BAYLAB 3-Ply Surgical Masks (BEACON I) 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.

Device Description

BAYLAB 3-Ply Surgical Masks (BEACON I) are nonwoven, pleated, 3-ply, single use, disposable flat surgical masks, manufactured in Bay Blue color. The surgical masks are to be secured on users by means of elastic ear loops.

AI/ML Overview

This is a 510(k) premarket notification for a surgical mask (BAYLAB 3-Ply Surgical Mask (BEACON I)). The document describes the acceptance criteria and performance of the device based on non-clinical testing.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (Level 3)	Reported Device Performance
Bacterial Filtration Efficiency (BFE) (ASTM F2101)	≥98%	Pass at >98%
Differential Pressure (ΔP) (EN 14683)	<6mm H2O/cm²	ΔP <6mm H2O/cm²
Sub-micron Particulate Filtration Efficiency (PFE) (ASTM F2299)	≥98%	Pass at >99%
Resistance to penetration by Synthetic Blood (ASTM F1862)	160mm Hg	Pass at 160mm Hg
Flammability (16 CFR Part 1610)	Class 1	Class 1
Cytotoxicity (ISO 10993-5)	Non-cytotoxic	Pass - non-cytotoxic
Irritation (ISO 10993-10)	Non-irritating	Pass - non-irritating
Sensitization (ISO 10993-10)	Non-sensitizing	Pass - non-sensitizing

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each test. For the performance tests (BFE, ΔP, PFE, Synthetic Blood Penetration, Flammability) and biocompatibility tests (Cytotoxicity, Irritation, Sensitization), it states that tests were conducted according to the respective ASTM, EN, and ISO standards. These standards typically define minimum sample sizes for testing, but the specific number tested for this device is not reported in this summary. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated, but these are standard laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to the evaluation of a surgical mask. The acceptance criteria are based on objective, standardized physical and biological tests, not on expert interpretation or subjective ground truth from medical professionals.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable as the evaluation involves objective laboratory tests with clearly defined pass/fail criteria, so there is no subjective adjudication required.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. Surgical masks are not diagnostic devices that involve human readers or AI assistance.

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

This is not applicable as the device is a physical product (surgical mask) and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is established by objective, standardized laboratory test methods defined in the referenced national and international standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards contain specific protocols and acceptance criteria for measuring filtration efficiency, breathability, fluid resistance, flammability, and biological safety.

8. The sample size for the training set

This is not applicable. The device is a manufactured item, not an AI/machine learning model, so there is no training set in this context.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set.

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). 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 7, 2021

Baylab USA, LLC % Vardhini Kirthivas Vice President - Regulatory Services Freyr Solutions Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli Hyderabad, Telangana 500081 India

Re: K212302

Trade/Device Name: BAYLAB 3-Ply Surgical Mask (BEACON I) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: November 9, 2021 Received: November 10, 2021

Dear Vardhini Kirthivas:

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,

For Clarence W. Murray III, PhD 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

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Indications for Use

510(k) Number (if known) K212302

Device Name BAYLAB 3-Ply Surgical Masks (BEACON I)

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)

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Phone: E-mail:

510(k) Summary K212302

1. Submitter Information:

Application Correspondent (US Agent):

Vardhini Kirthivas Freyr Global Regulatory Solutions and Services Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli, Hyderabad, Telangana, India, 500081 +91 - 9940445965 vardhini.kirthivas@FreyrSolutions.com

Legal Manufacturer:	BAYLAB USA LLC
Phone:	214-907-2527
Contact Person:	Ashley Park
E-mail:	Ashley.park@baylabusa.com
Fax Number (including area code):	469-372-0414
Date Prepared:	22-June-2021

2. Device Identification:

Device Trade Name:	BAYLAB 3-Ply Surgical Masks (BEACON I)
Device:	Mask, Surgical
Regulation Description:	Surgical Apparel
Regulation Medical Specialty:	General & Plastic Surgery
Review Panel:	General Hospital
Device Class:	II
Regulation Number:	878.4040
Product Code:	FXX

3. Predicate Devices:

Table 1 - List of Predicate Devices

Device Name	510(k) Number
DemeMASK	K201479

4. Device Description

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5. Intended Use & Indications for Use

BAYLAB 3-Ply Surgical Masks (BEACON I) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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 nonsterile.

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6. Comparison of Technological Characteristics

Table 2 – Comparison Table

S.No	Parameters		Predicate Device	Subject device	Comments
1.	Name		DemeMASK	BAYLAB 3-Ply Surgical Masks (BEACON I)	N/A
2.	510(k) Number		K201479	K212302	N/A
3.	Manufacturer		DemeTECH Corporation	BAYLAB USA LLC	N/A
4.	Product Code		FXX	FXX	Same
5.	Regulation Number		878.4040	878.4040	Same
6.	Intended Use/Indications of Use		The Disposable Surgical Face Masks areintended to be worn to protect both the patientand healthcare personnel from transfer ofmicroorganisms, body fluids and particulatematerial. These face masks are intended for usein infection control practices to reduce thepotential exposure to blood and body fluids.This is a single use, disposable device providednonsterile.	BAYLAB 3-Ply Surgical Masks (BEACON I) areintended to be worn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids and particulate material.These surgical masks are intended for use ininfection control practices to reduce the potentialexposure to blood and body fluids. This is a singleuse, disposable device provided nonsterile.	Same
7.	Material ofConstruction	Inner Layer	Spun-bond Polypropylene	Spunbond polypropylene	Same
		Outer Layer	Spun-bond Polypropylene	Spunbond polypropylene	Same
		Middle Layer	Meltblown polypropylene filter	Meltblown polypropylene filter	Same
		Ear loops	Spandex and Nylon- Not made with naturalrubber latex	Spandex, Nylon, Polyester - Not made with naturalrubber latex	Different,Note 1
		Nose Piece	Galvanized wire coated with polyethylene	Plastic (polyethylene) clad aluminum	Different,Note 2
8.	Dimensions		Length: 17.5 cm±1 cmWidth: 9.5 cm±1 cm	Mask size: 7" x 3 ¾" (17.78 cm x 9.525 cm)	Same
9.	Color		Blue	Blue	Same
10.	Mask Style		Flat - pleated	Flat pleated, 3-ply	Same
11.	Design Features		Ear loop	Ear loop	Same
12.	Sterility		Non - Sterile	Non- Sterile	Same
13.	Use		Single Use	Single Use	Same
S.No	Parameters	Predicate Device	Subject device	Comments
14.	Latex	Not made with Natural Rubber Latex	Not made with Natural Rubber Latex	Same
15.	ASTM F2100 Level	Level 3	Level 3	Same
16.	Bacterial filtration efficiency	Pass at ≥ 99%(ASTM F2101)	Pass at >98%(ASTM F2101)	Different,Note 3
17.	Differential pressure (Delta-P)	Average 3.6 mmH2O/cm²(MIL-M-36954C)	ΔP <6mm H2O/cm²(EN 14683)	Different,Note 4
18.	Sub-micron particulate filtration efficiency	Pass at ≥99%(ASTM F2299)	Pass at >99%(ASTM F2299)	Similar,Note 5
19.	Resistance to penetration bysynthetic blood, minimum pressurein mm Hg for pass result	Pass at 160 mm Hg (ASTM F1862)	Pass at 160 mm Hg (ASTM F1862)	Same
20.	Flammability	Class 1 (16 CFR Part 1610)	Class 1 (16 CFR Part 1610)	Same
21.	Biocompatibility Cytotoxicity,ISO 109935:2009	Pass ISO 10993-5:2009/ under the conditions ofstudy the subject device was non-cytotoxic.	Pass ISO 10993-5:2009/ under the conditions ofstudy the subject device was non-cytotoxic.	Same
	Biocompatibility Irritation,ISO 10993-10:2010	Pass ISO 10993-10:2010/ under the conditionsof the study, the subject device was non-irritating.	Pass ISO 10993-10:2010/ under the conditions of thestudy, the subject device was non-irritating.	Same
	Biocompatibility Sensitization,ISO 10993-10:2010	Pass ISO 10993-10:2010/ under the conditionsof study, the subject device was non-sensitizing.	Pass ISO 10993-10:2010/ under the conditions ofstudy, the subject device was non-sensitizing.	Same

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Note 1 & Note 2: The differences in the materials do not raisety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials.

Note 3: The performance requirement for BFE as per ASTM F2100 is ≥98%. The performance of the requirements of ASTM F2100 version 2020 which is the revised version of FDA recognized consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria.

Note 4: We understand that MIL-M-36954C is the FDA recommended standard for differential pressure, However, the conformance to FDA Recognized consensus standard [Rec# 6-425], ASTM F2100-19 requires that Differential pressure be performed as per EN 14683:2019, Anex C.

We also understand that as per ASTM F2100-19, passing criteria for an ASTM level 3 mask with respect to differential pressure is <6.0mm HJVcm² when tested in accordance with EN 14683:2019. Annex C. The subject device meets the criteria.

Note 5: The performance requirement for PFE as per ASTM F2100 is ≥98% when tested in accordance with ASTM F2299. The performance of the subject device meets the requirements of ASTM F2100 version 2020 which is the revised consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria.

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Traditional 510(k) BAYLAB 3-ply Surgical Masks (BEACON I)

7. Non-Clinical Testing

The following performance tests, in accordance with ASTM F2100 were conducted for the subject device:

. ASTM F1862 Standard test method for resistance of medical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
16 CFR Part 1610 Standard for The Flammability of Clothing Textiles
EN 14683:2019+AC:2019 Medical face masks Requirements and test methods ● Annex C - Method for determination of breathability (differential pressure)
ASTM F2299- Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus aureus.

Sr. No.	Test Method/Standard	Purpose	Acceptancecriteria	Results
1.	ASTM F 2101	Bacterial filtration efficiency	Level 3: ≥98%	Pass at >98%
2.	EN 14683	Differential Pressure (Delta-P)	Level 3: ΔP <6mm H2O/cm2	ΔP <6mm H2O/cm2
3.	ASTM F2299	Sub-micron particulatefiltration efficiency	Level 3: ≥98%	Pass at >99%
4.	ASTM F1862	Resistance to penetration bysynthetic blood	Level 3: 160mmHg	Pass at 160mm Hg
5.	16 CFR Part 1610	Flammability	Class I	Class I

Table 3 - Performance Testing - summary

FDA's guidance, "Surgical Masks - Premarket Notification [510(k)] Submissions ", recommends evaluating the biocompatibility as described in the standard ISO10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for limited contact devices, contacting intact skin.

The following Biocompatibility End points have been identified and tested in accordance appropriate biocompatibility standards.

Cytotoxicity (ISO 10993-5) -
Irritation or intracutaneous reactivity (ISO 10993-10) -
-Sensitization (ISO 10993-10)

Biologicalendpoint	TestMethod	Purpose	Acceptancecriteria	Test Result
Cytotoxicity	ISO10993-5	VerifyCytotoxicitypotential of thesubject device	Non-cytotoxic	Pass - ISO 10993-5:2009/ under theconditions of study the subjectdevice was non-cytotoxic.
Irritation andSensitization	ISO10993-10	Verify irritationand sensitization	Non-irritatingand non-sensitizing	Pass ISO 10993-10:2010/ under theconditions of the study, the subject

Table 4 - Biocompatibility Testing - summary

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Traditional 510(k) BAYLAB 3-Ply Surgical Masks (BEACON I)

	potential of the	device was non-irritating and non-
	subject device	sensitizing.

8. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, DemeMASK cleared under K201479.

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.