The Surgical Masks are 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, provided non-sterile.

Device Description

The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.

AI/ML Overview

This document describes the performance testing for the Bain Medical Equipment (Guangzhou) Co., Ltd. Surgical Masks (K203524).

1. Table of Acceptance Criteria and Reported Device Performance

Name of the Test / Methodology / Standard	Purpose	Acceptance Criteria	Results
Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M-17)	To evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids.	No penetration at 120 mmHg	Pass at 120mmHg
Bacterial Filtration Efficiency (ASTM F2101-2019)	To determine the bacterial filtration efficiency (BFE) of medical face mask materials, using a biological aerosol of Staphylococcus aureus.	≥98%	Average 99.9%
Particulate Filtration Efficiency (ASTM F2299/F2299M-03 (2017))	To determine the Particle Filtration Efficiency of materials used in medical face masks to penetration by particulates using latex spheres.	≥98%	Average 98.8%
Differential Pressure (EN 14683:2019)	To determine the differential pressure.	<6.0 mm H2O/cm²	Average 4.5 mm H2O/cm²
Flammability (16 CFR 1610)	To evaluate the flammability of the test sample.	Class I	Class I

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

The document does not explicitly state the specific sample size used for each test. However, it indicates that the tests were performed in accordance with recognized international standards (ASTM, EN, CFR), which typically specify sample sizes for such evaluations. The data provenance is from non-clinical testing conducted by Bain Medical Equipment (Guangzhou) Co., Ltd., as part of their 510(k) submission to the FDA. The country of origin for the data is implicitly China, where Bain Medical Equipment (Guangzhou) Co., Ltd. is located. It is retrospective in the sense that the testing was performed and the results are being reported for regulatory submission.

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

Not applicable. This report details non-clinical laboratory performance testing of a medical device (surgical masks), not a diagnostic or AI-based device requiring human expert consensus for ground truth. The "ground truth" for these tests is established by the specified methodology and measurement against the defined acceptance criteria in the respective standards.

4. Adjudication Method for the Test Set

Not applicable, as this is laboratory performance testing against established standards, not a clinical study involving human assessment or adjudication of outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (surgical masks) which is evaluated through non-clinical performance testing against established standards, not through clinical comparative effectiveness studies with human readers or AI assistance.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective measurements and defined acceptance criteria outlined in specific industry standards and regulations (e.g., ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610). These standards dictate the methodology and expected outcomes for each performance characteristic of a surgical mask.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 25, 2021

Bain Medical Equipment (Guangzhou) Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China

Re: K203524

Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 10, 2020 Received: December 1, 2020

Dear Diana Hong:

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 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 CAPT Elizabeth Claverie, M.S. 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) K203524

Device Name Surgical Masks

Indications for Use (Describe)

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."

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

{3}------------------------------------------------

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

1. Date of Preparation: 01/29/2021
1. Sponsor Identification

Bain Medical Equipment (Guangzhou) Co., Ltd.

No.10 Juncheng Road, Eastern Area, Economic & Technological Development District, Guangzhou, China, 510760

Establishment Registration Number: 3013217742.

Contact Person: Mu Fangzhen Position: Management Representative Tel: +86-20-66856868 ext.287 Fax: +86-20-32067500 Email: mufangzhen@baingz.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

{4}------------------------------------------------

4. Identification of Proposed Device

Trade Name: Surgical Masks Common Name: Surgical Face Mask Size: 17.5cm×9.5cm

Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Indication for use:

Device Description:

The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.

ર. Identification of Predicate Device
510(k) Number: K153496 Product Name: Disposable Surgical Face Mask

6. Summary of Non-Clinical Testing

The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.

{5}------------------------------------------------

K203524

Name of the TestMethodology / Standard	Purpose	Acceptance Criteria	Results
Resistance to Penetrationby Synthetic bloodASTM F1862/F1862M-17 Standard Test Methodfor Resistance of MedicalFace Masks toPenetration by SyntheticBlood (HorizontalProjection of FixedVolume at a KnownVelocity)	The test was performed inaccordance with ASTMF1862-17 Standard TestMethod for Resistance ofMedical Face Masks toPenetration by SyntheticBlood (HorizontalProjection of Fixed Volumeat a Known Velocity) toevaluate the effectiveness ofthe test sample frompossible exposure to bloodand other body fluids	No penetration at120 mmHg	Pass at120mmHg
Bacterial FiltrationEfficiencyASTM F2101-2019Standard Test Method forEvaluating the BacterialFiltration Efficiency(BFE) of Medical FaceMask Materials, Using aBiological Aerosol ofStaphylococcus aureus	The test was performed inaccordance with ASTMF2101-19 Standard TestMethod for Evaluating theBacterial FiltrationEfficiency (BFE) of MedicalFace Mask Materials, usinga Biological Aerosol ofStaphylococcus aureus todetermine the bacterialfiltration efficiency (BFE) ofthe test article.	≥98%	Average 99.9%
Particulate FiltrationEfficiencyASTM F2299/F2299M-03 (2017) Standard TestMethod for Determiningthe Initial Efficiency ofMaterial Used in medicalFace Masks toPenetration byParticulates using LatexSpheres	The test was performed inaccordance with ASTMF2299-03 (Reapproved2017) Standard Test Methodfor Determining the InitialEfficiency of Materials Usedin Medical Face Masks toPenetration by ParticulatesUsing Latex Spheres, todetermine the ParticleFiltration Efficiency	≥98%	Average 98.8%
Differential PressureEN 14683:2019 Medicalface masks-Requirements and testmethods	The test was performed inaccordance with EN14683:2019 Medical facemasks-Requirements andtest methods, to determinethe differential pressure.	<6.0 mm H2O/cm²	Average 4.5 mmH2O/cm²
Flammability16 CFR 1610 Standardfor the Flammability ofClothing TextilesCorrections	The test was performed inaccordance with 16 CFR1610 STANDARD FORTHE FLAMMABILITY OFCLOTHING TEXTILES toevaluate the flammability ofthe test sample.	Class I	Class I

Table 1 Performance Testing

{6}------------------------------------------------

1. Clinical Test Conclusion
  No clinical study is included in this submission.

{7}------------------------------------------------

Summary of Technological characteristics 8.

ITEM	Proposed Device K203524	Predicate Device K153496	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indication for Use	The Surgical Masks are 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, provided non-sterile.	The Disposable Surgical Face Masks are 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.	Same
Mask style	Flat-pleated	Flat-pleated	Same
Design feature	Ear loop	Ear loop/Tie-on	Different 1
Layers	Three	Three	Same
Color	Blue	Blue	Same
Dimension (cm)	17.5cm×9.5cm	17.5cm×9.5cm	Same
Level	Level 2	Level 2	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
Shelf life	2 years	Unknown	Different 2
Fluid resistanceASTM F1862	Pass at 120mmHg	Pass at 120mmHg	Same
Particulate filtration efficiencyASTM F2299	≥98%	≥98%	Same
Bacterial filtration efficiencyASTM F2101	≥98%	≥98%	Same
Differential pressure	<6.0mmH2O/cm2EN 14683	4.0 mmH2O/cm2MIL-M-36954C	Different 3
Flammability16 CFR Part 1610	Class 1	Class 1	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Patient Contacting Material
Outer facing layer	Spunbond Polypropylene	Spun-bond polypropylene
Middle layer	Melt-blownPolypropyleneFilter	Melt blown polypropylene filter
Inner facing layer	Spunbond Polypropylene	Spun-bond polypropylene	Different 4
Nose clip	Polyethylene andGalvanizedIron	Malleable aluminum wire
Ear loop	Polyester and Spandex	Polyester
Biocompatibility
Cytotoxicity	Comply with ISO 10993-5;Under the conditions ofthestudy, not cytotoxicity effect.	Under the conditions of the study,not cytotoxicity effect.	Same
Sensitization	Comply with ISO 10993-10;Under the conditions of thestudy, not an irritant.	Under the conditions of the study,not an irritant.	Same
Irritation	Comply with ISO 10993-10;Under conditions of the study,not a sensitizer.	Under conditions of the study, nota sensitizer.	Same

Table 2 Comparison of Technology Characteristics

{8}------------------------------------------------

Different 1 - Design feature

The predicate devices are available in two types, ear loop type and tie-on type. The proposed device is only an ear loop mask and its type is included in the predicate device. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different 2 - Shelf life

Shelf life will affect the safety and effectiveness of mask. However, the performance testing of the proposed device after two years of aging has been conducted and the test results show that the proposed device after two years of aging meets the requirements of ASTM F2100-2019. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different 3 - Differential pressure

The differential pressure test standards used for the proposed device and predicate device are different. The differential pressure testing for the proposed device was conducted according to Annex C of EN 14683. While the differential pressure testing for the predicate device was conducted according to MIL-M-36954C. The differential pressure test standard specified in ASTM F2100-19 standard is Annex C of EN 14683. In addition, the proposed device has been tested for differential pressure using EN 14683 test method, and the test results meet the requirements of ASTM F2100-19 standard. Thus, this difference will not affect the safety and effectiveness of the proposed devices.

{9}------------------------------------------------

Different 4 - Patient Contacting Material

The patient contacting material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the proposed device.

1. Conclusion
  The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe as effective, and performs as well as or better than the legally marketed predicate device K153496.

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.