The AOK 95A Medical Mask (20200049) is 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.

Device Description

The AOK 95A Medical Mask (20200049) is single use, four-layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. 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 AOK 95A Medical Mask will be provided in white and blue. The AOK 95A Medical Mask is sold non-sterile and are intended to be single use, disposable devices.

AI/ML Overview

This document describes the safety and effectiveness of the AOK 95A Medical Mask (K220876) by comparing it to a legally marketed predicate device (AOK Tooling Limited - K211956). The evaluation relies on non-clinical performance testing.

1. Acceptance Criteria and Reported Device Performance

The table below summarizes the acceptance criteria and the reported performance of the AOK 95A Medical Mask. These criteria are based on ASTM 2100 Level 2 standards.

Acceptance Criteria (ASTM 2100 Level 2)	Reported Device Performance (AOK 95A Medical Mask)
Fluid resistance: Pass at 120mmHg	Pass at 120mmHg
Particulate efficiency level: ≥98%	≥98%
Bacterial filtration level: ≥98%	≥98%
Differential pressure: <6.0 mm H2O/cm²	<6.0 mm H2O/cm²
Flammability: Class I	Class I
Biocompatibility: Cytotoxicity, Sensitization, Irritation (Pass)	Cytotoxicity, Sensitization, Irritation (Pass)

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

The document does not specify the exact sample sizes used for each individual test (Fluid Resistance, Flammability, PFE, BFE, Differential Pressure, Biocompatibility). However, the tests are stated as "Bench testing" and "Biocompatibility," implying laboratory-based testing on device samples. The data provenance is implied to be from AOK Tooling Limited, the manufacturer, through their conducted tests. The tests are considered prospective as they are conducted specifically for this submission.

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

This type of medical device (surgical/medical mask) does not typically involve human expert interpretation for establishing ground truth in performance testing. The ground truth for the performance criteria (e.g., filtration efficiency, fluid resistance) is objectively measured through established ASTM testing standards and equipment. Therefore, no human experts were used to establish ground truth for the test set in the traditional sense of clinical image interpretation or diagnosis.

4. Adjudication Method for the Test Set

As mentioned above, the performance tests involve objective, standardized measurements rather than subjective human interpretation. Therefore, no adjudication method (like 2+1, 3+1) was applicable or used for the test results.

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 device is a medical mask and does not involve AI or human reader interpretation. Therefore, no MRMC comparative effectiveness study was conducted or is applicable.

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

This device is a physical medical mask, not an algorithm or AI-powered system. Therefore, no standalone algorithm performance study was conducted or is applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance of the AOK 95A Medical Mask is established through objective measurements against recognized industry standards (ASTM 2100 Level 2). These standards define quantifiable thresholds for parameters like filtration efficiency, fluid resistance, and breathability. Biocompatibility is assessed against established biological safety guidelines for medical devices.

8. The Sample Size for the Training Set

This device is a physical product and does not involve machine learning algorithms that require a "training set." Therefore, no training set sample size is applicable or provided.

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

Since there is no training set for this type of device, this question is not applicable.

Summary

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July 27, 2022

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

Re: K220876

Trade/Device Name: AOK 95A Medical Mask (20200049) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 20, 2022 Received: July 22, 2022

Dear 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 (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 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

Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Number (if known)

K220876

Device Name

AOK 95A Medical Mask (20200049)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Date Prepared:

20-Jul-2022

AOK Tooling Limited Flat 2009, 20/F, Kowloon Plaza, No.485 Castle Peak Road, Cheung Sha Wan, Kowloon Hong Kong, China

Official Contact:	Jerry Teng1-626-203-3809
Proprietary or Trade Name:Common/Usual Name:Classification Name:	AOK 95A Medical Mask (20200049)Mask, SurgicalProduct Code - FXX - Mask, Surgical
Predicate Device:Common/Usual Name:Classification Name:	AOK Tooling Limited - K211956Mask, SurgicalProduct Code - FXX - Mask, Surgical
Device Description:	The AOK 95A Medical Mask (20200049) is single use,four-layer folded masks with ear loops, or straps to tiebehind the user's head, and a nose piece. The ear loopsare held in place over the users' mouth and nose by twoelastic ear loops welded to the facemask. The elastic earloops are not made with natural rubber latex. The nosepiece in the layers of facemask is to allow the user to fitthe facemask around their nose, which is made ofmalleable polyethylene wire. The AOK 95A MedicalMask will be provided in white and blue. The AOK 95AMedical Mask is sold non-sterile and are intended to besingle use, disposable devices.
Principle of Operation:	The mask covers the user's nose and mouth and providesa physical barrier to fluids and particulate materials.
Indications for Use:	The AOK 95A Medical Mask (20200049) is intended tobe worn to protect both the patient and healthcarepersonnel from transfer of microorganisms, body fluidsand particulate material. These face masks are intendedfor use in infection control practices to reduce thepotential exposure to blood and body fluids. This is asingle use, disposable device(s), provided non-sterile.

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Description	Subject Device	Predicate Device	Differences
Manufacturer	AOK Tooling Ltd.	AOK Tooling Ltd.
510(k) Number	TBD	K211956
Model Name	AOK 95A Medical Mask (20200049)	039 Surgical Face Mask
Classification	Class II DeviceFXX21 CFR 878.4040	Class II DeviceFXX21 CFR 878.4040	Identical
Intended use	The AOK 95A Medical Mask (20200049) is intendedto be worn to protect both the patient and healthcarepersonnel from transfer of microorganisms, body fluidsand particulate material. These face masks are intendedfor use in infection control practices to reduce thepotential exposure to blood and body fluids. This is asingle use, disposable device(s), provided non-sterile.	The 039 Surgical Face is intended to be worn toprotect both the patient and healthcare personnelfrom transfer of microorganisms, body fluids andparticulate material. These face masks are intendedfor use in infection control practices to reduce thepotential exposure to blood and body fluids. Thisis a single use, disposable device(s), provided non-sterile.	Identical
Mask Style	Flat pleated	Folded	The mask style isdifferent, butperformance is similar tothe predicate
Materials
Cover Fabric(s)	Non-woven polypropylene; Melt blown non-wovenpolypropylene filter	Non-woven polypropylene; Melt blown non-woven polypropylene filter	Identical
Outer Cover Fabrics	50g Non-woven Fabric	50g Non-woven Fabric	Identical
Middle Layer-1	20g Melt blown Non-woven	20g Melt blown Non-woven	Identical
Middle Layer-2	70g PET Non-woven Fabric	70g PET Non-woven Fabric	Identical
Inner Facing	30g Non-woven Fabric	30g Non-woven Fabric	Identical
Nose Piece	Plastic	Silicone	The difference does notimpact deviceperformance
Ear Loops / Tie-on	Spandex	Spandex	Identical
Color	Blue and White	Blue and White	Similar
Design	Ear loop and tie-on	Ear loop and tie-on	Identical
Dimension (Width /Length)	Small - 165mm × 70mmMedium - 190mm × 80mmLarge - 210mm × 86mm	Small - 208x111 mmMedium — 226x124 mmLarge - 250x138 mmXL - 262x144 mm	The size difference andlack of a small size maskdoes not impact deviceperformance or safety

OTC Use	Yes	Yes	Identical
Use	Single Use, Disposable	Single Use, Disposable	Identical
ASTM 2100 Level	Level 2	Level 2	Identical
Fluid resistance	Pass at 120mmHg	Pass at 120mmHg	Identical
Particulate efficiency level	≥98%	≥98%	Identical
Bacterial filtration level	≥98%	≥98%	Identical
Differential pressure	<6.0 mm H2O/cm2	<6.0 mm H2O/cm2	Identical
Flammability	Class I	Class I	Identical
Biocompatibility	CytotoxicitySensitizationIrritation	CytotoxicitySensitizationIrritation	Identical
Sterility	Non-sterile	Non-sterile	Identical

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Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate. Discussion – Each device is indicated to cover a user's nose and mouth and provides a physical barrier to fluids and particulate materials.

Technology and construction -

The design, fabrication, shape, size, etc. are equivalent to the predicate - AOK Tooling Ltd. - 039 Surgical Face Mask - K211956.

Discussion - This mask is a flat pleated style and covers a smaller surface area of the user's face. However, the difference in mask style of pleated vs. folded does not impact the substantial equivalence of the subject device to the predicate. There is no specific language within FDA product code FXX or its guidance document on the technological characteristics for a surgical mask that would relate to and/or limit the design to a flat pleated style (subject device) vs. vertical folded style. Thus, the difference in design of a pleated vs. folded mask does not impact the substantial equivalence of the subject device to the predicate. Our performance testing demonstrated that the subject device has similar performance to the predicate.

Environment of Use -

The environments of use are identical to predicate - AOK Tooling Ltd. -039 Surgical Face Mask -K211956.

Discussion - The environments of use are the same.

Patient Population -

The patient population of the proposed device and predicate - AOK Tooling Ltd. - 039 Surgical Face Mask - K211956.

Discussion - The identified patient population is equivalent to the predicate.

Non-Clinical Testing Summary -

Bench testing -

We performed the following tests: Fluid Resistance, Flammability, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure. Discussion - The results were similar.

Biocompatibility -

Both devices are considered Surface Contact, Intact Skin, Limited Duration of Use. Discussion - The proposed device materials were found to meet the applicable requirements for biocompatibility safety for the intended population.

Discussion of Differences –

There are no significant differences between the subject and predicate device, both of which are made by the same manufacturer for AOK Tooling. The main differences are the mask style (flatpleated vs. folded) and the size of the mask. Testing demonstrated that we are equivalent to the predicate device despite a difference in mask size and style.

Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the subject device and predicate have been found to be substantially equivalent.

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.