K Number

Device Name

Surgical Face Mask (Ear loops and Tie-on)

Manufacturer

Wuhan Dymex Healthcare Co., Ltd.

Date Cleared

2021-06-07

(115 days)

Product Code

FXX

Regulation Number

878.4040

Intended Use

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(s), provided non-sterile.

Device Description

The Surgical Face Masks are blue color, single use, flat-folded masks with nose piece and ear loops or tie-on. The blue colorant is polypropylene (PP) master batch. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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. The elastic ear loops are not made with natural rubber latex. The tie-on is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K182515

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 surgical face mask, with no mention of AI or ML.

Therapeutic

No.

Explanation: This device is a surgical face mask intended to protect against transfer of microorganisms and fluids, which falls under infection control and personal protective equipment, not direct therapeutic treatment of a disease or condition.

Diagnostic

The document states that the surgical face masks are intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It does not mention any diagnostic function such as detecting, monitoring, or analyzing health conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical product made of materials like polypropylene and polyethylene, with physical components like ear loops or ties and a nose piece. The performance studies focus on material properties and physical performance (fluid resistance, filtration, flammability), not software validation.

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 barrier function, not a diagnostic one.
Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection.
Performance Studies: The performance studies focus on the physical properties and filtration capabilities of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are relevant to its function as a barrier, not to diagnosing a condition or analyzing a sample.
Lack of Diagnostic Elements: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FXX

Device Description

The Surgical Face Masks are blue color, single use, flat-folded masks with nose piece and ear loops or tie-on. The blue colorant is polypropylene (PP) master batch.

The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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. The elastic ear loops are not made with natural rubber latex.

The tie-on is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

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.

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

Not Found

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

Non-clinical tests were conducted to verify that the proposed device met all design specification for the standards and test methods. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A 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);
EN 14683, Medical Face Masks—Requirements and Test Methods;
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
A ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
A 16 CFR 1610, Standard for the Flammability of clothing textiles;

Key Metrics

Fluid Resistance: 32 out of 32 pass at 160 mmHg (acceptance criteria: 29 out of 32 pass at 160 mmHg for level 3)
Particulate Filtration Efficiency: 99.4% (acceptance criteria: >= 98%)
Bacterial Filtration Efficiency: 99.9% (acceptance criteria: >= 98%)
Differential Pressure: 3.1mmH2O/cm^2 (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

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, 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.

June 7, 2021

Wuhan Dymex Healthcare Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K210433

Trade/Device Name: Surgical Face Mask (Ear loops and Tie-on) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX. Dated: May 8, 2021 Received: May 12, 2021

Dear Ivy Wang:

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

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,

Clarence W. Murray, III, PhD Acting 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

Indications for Use

510(k) Number (if known)

K210433

Device Name Surgical Face Mask Ear loops and Tie-on

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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510(K) Summary

K210433

Date of summary prepared: 2021-06-07 A. Applicant: Wuhan Dymex Healthcare Co., Ltd. Address: Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5, Dongfeng Avenue, Wuhan, Hubei, China Contact person: Niki Wang Title: Sales Manager Tel: +86-27-8462 1898 Fax: +86-27-8464 4151 Email: niki.w@dymexhealthcare.com

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Surgical Face Mask Common Name: SURGICAL MASK Model: Ear Loops and Tie on

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

C. Predicate device: K182515 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.

D. Indications for use of the device:

Device Description: E.

The Surgical Face Masks are blue color, single use, flat-folded masks with nose piece and ear loops or tie-on. The blue colorant is polypropylene (PP) master batch.

The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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. The elastic ear loops are not made with natural rubber latex.

The tie-on is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

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.

F. Technological Characteristics Comparison Table

Provided below is a comparison of the subject device with the predicate device Table 1 General Comparison

Device	Proposed Device	Predicate Device	Result
510K #	K210433	K182515	-
Manufacturer	Wuhan Dymex Healthcare Co., Ltd.	Wuhan Dymex Healthcare Co., Ltd.	-
Model Name	SURGICAL FACE MASK
Ear loops and Tie-on	SURGICAL FACE MASK
Ear loops	Similar
Classification	Class II Device, FXX (21 CFR878.4040)	Class II Device, FXX (21 CFR878.4040)	Same
Intend use	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(s), 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(s), provided non-
sterile.	Same
Design Features	Ear Loops, Tie-on, Flat-pleated, 3
layers	Ear Loops, Flat-pleated, 3 layers	Similar

Materials	Outer layer	Spunbond Polypropylene	Spunbond Polypropylene	Same
	Inner layer	Spunbond Polypropylene	Spunbond Polypropylene	Same
	Filter layer	Melt-blown Polypropylene	Melt-blown Polypropylene	Same
	Nose wire	Malleable polyethylene wire	Malleable polyethylene wire	Same
	Ear loops	Spandex	Spandex	Same
	Tie-on	Spunbond Polypropylene	NA	Same
	Color	Blue	Yellow	Different
Dimension
(Length)		17.5cm±0.2cm	17.5cm±0.2cm	Same
		Dimension
(Width)		9.5cm±0.2cm
OTC use				Yes
Sterility		Non-Sterile	Non-Sterile	Same
Use		Single Use, Disposable	Single Use, Disposable	Same
ASTM F2100
Level		Level 3	Level 2	Same

G. Non-Clinical Test Conclusion

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A 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);
EN 14683, Medical Face Masks—Requirements and Test Methods;
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
A ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
A 16 CFR 1610, Standard for the Flammability of clothing textiles;

| Test Methodology | Purpose | Acceptance Criteria:
ASTM F2100 Level 3 | Result |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------|
| Fluid Resistance | The purpose of the
performance testing is to
demonstrate the
functionality of the
subject device. | 29 out of 32 pass at 160 mmHg for level 3 | 32 out of 32 pass at 160 mmHg |
| Particulate
Filtration
Efficiency | | $\geq 98%$ | 99.4% |

| Bacterial Filtration

Efficiency		≥ 98%	99.9%
Differential
Pressure