotoxicity/Irritation/Sensitization according to ISO10993-5;ISO10993-10	Pass

2) Clinical Test Conclusion

No clinical study is included in this submission.

7. Summary of Technological Characteristic

The technological characteristics, features, specifications, materials, and intended use of Surgical Mask is similar to the predicate device quoted above. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

Device	Proposed Device	Predicate Device	Comparison
510(K)	Apply	K221272	--
Sponsor	SOCIAL MEDICAL SUPPLY LLC	Shandong Xingyu Gloves Co., Ltd.	--
Manufacturer	Jiangxi Xianmiyan Medical	Shandong Xingyu Gloves Co., Ltd.	--

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Technology Co., ltd
Product Name		Disposable 4 layers surgical facemask	Surgical Face Mask	--
Classification		Class II, FXX (21 CFR878.4040)	Class II, FXX (21 CFR878.4040)	Same
Intended Use		The Disposable 4 layers surgicalface mask is intended to be wornby adults, and protects bothpatients and healthcare personnelfrom microorganisms, body fluidsand particulate material transferwithin a professional healthcareenvironment. The mask isdesigned for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. It is a single-use,disposable device(s), providednon-sterile.	The Medical Face Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This asingle use, disposable device(s),provided non-sterile.	substantiallyequivalent
Material	Outer Layer	Non-woven fabric (spunbond PP)	Non-woven fabric	Same
	Middle Layer	Second Melt blown polypropylenefilterThird Electrostatic cotton madeLayer from ethylene-propylene	Melt-blown Non-woven fabric	DifferentNote1

	Inner FacingLayer	Non-woven fabric	Non-woven fabric	Same
	Noise Piece	Malleable polyethylene wire	Metal Core Plastic(Iron wire & Polypropylene)	Same
Ear Loops		Polyster and Spandex	Polyster and Spandex	Same
Color		Blue	Blue, Black	DifferentNote2
Dimension		17.7cm*9.5cm, ±1cm tolerance	17.5cm*9.5cm, ±0.5cm tolerance	DifferentNote2
OTC Use		Yes	Yes	Same
Sterility		Non-Sterile	Non-Sterile	Same
Use		Single Use, Disposable	Single Use, Disposable	Same
PerformanceTesting (ASTMF2100)		Level 2 & 3	Level 2 & 3	Same
Fluid ResistancePerformanceASTM F1862		29 out of 32 pass at 120mmHg	32 out of 32 pass at 120mmHg	DifferentNote3
Particulate FiltrationEfficiencyASTM F2299		≥98%	≥98%	Same
Bacterial FiltrationEfficiencyASTM F2101	$\ge$ 98%	$\ge$ 98%	Same
DifferentialPressure (Delta P)	<6.0 mmH2O/cm²	<6.0 mmH2O/cm²	Same
Flammability16 CFR 1610	Class 1Non Flammable	Class 1Non Flammable	Same
Biocompatibility	Meet ISO10993 ,provednoncytotoxicity, non-irritating andnon-sensitizing	Meet ISO10993 ,provednoncytotoxicity, non-irritating andnon-sensitizing	Same

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Comparison in Detail(s):

Note 1:

The difference in the middel layer material and layer numbers does not raise additional questions for safety and effectiveness. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. Performance tests were in accordance with ASTM F2100 standard. There is no new risk generated from the difference of the material and layer number .

Note 2:

The difference in the dimensions and colors does not raise additional questions for safety and effectiveness. The dimensions of proposed device is design for adults. Performance testing including biocompatibility evaluation has been performed on the finished device which includes all construction materials and color additives.

Note 3:

The difference in Fluid Resistance Performance ASTM F1862 is does not raise additional questions for safety and effectiveness.

8. Summary for clinical test

Clinical performance is not deemed necessary.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed devices identified.

Regulation Number and Section

§ 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.