Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard medical face mask. There is no mention of AI or ML in the intended use, device description, or performance evaluation sections.

Therapeutic

No

Explanation: The device is intended for protection from transfer of microorganisms and body fluids, which is a barrier function, not a therapeutic one. It does not treat or cure any condition.

Diagnostic

No
The device is a medical face mask, intended for protection from microorganisms and body fluids, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of materials like polypropylene, nylon, spandex, PE, and galvanized iron wire, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
Device Description: The description details the physical components and materials of the mask, which are designed for filtration and physical protection.
Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical properties and filtration capabilities of the mask (fluid resistance, filtration efficiency, differential pressure, flammability, biocompatibility), not on diagnostic accuracy or analytical performance.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This face mask does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The medical face masks are intended to be worn to protect both the patient and healthcare persomel 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 non-sterile.

Product codes

FXX

Device Description

The Medical Face Masks are single use, flat-pleated, ear loop masks that are provided in blue. The medical face masks are available in three types, which are Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 2 and Level 3 masks are exactly the same. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer is made of meltblown polypropylene filter. The ear loops are made of nylon and spandex. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The nose of PE and galvanized iron wire. Users can adjust the nose clip according to the shape of the nose and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
ASTM F1862/F1862M: 2017 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/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
EN 14683: 2019, Annex C, Medical face masks- Requirements and test methods
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process.

Key results:

Fluid Resistance Performance: Pass at 160 mmHg, Acceptance Criteria: No penetration at 160 mmHg, Conclusion: Meet the requirement
Particulate Filtration Efficiency: Pass at 99.2%, Acceptance Criteria: ≥98%, Conclusion: Meet the requirement
Bacterial Filtration Efficiency: Pass at 99.2%, Acceptance Criteria: ≥98%, Conclusion: Meet the requirement
Differential Pressure (Delta-P): Pass at 3.8 mm H2O/cm2, Acceptance Criteria:

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.

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

January 17, 2022

Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K212994

Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 18, 2021 Received: September 20, 2021

Dear Diana Hong:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212994

Device Name Medical face mask

Indications for Use (Describe)

The medical face masks are intended to be worn to protect both the patient and healthcare persomel 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 non-sterile.

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K212994

Date of Preparation: 12/23/2021 1.
1. Sponsor Identification

Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.

Building B27 Huachuang Animation Industrial Park, Jinshan Village, Shiqi Town, Panyu District, Guangzhou, Guangdong, China

Establishment Registration Number: 3016792608.

Contact Person: Hao Zheng Position: Business Manager Tel: +86-20-39969520 Email: 2281976947@qq.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Medical Face Mask Common Name: Mask

Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Intended Use/Indications for Use:

The medical face masks are intended to be worn to protect 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 non-sterile.

Device Description:

The Medical Face Masks are single use, flat-pleated, ear loop masks that are provided in blue. The medical face masks are available in three types, which are Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 2 and Level 3 masks are exactly the same. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer is made of meltblown polypropylene filter. The ear loops are made of nylon and spandex. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The nose of PE and galvanized iron wire. Users can adjust the nose clip according to the shape of the nose and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile.

Identification of Predicate Device ર.
510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on)

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Summary of Technological characteristics 6.

ITEM	Proposed Device	Predicate Device K160269	Remark
Product Code	FXX	FXX	Same
Regulation No.	21 CFR 878.4040	21 CFR 878.4040	Same
Class	II	II	Same
Indications
for
Use	The medical 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 non-
sterile.	The 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 non-sterile.	Same
Mask style	Flat-pleated	Flat-pleated	Same
ASTM
F2100
Level	Level 1, Level 2, Level 3	Level 1, Level 2, Level 3	Same
Design feature	Ear loop	Ear loop and Tie-on	Different
Color	Blue	Blue, White	Different
Dimension	Mask body: 175mm×95mm
Nose Clip: 100±5mm
Ear loop: 170±5mm	175×90mm
Nose Clip: 100±5mm
Ear loop: 180×90mm	Different
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use, Disposable	Single Use, Disposable	Same
Particulate
filtration
efficiency	Pass at 99.2%	Level 1: Pass at 99.6%
Level 2: Pass at 99.6%
Level 3: Pass at 99.7%	Different
Bacterial
filtration
efficiency	Pass at 99.2%	Level 1: Pass at 98%
Level 2: Pass at 98%
Level 3: Pass at 99%	Different
Differential
pressure	Pass at 3.8 mm H2O/cm²	Level 1: Pass at 2.0 mmH2O/cm²
Level 2: Pass at 1.6 mmH2O/cm²
Level 3: Pass at 2.5 mmH2O/cm²	Different
Flammability	Class 1	Class 1	Same
Fluid resistance	Pass at 160 mmHg	Level 1: Pass at 80 mmHg
Level 2: Pass at 120 mmHg
Level 3: Pass at 160 mmHg	Different
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Patient Contacting Material
Outer facing layer	Spunbond Polypropylene	Polypropylene	Different
Middle layer	Meltblown Polypropylene Filter	1. Polypropylene spunbond

Polypropylene meltblown | |
| Inner facing layer | Spunbond Polypropylene | Polypropylene | |
| Nose clip | PE and Galvanized iron wire | Polyethylene coated steel wire | Same |
| Ear loop | Nylon and Spandex | Polyester, polyurethane | |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the study, the proposed device was non-cytotoxic. | Under the conditions of the study, the subject device was non-cytotoxic. | |
| Sensitization | Under the conditions of the study, the proposed device was non-sensitizing. | Under the conditions of the study, the subject device was non-sensitizing. | |
| Irritation | Under the conditions of the study, the proposed device was non-irritating. | Under the conditions of the study, the subject device was non-irritating. | |

Table 1 Comparison of Medical Face Mask

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Different - Design feature

The proposed masks are ear-loop masks. The design features of the proposed device can be covered by the design features of the predicate device. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different - Color

The proposed device is blue and the predicate device is provided in two colors, the proposed device can be covered by the predicate device. In addition, the biocompatibility test has been conducted and test results did not show any adverse effects. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different - Dimension

The dimension for the proposed device is different from the predicate device. However, the difference does not affect the indication for use and will not raise safety issues. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different - Particulate filtration efficiency

The test result for particulate filtration efficiency for the proposed device is different from the predicate

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device. The proposed devices are available in Level 1, Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 1, Level 3 masks are exactly the same. Therefore, the particulate filtration efficiency test was conducted on Level 3 masks and the test result can meet the requirements based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different - Bacterial filtration efficiency

The test result for bacterial filtration efficiency for the proposed device is different from the predicate device. The proposed devices are available in Level 1, Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 1, Level 2 and Level 3 masks are exactly the same. Therefore, the bacterial filtration efficiency test was conducted on Level 3 masks and the test result can meet the requirements based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different - Differential pressure

The test result for differential pressure for the proposed device is different from the predicate device. The proposed devices are available in Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 1, Level 2 and Level 3 masks are exactly the same. Therefore, the differential pressure test was conducted on Level 3 masks and the test result can meet the requirements of the standard ASTM F2100-19 which was recognized by FDA. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different - Fluid resistance

The test result for fluid resistance for the proposed device is different from the predicate device. The proposed devices are available in Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 1, Level 2 and Level 3 masks are exactly the same. Therefore, the fluid resistance test was conducted on Level 3 masks and the test result can meet the requirements based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of the proposed device.

Different - Patient Contacting Material

The patient contacting material for the proposed device is different from the predicate device. However, biocompatibility test has been conducted on the proposed device and the result does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness of the proposed device.

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7. Summary of Non-Clinical Test

Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
ASTM F1862/F1862M: 2017 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/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
EN 14683: 2019, Annex C, Medical face masks- Requirements and test methods
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process.

| Performance

Characteristics	Test Method	Test result	Acceptance Criteria
Fluid Resistance
Performance	ASTM
F1862/F1862M:
2017	Pass at 160
mmHg	No penetration at 160
mmHg	Meet the requirement
Particulate Filtration
Efficiency	ASTM
F2299/F2299M-03
(2017)	Pass at 99.2%	≥98%	Meet the requirement
Bacterial Filtration
Efficiency	ASTM F2101:
2019	Pass at 99.2%	≥98%	Meet the requirement
Differential Pressure
(Delta-P)	EN 14683: 2019,
Annex C	Pass at 3.8 mm
H2O/cm2