The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This is a single use, disposable device provided non-sterile.

Device Description

The KDI Med Supply surgical face mask is with blue outer color layer and white inner and middle layer. Subject device is a flat pleated type mask, utilizing ear loop way for wearing, and it has a nose piece designed for fitting the face mask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner layer (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The masks contains a malleable nose piece to provide a firm fit over the nose and to secure the mask over the users mouth and face. The mask has level II fluid resistance under ASTM F2100. The mask is a single use, provided nonsterile. This product contains no components made with natural rubber latex.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, specifically for the "3 Ply Medical Grade Single Use Procedural Disposable Face Mask (K220637)".

The device is a medical face mask, and its acceptance criteria are based on established standards for such devices. The studies conducted are benchtop performance tests comparing the subject device to a predicate device and evaluating its performance against specific ASTM and ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology, Standard	Purpose	Acceptance Criteria	Reported Device Performance (Results)
ASTM F1862	Resistance to Penetration by Synthetic Blood	120 mm Hg (Pass/Fail)	120 mm Hg (32 out of 32 pass)
ASTM F2299	Particulate Filtration Efficiency (PFE)	>98%	>99.99%
ASTM F2101	Bacterial Filtration Efficiency (BFE)	>98%	>99.9%
ASTM F2100 (Differential Pressure)	Differential Pressure (Delta-P)	< 6.0 mm H2O/cm²	< 6.0 mm H2O/cm² (8 L/min)
16 CFR 1610	Flammability	Class 1	Class 1
ISO 10993-10	Irritation	No significant irritation	PASS
ISO 10993-10	Sensitization	No significant sensitization	PASS
ISO 10993-5	Cytotoxicity	No significant cytotoxicity	PASS

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

The provided document indicates that performance data was provided from "3 nonconsecutive lots" to demonstrate that the subject device meets the criteria. The specifics of the number of masks tested per lot for each particular test are not explicitly detailed in this document.

The data provenance is non-clinical benchtop testing, performed for regulatory submission in the USA (FDA). It is retrospective in the sense that the tests were conducted on manufactured samples to demonstrate compliance.

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

This type of study (benchtop performance testing for medical masks) does not typically involve human experts to establish ground truth in the way medical imaging or diagnostic studies do. The "ground truth" is established by the specifications of the ASTM and ISO standards themselves, which are scientifically validated and widely accepted test methodologies implemented by trained laboratory technicians.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is determined by the physical and chemical properties of the device as measured by standardized tests, not by expert consensus or adjudication. The tests have predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved. For a surgical face mask, the assessment relies on objective benchtop performance metrics.

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

This question is not applicable to a physical medical device like a face mask. "Standalone" performance typically refers to the performance of an AI algorithm without human input or review. The evaluation of this face mask is entirely based on its physical and material properties as measured by laboratory tests.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is standardized test results against established medical device performance standards (ASTM and ISO). These standards define the acceptable physical and material properties for surgical masks, such as filtration efficiency, fluid resistance, flammability, and biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device (face mask), not a software or AI-driven device. Therefore, there is no "training set" in the context of machine learning or algorithm development. The "training" for such a device would refer to its manufacturing process and quality control to ensure consistency.

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

Not Applicable. As there is no training set in the context of an algorithm, the concept of establishing ground truth for a training set does not apply.

Summary

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

March 25, 2022

KDI Med Supply % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K220637

Trade/Device Name: 3 Ply Medical Grade Single Use Procedural Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: March 3, 2022 Received: March 4, 2022

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 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.

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) K220637

Device Name

3 Ply Medical Grade Single Use Procedural Disposable Face Mask

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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Image /page/3/Picture/0 description: The image shows the logo for KDI Med Supply, which features a blue square, a gray square, and a dark blue square with a white plus sign in the middle. To the right of the squares is the text "KDI MED SUPPLY" in gray, blue, and black. To the right of the logo is a blue face mask with white ear loops and a "Made in USA" logo.

510(k) SUMMARY - K220637

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

Type of Submission: Traditional

Date Prepared: 3/24/2022

Device Type: Surgical Mask

l. SUBMITTER

KDI Med Supply 206 Lynn St. Fremont, OH 43420 USA Phone: (567) 280-9936 or (419) 307-0305 Fax: N/A

Contact Person: Yolanda Davis Email: kevin@kdimedsupply.com

ll. SUBJECT DEVICE

Device/Trade Name:	3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Classification Name:	Mask, Surgical
Regulation:	21 CFR 878.4040
Regulatory Class:	Class II
Common Name:	Level 2 Medical Grade Mask
Device Panel:	General Hospital
Product Code:	FXX

lll. PREDICATE DEVICE

Manufacturer: Qiqihar Hengxin Medical Supplies, Ltd. Trade/Device Name: Single-Use Surgical Mask with Ear Loop (K201691)

No reference devices were used in this submission.

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following characteristics were compared between the subject device and the predicate device in Table 1 below

Feature	Subject Device:3 Ply Medical GradeSingle Use ProceduralDisposable Face Mask(K220637)	Predicate Device:Single-Use SurgicalFace Mask with EarLoop (K201691)	Result
Indications for Use	TheDisposableSurgical Face Masksare intended to beworn to protect boththe patient andhealthcare providerfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intendedfor use in infectioncontrol practices toreduce the potentialexposure to blood andbodily fluids.	The single-usesurgical mask withear loop is intendedto be worn to protectboth the patient andhealthcare personnelfrom the transfer ofmicroorganisms,body fluids, andparticulate material.The Single UseSurgical Mask withear loop is intendedfor use in infectioncontrol practices toreduce the potential	Same

Table 1 – Comparison of Technological Characteristics

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	single use, disposabledevice provided non-sterile.	exposure to bloodand bodily fluids. Thisis a single-use,
		disposable device(s),provided non-sterile.
Materials
Inner Facing Layer	Spun-BondPolypropylene	Spun-BondPolypropylene	SAME
Middle Layer	Melt Blownpolypropylene	Melt Blownpolypropylene	SAME
Outer Facing Layer	Spun-bondpolypropylene	Spun-BondPolypropylene	SAME
Nose Piece	Wire, malleablenosepiece, plastic-coated steel	Wire, malleablealuminum nosepiece	Different
Ear Loop	Polyester andspandex materials	polyester	SAME
Color	Blue Outer Layer	Blue Outer Layer	SAME
Mask Style	Flat pleated, ear loop	Flat pleated, ear loop	SAME
Dimension (Width)Adult	$9.5 cm +/-0.5cm$	$9 cm +/-1cm$	SIMILAR
Dimension (Length)Adult	$17 cm +/-0.5cm$	$18 cm +/- 1 cm$	SIMILAR
Single Use	Yes	Yes	SAME
OTC Use	Yes	Yes	SAME
Sterility	Non-Sterile	Non-Sterile	SAME

VII. PERFORMANCE DATA

Table 2 – Benchtop Performance Testing

Item	Subject Device:3 Ply Medical GradeSingle Use ProceduralDisposable Face Mask(K220637)	Predicate Device:Single-Use SurgicalFace Mask with EarLoop (K201691)	Result
ASTM F2100 Level	II	II	PASS
Fluid resistance(ASTM F1862)	32 out of 32 pass at120 mmHG (16.0 kPa)	31 out of 32 pass at120 mmHg (16.0 kPa)	PASS
ParticulateFiltration (ASTMF2299)	>99.99%	> 99%	PASS
Bacterial Filtration(ASTM F2101)	>99.9%	> 99%	PASS

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DifferentialPressure (Delta-P)(ASTM F2100)	8 Liters per minute(L/min) < 6.0mmH20/cm2	< 5.0 mmH20/cm2	PASS
BiocompatibilityISO 10993	Irritation (ISO 10993-10), Sensitization (ISO10993-10), Cytotoxicity(ISO 10993-5)	Irritation (ISO 10993-10), Sensitization(ISO 10993-10),Cytotoxicity (ISO10993-5)	PASS
Flammability	Class 1	Class 1	PASS

Summary of Non-Clinical Performance Testing

The following standards have been used to evaluate the KDI Med Supply's 3 Ply Medical Table 3: Grade Single Use Procedural Disposable Face Mask

ASTM F2100	Standard Specification for Performance of Materials Used in Medical Face Masks
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)
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	Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
EN 14683	2019 Standard Test Method for Differential Pressure 16 CFR Part 1610 Standard for Flammability
ISO 10993-1	1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5	5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
ISO-10993-10	10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

Table 4: The following performance data has been provided from 3 nonconsecutive lots to demonstrate that the subject device meets the criteria of the standards.

Test Methodology,Standard	Purpose	Acceptance Criteria	Results
ASTM F1862	Resistance toPenetration bysynthetic blood	120 mm Hg	120 mm Hg
ASTM F2299	Particulate filtrationefficiency	>98%	> 99.99%
ASTM F2101	Bacterial Filtration	>98%	>99.99%
16 CFR 1610	Flammability	Class 1	Class 1

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ASTM F2100	Differential Pressure(Delta-P)	< 6.0 mm H20/cm2
< 6.0 mm H20/cm2

VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, and effective, and performs well as or better than the legally marketed predicate device.

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.