K Number

Device Name

Surgical Face Mask

Manufacturer

RFX+CARE Manufactoring Co., Ltd.

Date Cleared

2021-06-02

(218 days)

Product Code

FXX

Regulation Number

878.4040

Intended Use

The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This 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 as sterile.

Device Description

The surgical face mask is provided as sterile, single use, 3 lavers, flat-pleated style with ear loops and nose-piece. The outer layer and inner layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt-blown fabric (polypropylene). Each mask contains ear loops to secure the mask over the user's face and mouth with nose-piece to firmly fit over the nose. This device is not made from any natural rubber latex.

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

Therapeutic

No.
The device description and intended use clearly state its purpose is to protect against microorganisms, body fluids, and particulate materials for infection control, not to treat or cure a disease or condition.

Diagnostic

No
The description of the surgical face mask's intended use and performance tests indicates it is for protection and infection control, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical, multi-layered face mask made of polypropylene materials with ear loops and a nose-piece. The performance studies focus on physical properties and biocompatibility, not software functionality.

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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The description clearly states the surgical face mask is intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate materials. It acts as a physical barrier.
Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient or user.
Performance Metrics: The performance metrics listed (Fluid Resistance, Bacterial Filtration Efficiency, etc.) relate to the physical barrier properties of the mask, not to the analysis of biological samples.

The intended use and function of this surgical face mask are entirely focused on providing a physical barrier for protection, which is not the purpose of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FXX

Device Description

The surgical face mask is provided as sterile, single use, 3 layers, flat-pleated style with ear loops and nose-piece. The outer layer and inner layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt-blown fabric (polypropylene). Each mask contains ear loops to secure the mask over the user's face and mouth with nose-piece to firmly fit over the nose. This device is not made from any natural rubber latex.

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

Non-clinical Test performed on the proposed device.
7.1 Biocompatibility testing:
The biocompatibility evaluation for the surgical face mask was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The outer layer, inner layer and ear loops are considered to be contacted with patient's intact face skin for duration of less than 24 hours. And the biocompatibility evaluation included the following tests:

Cytotoxicity
Skin Sensitization
Skin Irritation
7.2 Physical performance testing:
Physical performance was conducted, and the results show that the proposed device complies with the following standards:
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- Fluid Resistance Performance (mmHg) (ASTM F 1862-17): 32 out of 32 pass at 120 mmHg (Statistics of three lots). Acceptance criteria: 29 out of 32 pass at 120 mmHg. Result: Pass
- Bacterial Filtration Efficiency Performance (%) (ASTM F2101-19): 99.6%-99.8% (Statistics of three lots). Acceptance criteria: >= 98%. Result: Pass
- Differential Pressure (Delta-P) (mm H2O/cm2) (EN 14683: 2019): 4.14-5.90 mmH2O/cm² (Statistics of three lots). Acceptance criteria: = 98%. Result: Pass
- Flammability (16 CFR Part 1610): Class I (Statistics of three lots). Acceptance criteria: Class I. Result: Pass
  7.3 Ethylene oxide Sterilization Validation:
  The proposed device is also provided for sterilization validation is performed and the results show that the proposed device complies with the following standards:
ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
7.4 Clinical Test Conclusion: No clinical study is included in this submission.

Key Metrics

Fluid Resistance Performance (mmHg): 32 out of 32 pass at 120 mmHg
Bacterial Filtration Efficiency Performance (%): 99.6%-99.8%
Particulate Filtration Efficiency Performance (%): 99.69% -99.98%
Differential Pressure (Delta-P): 4.14-5.90 mmH2O/cm²
Flammability: Class I
Biocompatibility: Non-cytotoxic, Non-sensitizing, Non-irritating

Predicate Device(s)

K182515

Reference Device(s)

Not Found

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

Image /page/0/Picture/0 description: The image contains 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 2, 2021

RFX+CARE Manufacturing Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K203190

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 27, 2020 Received: October 27, 2020

Dear James Tsai:

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 and Part 809 ); 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.

Ryan Ortega, 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) K203190

Device Name 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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510(k) Summary

K203190

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Administrative Information

Date of Summary prepared	April 23, 2021
Manufacturer information	Company: RFX+CARE Manufacturing Co., Ltd.
Company address:
No. 7 Lanjiang Road, Yuecheng District, Shaoxing,
Zhejiang, People's Republic of China
Contact person: Zhou Xiufeng
Phone: +86-13575509137
E-mail: xiufeng.zhou@rfx-care.com
Submission Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
Address: 1713A, 17th Floor, Block A, Zhongguan
Times Square, Nanshan District, Shenzhen
Contact person: James Tsai
E-Mail: james.tsai@cefda.com; field@cefda.com

2. Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Surgical face mask
Common name:	Surgical face mask
Classification name:	Surgical Face Mask, Apparel
Review Panel:	General and plastic surgery devices
Product Code:	FXX
Device Class:	II
Regulation Number:	878.4040

3. Predicate Device Information

Sponsor:	Wuhan Dymex Healthcare Co., Ltd.
Trade name:	Surgical face mask
Common name:	Surgical face mask
Classification name:	Surgical Face Mask, Apparel
Review Panel:	General and plastic surgery devices
Product Code:	FXX

ll Device Class: 510(K) Number: K182515 Production regulation: | 21 CFR §878.4040

4. Device Descriptions

5. Indications for Use

| Comparison

item	Proposed Device	Predicate Device	Remark
Manufacturer	RFX+CARE
Manufacturing Co., Ltd.	Wuhan Dymex Healthcare
Co., Ltd.	/
510k number	K203190	K182515	/
Product name	Surgical face mask	Surgical face mask	Same
Product Code	FXX	FXX	Same
Classification	Class II (21 CFR 878.4040)	Class II (21 CFR 878.4040)	Same
Intended
use &
Indications for
Use	The surgical face mask is
intended to be worn to
protect both patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
materials. This 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 as 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

Model and
features	D20108
Ear Loops, Flat Pleated, 3
layers	Ear Loops, Flat Pleated, 3
layers	Same
Outer layer	Spunbond polypropylene	Spunbond polypropylene	Same
Middle layer	Melt-blown fabric
(polypropylene)	Melt blown polypropylene	Same
Inner layer	Spunbond polypropylene	Spunbond polypropylene	Same
Nose piece	Polyethylene	Malleable polyethylene wire	Different
Ear loops	Polyester & polyurethane
filament	Spandex	Different
Color	Blue	Yellow	Different
Dimension	Mask body: 17.5cm*9.5cm
Nose-piece: 8cm-15cm
Ear loop: 16.5cm-18cm	Mask body: 17.5cm*9.5cm	Similar
OTC use	Yes	Yes	Same
Sterility	Sterile	Non-sterile	Different
Sterilization
method and
S.A.L.	Sterilized by ethylene
oxide gas, SAL=10-6	Not applied	Different
Use	Single-use, disposable	Single-use, disposable	Same
ASTM F2100
level	Level 2	Level 2	Same
Fluid
Resistance
Performance	32 out of 32 pass at 120
mmHg
(ASTM F1862)	32 out of 32 pass at 120
mmHg	Same
Particulate
Filtration
Efficiency	Pass at 99.69% -99.98%
(ASTM F2299)	Pass at 99.7%	Similar
Bacterial
Filtration
Efficiency	Pass at 99.6%-99.8%
(ASTM F2101)	Pass at 99.9%	Similar
Differential
Pressure
(Delta-P)	Pass at 4.14-5.90
mmH2O/cm²
(EN 14683)	Pass at 4.0 mmH₂O/cm²	Similar
Flammability
16
CFR 1610	Class I
(16 CFR Part 1610)	Class I	Same
Biocompatibili
ty	Conform with ISO10993-1;
Non-cytotoxic, Non-
sensitizing, Non-irritating	Conform with ISO10993-1;
Non-cytotoxic, Non-
sensitizing, Non-irritating	Same
Item	Proposed device	Result
Cytotoxicity	Under the conditions of the study, the device is non-cytotoxic.	Pass
Skin
Sensitization	Under the conditions of the study, the device is non-sensitizing.	Pass
Skin Irritation	Under the conditions of the study, the device is non-irritating.	Pass

6. Summary of Technological Characteristics

From the comparison table and the gap analysis above, the differences in the materials, colors and sterility status will not raise additional issue for safety and

effectiveness. Physical performance tests and biocompatibility evaluation have been carried out on the finished devices which include all construction materials and color additives; EO sterilization validation has also been provided to prove the product sterility and performance.

7. Non-clinical Test performed on the proposed device

The following performance data of surgical face mask were provided in support of the substantial equivalence determination:

7.1 Biocompatibility testing

The biocompatibility evaluation for the surgical face mask was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The outer layer, inner layer and ear loops are considered to be contacted with patient's intact face skin for duration of less than 24 hours. And the biocompatibility evaluation included the following tests:

· Cytotoxicity
· Skin Sensitization
· Skin Irritation

7.2 Physical performance testing

Physical performance was conducted, and the results show that the proposed device complies with the following standards:

· ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks

Item	Subject device	Acceptance criteria
Fluid Resistance
Performance (mmHg)
(ASTM F 1862-17)	32 out of 32 pass at 120 mmHg
(Statistics of three lots)	29 out of 32 pass at
120 mmHg	Pass
Bacterial Filtration
Efficiency
Performance (%)
(ASTM F2101-19)	99.6%-99.8%
(Statistics of three lots)	≥ 98%	Pass
Differential Pressure	4.14-5.90 mmH2O/cm²