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 provided nonsterile.

Device Description

The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with a nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.

AI/ML Overview

The provided text is for a 510(k) summary for a "Surgical Mask" and details a series of non-clinical (benchtop) performance tests and biocompatibility tests. It does not describe a study involving human readers or AI assistance. Therefore, some of the requested information regarding human-in-the-loop performance, multi-reader multi-case studies, and expert qualifications is not applicable.

Here's the breakdown of the acceptance criteria and performance data for the Surgical Mask:

1. Table of Acceptance Criteria and Reported Device Performance

Item	Purpose	Acceptance Criteria	Reported Device Performance
Benchtop Performance Testing
Resistance to Penetration by Synthetic Blood (ASTM F1862)	To demonstrate the Resistance to Penetration by Synthetic Blood ASTM F1862 of the subject device.	29 out of 32 pass at 160 mmHg	Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Lot 1: 32/32 passed. Lot 2: 32/32 passed. Lot 3: 32/32 passed.
Particulate Filtration Efficiency (ASTM F2299)	To demonstrate the Particulate Filtration Efficiency ASTM F2299 of the subject device.	≥ 98%	Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 passed. Lot 2: 32/32 passed. Lot 3: 32/32 passed.
Bacterial Filtration Efficiency (ASTM F2101)	To demonstrate the Bacterial Filtration Efficiency ASTM F2101 of the subject device.	≥ 98%	Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Lot 1: 32/32 passed. Lot 2: 32/32 passed. Lot 3: 32/32 passed.
Differential Pressure (EN 14683:2019)	To demonstrate the Differential Pressure EN 14683:2019 of the subject device.	< 6.0 mmH2O/cm²	Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at <6.0 H2O/cm². Lot 1: 32/32 passed. Lot 2: 32/32 passed. Lot 3: 32/32 passed.
Flammability (16 CFR 1610)	To demonstrate the Flammability 16 CFR 1610 of the subject device.	Class 1: < 3.5 second burn time	Three non-sequential lots of 32 (total of 96, AQL 4.0) passed Class 1 16 CFR 1610. Lot 1: 32/32 passed (DNI). Lot 2: 32/32 passed (DNI). Lot 3: 32/32 passed (DNI).
Biocompatibility Testing (ISO 10993-1:2018)
Cytotoxicity - ISO 10993-5		Non-Cytotoxic	Pass
Skin Sensitization - ISO 10993-10		Non- Sensitizing	Pass
Skin Irritation - ISO 10993-10		Non-Irritating	Pass

2. Sample size used for the test set and the data provenance

For each of the benchtop performance tests, the sample size was 96 devices, consisting of three non-sequential lots of 32 devices each. The data provenance is not specified beyond being "non-clinical performance testing" and conforming to specified standards, which typically implies laboratory testing. The country of origin of the data is not mentioned, and it is by nature prospective testing for the purpose of regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests are benchtop performance tests on physical devices, not image analysis or diagnostic studies requiring expert review for ground truth establishment.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against defined standards, not requiring adjudication of subjective interpretations.

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

Not applicable. This submission is for a physical medical device (surgical mask), not an AI-powered diagnostic tool. No human reader or AI assistance studies were conducted or are relevant.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For the benchtop physical performance tests, the "ground truth" is defined by the objective measurement standards outlined in the listed ASTM and EN standards (e.g., specific thresholds for particulate filtration efficiency, bacterial filtration efficiency, differential pressure, synthetic blood penetration, and flammability). For biocompatibility, the "ground truth" is based on the results of validated biological tests against the criteria of ISO 10993.

8. The sample size for the training set

Not applicable. This is for a physical device, not a machine learning model.

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

Not applicable. This is for a physical device, not a machine learning model.

Summary

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September 10, 2021

ReMade USA LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K212451

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 4, 2021 Received: August 5, 2021

Dear Prithul Bom:

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.

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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 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) K212451

Device Name Surgical Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Renovation that is Part of CER 331 Subpart D Construction that is CER 331 Subpart O
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__ Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K212451

This summary of 510(k) is submitted in accordance with the requirements of 21 CFR $807.92:

SUBMITTER .

ReMade USA LLC 2915 E Washington Blvd Los Angeles, CA 90023 USA Tel: +1.323.578.5448 Fax: N/A

Contact Person: David Durst Date Prepared: May 21, 2021

DEVICE II.

Name of Device:	Surgical Mask
Classification Name:	Surgical Mask
Regulation:	21 CFR §878.4040
Regulatory Class:	Class II
Product Classification Code:	FXX

. PREDICATE DEVICE

Predicate Manufacturer: Predicate Trade Name: Predicate 510(k):

DemeTECH Corporation Deme MASK Surgical Face Mask K201479

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device:

Device	Proposed Device	Predicate Device	Result
Manufacturer	ReMade USA LLC	DemeTECH Corporation	-
510K Number	K212451	K201479	-
ProductCommonName	SURGICAL MASK	DemeMASK Surgical Mask	Same
Product Code	FXX	FXX	Same
Classification	Class II (21 CFR 878.4040)	Class II (21 CFR 878.4040)	Same
Indications forUse	The disposable surgical facemasks are intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material.These face masks are intendedfor use in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device provided non-sterile.	The disposable surgical facemasks are intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material.These face masks are intendedfor use in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device provided non-sterile.	Same
Model	3 Ply, Ear Loops, Flat-PleatedStyle	3 Ply, Ear Loops/Tie-on, Flat-PleatedStyle	Similar
Materials
OuterFacingLayer	Spunbond Polypropylene 25gsm	Spunbond Polypropylene	Same
Middle Layer	Melt Blown PolypropyleneFilter 25gsm	Melt Blown PolypropyleneFilter	Same
Inner FacingLayer	Spunbond Polypropylene 25gsm	Spunbond Polypropylene	Same
Nose Piece	Single Galvanized Iron Wire,coated with Polypropylene$3.0mm\pm1.0mm$ Length/1$\pm0.1mm$ Thick/ $0.5\pm0.01mm$Diameter	Galvanized wire coated with PE(Dimensions Unknown)	Similar
Ear Loops	80% Nylon; 20% SpandexLength: $4.0mm\pm0.15$ , Thickness:$1.0mm\pm0.15mm$	Polyester spandex blend	Similar
Color	Blue	White	Different
Dimension(Width)	$9.5 cm \pm 1cm$	$9.5cm \pm 1cm$	Same
Dimension(Length)	$17.5 cm \pm 1cm$	$17.5cm \pm 1cm$	Same
OTC Use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use	Single Use	Same
ASTM F2100Level	Level 3 – ASTM F2100-19	Level 3 – ASTM F2100-19	Same

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VII. SUMMARY of NON-CLINICAL PERFORMANCE TESTING

The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2.

Item	Purpose	Acceptance Criteria	Subject Device - ReMadeSurgical Mask
Level 3Resistance toPenetration bySynthetic BloodSTM F1862	The purpose ofthis testing is todemonstratethe Resistanceto Penetrationby SyntheticBlood ASTMF1862 of thesubject device.	29 Out of 32pass at 160 mmHg	Three non-sequential lotsof 32 (total of 96, AQL4.0) passed at 160mmHgLot 1: 32/32 passed.Lot 2: 32/32 passed.Lot 3: 32/32 passed

Table 2 – Benchtop Performance Testing

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ParticulateFiltrationEfficiency ASTMF2299	The purpose ofthis testing is todemonstrate theParticulateFiltrationEfficiency ASTMF2299 of thesubject device.	≥ 98%	Three non-sequential lots of 32(total of 96, AQL 4.0) passed at≥98%Lot 1: 32/32 passed.Lot 2: 32/32 passed.Lot 3: 32/32 passed
BacterialFiltrationEfficiency ASTMF2101	The purpose of thistesting is todemonstrate theBacterial FiltrationEfficiency ASTMF2101 of the subjectdevice.	≥ 98%	Three non-sequential lots of 32(total of 96, AQL 4.0) passed at≥98% - ASTM F2101Lot 1: 32/32 passed.Lot 2: 32/32 passed.Lot 3:32/32 passed
DifferentialPressure EN14683:2019	The purposeof this testingis todemonstratetheDifferentialPressure EN14683:2019of the subjectdevice.	< 6.0mmH20/cm²	Three non-sequential lots of 32(total of 96, AQL 4.0) passed at<6.0 H2O/cm2Lot 1: 32/32 passed.Lot 2: 32/32 passed.Lot 3: 32/32 passed.
Class 1Flammability 16CFR 1610	The purpose of thistesting is todemonstrate theFlammability 16CFR 1610 of thesubject device.	Class 1:< 3.5 second burn time	Three non-sequential lots of 32(total of 96, AQL4.0) passed Class 1 16CFR 1610Lot 1: 32/32 passed (DNI)Lot 2: 32/32 passed (DNI)Lot 3: 32/32 passed (DNI)

Sterilization & Shelf-life Testing

Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)

Biocompatibility Testing

Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.

Biocompatibility Testing Endpoints	Acceptance Criteria	Result
Cytotoxicity - ISO 10993-5	Non-Cytotoxic	Pass
Skin Sensitization - ISO 10993-10	Non- Sensitizing	Pass
Skin Irritation - ISO 10993-10	Non-Irritating	Pass

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Table 4 - Summary of Non-Clinical Performance Testing

The following standards have been used to evaluate the ReMade USA Surgical Mask:

ASTM F2100	Standard Specification for Performance of Materials Used in MedicalFace Masks
ASTM F1862	Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of Fixed Volumeat a Known Velocity)
ASTM F2299	Standard Test Method for Determining the Initial Efficiency of MaterialsUsed in Medical Face Masks to Penetration by Particulates Using LatexSpheres
ASTM F2101	Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE)of Medical Face Mask Materials, Using a Biological Aerosol ofStaphylococcus aureus
EN 14683:2019	Standard Test Method for Differential Pressure
16 CFR Part 1610	Standard for Flammability
ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process
ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity of medical devices
ISO 10993-10	Biological evaluation of medical devices - Part 10: Tests for irritation andskin sensitization

Software Verification and Validation Testing

Not Applicable (Passive Device)

Electrical safety and electromagnetic compatibility (EMC)

Not Applicable (Passive Device)

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

VIII. CONCLUSIONS

The conclusions drawn from the performance data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device K201479, DemeMASK Surgical Face Mask manufactured by DemeTECH Corporation.

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.