The Plain Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is 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 Plain Surgical Face Mask is a single use, three-layer, flat-folded masks with ear loops and adjustable clips and nose piece. The Plain Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask and with adjustable clips. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

The provided text describes the acceptance criteria and the results of a study conducted for the AOK Tooling Limited's "Plain Surgical Face Mask" (K201517) to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

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

Description	Acceptance Criteria	Reported Device Performance
Fluid Resistance (ASTM F1862)	29 out of 32 pass at 120 mmHg	29 out of 32 pass at 120 mmHg
Flammability Class (16 CFR Part 1610)	Meets Class I, No flame spread on 5 of 5	Class I Non-Flammable (Meets Class I, No flame spread on 5 of 5)
Particulate Filtration Efficiency (ASTM F2299)	≥ 98% Efficiency	Average 99.79% Efficiency
Bacterial Filtration Efficiency (ASTM F2101)	≥ 98% Efficiency	>99% Efficiency
Differential Pressure (Delta P) (ASTM F2100-9 & EN 14683:2019)	< 5.0 $mmH_2O/cm^2$	Average 3.2 $mmH_2O/cm^2$ (Range 3.1-3.4)
Cytotoxicity (ISO 10993-5)	Meets ISO 10993-5 requirements	Pass (Meets ISO 10993-5 requirements)
Irritation (ISO 10993-10)	Meets ISO 10993-10 requirements	Pass (Meets ISO 10993-10 requirements)
Sensitization (ISO 10993-10)	Meets ISO 10993-10 requirements	Pass (Meets ISO 10993-10 requirements)

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

Fluid Resistance (ASTM F1862): 32 samples (29 out of 32 passed).
Flammability: 5 samples (5 of 5 showed no flame spread).
Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure) and Biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The exact sample size for these specific tests is not explicitly stated beyond stating "All the testing samples met the performance acceptance criteria" and "the device meets [ISO] requirements."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be a prospective evaluation of the manufactured device.

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

Not Applicable: This document describes performance testing of a physical device (surgical face mask) against established industry standards (e.g., ASTM, ISO, CFR). The "ground truth" is determined by the objective results of these standardized tests, not by human expert interpretation.

4. Adjudication method for the test set:

Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret data. For the objective performance testing described, the results are derived directly from laboratory measurements against specified criteria.

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 document pertains to the performance evaluation of a surgical face mask, not an AI-powered diagnostic device or an assistive technology for human readers.

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

Not Applicable: This document pertains to the performance evaluation of a physical medical device, not a standalone algorithm.

7. The type of ground truth used:

Objective Test Standards and Biocompatibility Assessments: The ground truth is defined by the objective pass/fail criteria outlined in recognized international and national standards such as ASTM F1862, 16 CFR Part 1610, ASTM F2299, ASTM F2101, ASTM F2100-9, EN 14683:2019, ISO 10993-5, and ISO 10993-10. These standards describe specific laboratory tests and their corresponding acceptance limits.

8. The sample size for the training set:

Not Applicable: This document describes the testing of a manufactured medical device, not the development of an artificial intelligence model that requires a training set.

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

Not Applicable: As there is no training set for an AI model, this question is not relevant to the provided document.

Summary

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September 4, 2020

AOK Tooling Limited % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K201517

Trade/Device Name: Plain Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 4, 2020 Received: June 8, 2020

Dear Mr. Paul Dryden:

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 (OS) 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.

CAPT Elizabeth Claverie, MS 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

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Indications for Use

510(k) Number (if known) K201517

Device Name Plain Surgical 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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Date Prepared:

02-Sep-2020

Sponsor:	AOK Tooling Limited#8, Longtian 3Rd, Longtian Street, Pingshan Dist.Shenzhen, China 518122Tel: +852-0-23101703
Sponsor Contact:	Francis NithyananthanProject Director
Proprietary or Trade Name:	Plain Surgical Face Mask
Common Name:	Mask, Surgical
Classification Name:	Surgical apparel
Classification:	Class II
Product Code:	FXX
Regulation Number:	21 CFR 878.4040
Predicate Devices:	Wuhan Dymex Healthcare Co., Ltd. - Surgical Face Mask - K18251

Device Description:

Indications for Use:

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Table 1: Comparison to Predicate
Description	Predicate Device	Proposed Device	Comparison
Manufacturer	Wuhan Dymex Healthcare Co Ltd	AOK Tooling Ltd.
510(k) Number	K182515	K201517
Device Name	Surgical Face Mask	Plain Surgical Face Mask
Classification	Class II DeviceFXX21 CFR878.4040	Class II DeviceFXX21 CFR878.4040	Same
Intended use	The Surgical Face Mask is intended tobe worn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids andparticulate material. The face mask isintended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids.This is a single use, disposable device,provided non-sterile.	The Plain Surgical Face Mask isintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, body fluidsand particulate material. The face mask isintended for use in infection controlpractices to reduce the potential exposureto blood and body fluids. This is a singleuse, disposable device, provided non-sterile.	Same
Model	Ear Loops, Flat Pleated3 layers	Ear Loops with adjustable clips, FlatPleated, 3 layers	Similar
Materials
Outer Cover Fabrics	Spun-bond polypropylene	Spun-bond polypropylene	Same
Middle Layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
Inner Facing	Spun-bond polypropylene	Spun-bond polypropylene	Same
Nose Piece	Malleable polyethylene wire	Malleable polyethylene wire	Same
Ear Loops/Adjustable Clips	Spandex ear loops	Spandex ear loops and polypropylene clips	Similar
Color	Yellow	White	Different
Dimension (Length)	17.5cm ± 0.2cm	17.5cm ±0.2cm	Same
Dimension (Width)	9.5cm ± 0.2cm	9.5cm ± 0.2cm	Same
OTC Use	Yes	Yes	Same
Sterile	Non-sterile	Non-sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
ASTM 2100 Level	Level 2	Level 2	Same

Summary of Technological Characteristics:

Table 2: Performance Testing

March 5, 2004.

Non-Clinical Testing Summary:

Description	Subject Device	Acceptance Criteria
Fluid Resistance (ASTM F1862)	29 out of 32 pass at 120 mmHg	29 out of 32 pass at 120 mmHg
Flammability class16 CFR Part 1610	Class I Non-Flammable	Meets Class I, No flame spread on 5 of 5
Particulate Filtration EfficiencyASTM F2299	Average 99.79% Efficiency	≥ 98% Efficiency
Bacterial Filtration EfficiencyASTM F2101	>99% Efficiency	≥ 98% Efficiency
Differential Pressure (Delta P)ASTM F2100-9 andEN 14683:2019	Average 3.2 $mmH_2O/cm^2$ (Range 3.1-3.4)	< 5.0 $mmH_2O/cm^2$

The proposed 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

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All the testing samples met the performance acceptance criteria.

Item	Proposed device	Result
Cytotoxicity	Under the conditions of the study, the device meets ISO 10993-5 requirements.	Pass
Irritation	Under the conditions of the study, the device meets ISO 10993-10 requirements.	Pass
Sensitization	Under the conditions of the study, the device meets ISO 10993-10 requirements.	Pass

	Table 3: Biocompatibility Testing

Conclusion:

The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate K182515,Wuhan Dymex Healthcare Surgical Face Mask.

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.