K Number

Device Name

Surgical Face Mask

Manufacturer

Wuhan Raytex Protection CO., LTD

Date Cleared

2022-01-20

(454 days)

Product Code

FXX

Regulation Number

878.4040

Intended Use

When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.

Device Description

The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.

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

K202061

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance testing focus solely on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.

Therapeutic

No.

The device, a surgical face mask, is intended to prevent the transfer of microorganisms, body fluids, and particulate material, acting as a barrier rather than treating or preventing a disease or condition in a therapeutic manner.

Diagnostic

The device description indicates that surgical face masks are intended to protect against the transfer of microorganisms, body fluids, and particulate material; it does not mention any function for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical surgical face mask made of polypropylene layers with ear loops and a nose piece. The performance studies are related to material properties and physical performance, not software functionality.

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 patients and healthcare workers 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 of a surgical face mask, which is a physical barrier.
Performance Studies and Key Metrics: The performance studies and metrics focus on the physical and filtration properties of the mask (filtration efficiency, fluid resistance, breathability, flammability, biocompatibility). These are relevant to a barrier device, not a diagnostic test.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This surgical face mask does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FXX

Device Description

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

Adults

Intended User / Care Setting

patient and healthcare workers

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: Lab bench testing for safety and performance
Sample Size: Three lots of product were tested. Specific sample sizes for each test are:
- Synthetic Blood Penetration Resistance: 32 samples per lot for 3 lots
- Particulate Filtration Efficiency: Average of samples for 3 lots
- Bacterial Filtration Efficiency: Average of samples for 3 lots
- Flammability: Samples for 3 lots
- Differential Pressure: Average of samples for 3 lots
Key Results:
- Synthetic Blood Penetration Resistance (ASTM F1862): Lot 1: 32 Out of 32 pass at 80 mmHg; Lot 2: 32 Out of 32 pass at 80 mmHg; Lot 3: 32 Out of 32 pass at 80 mmHg. All lots passed the acceptance criteria.
- Particulate Filtration Efficiency (ASTM F2299): Lot 1: Average 96.6 %; Lot 2: Average 96.1 %; Lot 3: Average 96.2%. All results were ≥ 95%.
- Bacterial Filtration Efficiency (ASTM F2101): Lot 1: Average 99.5%; Lot 2: Average 99.4%; Lot 3: Average 99.4%. All results were ≥ 95%.
- Flammability (16 CFR 1610): Lot 1: Class 1; Lot 2: Class 1; Lot 3: Class 1. All results were Class 1.
- Differential Pressure (EN 14683:2019+AC): Lot 1: Average 3.9 mmH2O/cm²; Lot 2: Average 3.8 mmH2O/cm²; Lot 3: Average 4.0 mmH2O/cm². All results were

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.

January 20, 2022

Wuhan Raytex Protection CO., LTD Maggie Yao General Manager RM1201,Mingchuang Building,Greenland,Heping Avenue, Wuchang District Wuhan, Hubei 430060 China

Re: K203161

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 25, 2021 Received: December 16, 2021

Dear Maggie Yao:

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 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) K203161

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

Summary Prepared Date

19 January 2022

Submitter Information 1.

Sponsor Name: WUHAN RAYTEX PROTECTION CO., LTD

Address: RM1201,Mingchuang Building,Greenland,Heping Avenue,Wuchang District,Wuhan,Hubei

Province,430060,China.

Contact Person:Maggie Yao (General Manager)

Phone: +86-27 87263395

Fax: +86-27 88398709

E-mail:sales@vicogard.com

2. Subject Device Information

Type of 510(k):	Traditional
Common Name:	Surgical face mask
Trade Name:	Surgical face mask
510(k) number:	K203161
Classification Name:	Mask,Surgical
Review Panel:	General Hospital
Product Code:	FXX
Regulation Number:	21 CFR 878.4040
Regulation Class:	Class II

3. Predicate Device Information

Sponsor:	Jiangsu Province Jianerkang Medical Dressing Co., Ltd
Common Name:	Medical Face Mask
Trade Name:	Medical Face Mask
510(k) number:	K202061
Review Panel:	General Hospital
Product Code:	FXX
Regulation Number:	21 CFR 878.4040

Regulation Class: Class II

4. Device Description

5. Intended Use

When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.

6. Summary of Comparison and Technological Characteristics

| Elements of

Comparison	Subject Device	Predicate Device	Verdict
Product Name	Surgical face mask	Medical face mask	--
510(k) number	K203161	K202061	--
General Comparison
Intended Use	When properly worn, the
surgical face masks are
intended to protect both
patient and healthcare
workers from transfer of
microorganisms, body fluids
and particulate material.
This
device is non-sterile and for
single use only.	The medical face mask is
intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
materials in infection control
practices to reduce the
potential exposure to blood
and body fluids. It is for single-use
and provided non-sterile.	Same
Model	Flat type	Flat Pleated	Same
Design features	Ear loop	Ear loop	Same
Layers	3	3	Same
Elements of
Comparison	Subject Device	Predicate Device	Verdict
Target population	Adults	Adults	Same
Material	Outer facing layer	polypropylene	polypropylene	Same
	Middle layer	Melt blown polypropylene filter	Melt blown polypropylene	Same
	Inner facing layer	polypropylene	polypropylene	Same
	Nose piece	Single Galvanize Wire, Coated by PE	Polypropylene coated steel wire	Note 1
	Ear loops	Spandex and nylon	Spandex and nylon	Same
Color	Blue	Blue	Same
Dimension (Width)	9.5cm ± 0.5cm	9.5cm	Same
Dimension (Length)	17.5cm ± 0.5cm	17.5cm	Same
Sterility	Non-Sterile	Non-Sterile	Same
Use	Single Use	Single Use	Same
ASTM F2100 Level	Level 1	Level 1	Same
Synthetic Blood
Penetration
Resistance
ASTM F 1862	Lot 1: 32 Out of 32 pass at80 mmHg
Lot 2: 32 Out of 32 pass at 80 mmHg
Lot 3: 32 Out of 32 pass at80 mmHg	80 mmHg	Same
Particulate Filtration
Efficiency
ASTM F 2299	Lot 1:Average 96.6%
Lot 2:Average 96.1 %
Lot 3:Average 96.2%	Average 96.09%	Same
Bacterial Filtration
Efficiency
ASTM F2101	Lot 1: Average 99.5%
Lot 2: Average 99.4%
Lot 3: Average 99.4%	Average 99.8%	Same
Differential Pressure
(Delta P)
EN 14683:2019+AC:	Lot 1: Average 3.9 mmH2 0/cm²
Lot 2: Average 3.8 mmH2	Average 3.9 mmH2 0/cm²	Same
Elements of
Comparison	Subject Device	Predicate Device	Verdict
2019	0/cm²
Lot 3: Average 4.0 mmH2
0/cm²
Flammability
16CFR 1610	Lot 1: Class 1
Lot 2: Class 1
Lot 3: Class 1	Class 1	Same
Cytotoxicity	Comply with ISO 10993-5
Non cytotoxic	Comply with ISO 10993-5
Non cytotoxic	Same
Irritation	Comply with ISO 10993-10
Non irritating	Comply with ISO 10993- 10
Non irritating	Same
Sensitization	Comply with ISO 10993-10
Non sensitizing	Comply with ISO 10993- 10
Non sensitizing	Same

Table 1 - General Comparison

WUHAN RAYTEX PROTECTION CO., LTD Sponsor:

Subject Device: File No.:

Surgical face mask,model:Flat type 510(k) submission report,

510(k) Submission number: K203161

WUHAN RAYTEX PROTECTION CO., LTD Sponsor:

Subject Device: Surgical face mask,model:Flat type

File No.: 510(k) submission report,

510(k) Submission number: K203161

Note 1: The nose piece material of the subject device is Single Galvanize Wire, Coated by PE. The predicate device uses polypropylene coated steel wire. The nose piece does not directly contact the user ' s skin. Biocompatibility testing was conducted on the final device. Performance testing was conducted according to ASTM F2100-19.

Otherwise, all of the specifications and materials of the subject device, Surgical face mask, are the same as the predicate device K202061.

Table 2 - Performance Testing

We have tested three lots of product. The data below is one of these performance tests.

Surgical face mask has been evaluated the safety and performance by lab bench testing according to the following standards:

ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by ynthetic blood (Horizontal projection of fixed volume at a known velocity)
ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.

16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
Determine breathing resistance or differential pressure as directed in EN 14683:2019,AnnexC

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

Item	Test Method	Acceptance Criteria	Result
Fluid
Resistance
Performance
(mmHg)	ASTM F1862	(A) There are no burn
times; or(B) There is only
one burn time and it is
equal to or greater than 3.5
seconds; or(C) The average
burn time of
two or more specimens is
equal to or greater than 3.5
seconds.	Lot 1: 32 Out of 32 pass
at 80 mmHg
Lot 2: 32 Out of 32 pass
at 80 mmHg
Lot 3: 32 Out of 32 pass
at 80 mmHg
Particulate
Filtration
Efficiency
Performance (%)	ASTM F2299	≥ 95%	Lot 1:Average 96.6 % Lot
2:Average 96.1% Lot 3:Average
96.2%
Bacterial Filtration
Efficiency
Performance (%)	ASTM F2101	≥ 95%	Lot 1: Average 99.5%
Lot 2: Average 99.4%
Lot 3: Average 99.4%
Flammability
class	16 CFR 1610	Class 1	Lot 1: Class 1
Lot 2: Class 1
Lot 3: Class 1
Differential
Pressure
(Delta-P)
(mm H2O/cm2)	ASTM F2100-19
EN
14683 :2019+A
C (2019)(E),
Annex C