Disposable Medical Mask

• K Number: K203174
• Device Name: Disposable Medical Mask
• Manufacturer: Dong Guan Kinyet Metal Products Co., Ltd
• Date Cleared: 2021-08-02 ( 280 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Device Description

Disposable Medical Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Mask is sold non-sterile and is intended to be a single use, disposable device.

Predicate Devices

K201137

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable medical mask, with no mention of AI or ML technologies.

Therapeutic

No
The device is described as a protective covering for the nose and mouth to prevent exposure to microorganisms and body fluids, not to treat a disease or condition.

Diagnostic

No
The device is a protective mask designed to prevent exposure to microorganisms and body fluids, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, multi-layered mask made of materials like polypropylene, with ear loops and a nose piece. This indicates a hardware device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
• Device Description and Intended Use: The description clearly states that this is a "protective nose and mouth covering" and is used to "cover the mouth and nose." Its purpose is to act as a physical barrier to prevent the transmission of microorganisms and body fluids.
• Lack of Diagnostic Function: The device does not analyze any biological samples or provide any diagnostic information about a patient's condition. It is a barrier device.
• Performance Studies: The performance studies listed (Fluid Resistance, Filtration Efficiency, etc.) are related to the physical properties and barrier function of the mask, not to any diagnostic capabilities.

Therefore, based on the provided information, the Disposable Medical Mask is a medical device, but it is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Product codes

FXX

Device Description

Disposable Medical Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Mask is sold non-sterile and is intended to be a single use, disposable device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nose and mouth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare workers and patients involved in medical and surgical procedures

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

Non-clinical data: Per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions, the below testing has been completed on the subject device: The testing provided below was performed using 3 nonconsecutive lots with a total of 96 samples evaluated.

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

Non-clinical tests were conducted including: Fluid Resistance Performance (ASTM F1862), Bacterial Filtration Efficiency (ASTM F2100-19), Differential Pressure (ASTM F2100-19), Particulate Filtration Efficiency (ASTM F2100-19), Flammability (21 CFR 1610), Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), and Sensitization (ISO 10993-10). All samples met the predetermined acceptance criteria for all tests. The testing provided below was performed using 3 nonconsecutive lots with a total of 96 samples evaluated.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Fluid Resistance Performance: Level 3:160 mm Hg
Bacterial Filtration Efficiency: >= 98%
Differential Pressure (Delta P): = 98%
Flammability: Class I, Does not Ignite
Cytotoxicity: Non-cytotoxic
Irritation: Non-irritating
Sensitization: Non-sensitizing

Predicate Device(s)

K201137

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

August 2, 2021

Dong Guan Kinyet Metal Products Co., Ltd % Salon Chen System Engineer IMD Medical & Drug technology service institutions Tianbao office room 225,Sha Tai Road No.209 ShenZhen city, Guangdong province 518117 China

Re: K203174

Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 23, 2021 Received: July 23, 2021

Dear Salon Chen:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203174

Device Name Disposable Medical Mask

Indications for Use (Describe)

Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

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 - K203174

Submitter's Information 1.

• Company Name: Dong Guan Kinyet Metal Products Co., Ltd.

• Establishment Registration Number: 3012119360

• Address: NO.38, Weijian Road, Chashan Town, Dongguan City, Guangdong Province, China

• Phone:[phone]

• Fax: [phone]

• Contact Person(Title): Emily Zhang (General Manager)

• E-mail: [e-mail]

• Device Information 2.

• Trade Name: Disposable Medical Mask

• Common Name: Mask,Surgical

• Classification Name: Surgical Apparel

• Model: KLY-301

• 3. Classification

• Classification Product Code: FXX

• Regulation Number: 21 CFR 878.4040

• Classification: Class II

• Review Panel: General Hospital

4. Predicate Device Information:

• 510(k) Number: K201137 >

• Predicate Device Name: ASEPT® Surgical Face Mask Page 1 of 7

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• Manufacturer: PFM Medical, Inc.

• This predicate has not been subject to a design-related recall

• No reference devices were used in this submission.

5. Application Correspondent

• Company Name: IMD Medical & Drug technology service institutions

• Phone: [phone]

• Fax: [phone]

• Contact Person(Title): Salon Chen (System engineer)

• E-mail: [e-mail]

6. Device Description

Disposable Medical Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Mask is sold non-sterile and is intended to be a single use, disposable device.

7. Indications for Use Statement

Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

8. Technological Characteristic Comparison

Elements of Comparison	Proposed Device	Predicate Device	Comparison
Company Name	Dong Guan Kinyet
Metal Products Co., Ltd.	PFM Medical, Inc.	/

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Device Name	Disposable Medical Mask	ASEPT® Surgical Face Mask	/
Classification Product Code	FXX	FXX	Same
Regulation	21 CFR 878.4040	21 CFR 878.4040	Same
Classification Name	Surgical Apparel	Surgical Apparel	Same
Class	II	II	Same
Prescription or OTC	OTC	OTC	Same
Intended Use & Indications for Use	Disposable Medical Mask
is indicated as a protective
nose and mouth covering
for healthcare workers and
patients involved in
medical and surgical
procedures. The masks
are indicated in any
procedure or situation
where there is a risk of
exposure to
microorganisms and body
fluids.	The ASEPT® Surgical
Face Mask is indicated as
a protective nose and
mouth covering for
healthcare workers and
patients involved in
medical and surgical
procedures. The masks
are indicated in any
procedure or situation
where there is a risk of
exposure to
microorganisms and body
fluids.	Similar
	Materials	Inner and Outer Layers	Spun-bond polypropylene	Spun-bond polypropylene
		Middle Layer	Melt blown polypropylene filter	Melt blown polypropylene filter
		Ear Loops	Polyester	Polyester

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| | Nose Piece | Malleable polyethylene
with aluminum wire | Malleable polyethylene
with aluminum wire | | |
|--|------------------|------------------------------------------------------------|------------------------------------------------------------|-----------------|------|
| | Dimension | 17.5cm length x 9.5cm
height | 17.5cm length x 9.5cm
height | Same | |
| | Mask Style | Pleated | Pleated | Same | |
| | Design Features | Malleable nosepiece, flat
pleated,
elastic ear loops | Malleable nosepiece, flat
pleated,
elastic ear loops | Same | |
| | Sterility | Non-sterile | Non-sterile | Same | |
| | Use | Single Use,Disposable | Single Use,Disposable | Same | |
| | Color | Blue and White | Blue and White | Same | |
| | ASTM F2100 level | Level 3 | Level 2 | Different | |
| | Biocompatibility | Cytotoxicity,ISO
10993-5:2009 | Non-cytotoxic | Non-cytotoxic | |
| | | Irritation,ISO
10993-10:2002 | Non-irritating | Non-irritating | Same |
| | | Sensitization,ISO
10993010:2002 | Non-sensitizing | Non-sensitizing | |

9. Summary of Non-Clinical Test

Non-clinical data:

Per FDA document Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions, the below testing has been completed on the subject device: The testing provided below was performed using 3 nonconsecutive lots with a total of 96 samples evaluated.

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Test Methodology	Purpose	Acceptance Criteria	Results
Fluid Resistance Performance
ASTM F1862:
Standard Test Method for
Resistance of Medical
Face Masks to Penetration
by Synthetic Blood	The purpose was to
evaluate the fluid
resistance
performance.	Level 3:160 mm Hg	All samples met the
predetermined acceptance
criteria.
Bacterial Filtration Efficiency
ASTM F2100-19:
Standard Specification for
Performance of Materials
Used in Medical Face Masks	The purpose was to
evaluate the
bacterial filtration
efficiency
performance.	$\geq$ 98%	All samples met the
predetermined acceptance
criteria.
Differential Pressure
(Delta P)
ASTM F2100-19:
Standard Specification for
Performance of Materials
Used in Medical Face
Masks	The purpose was to
evaluate the
differential pressure
performance.