Surgical Face Mask

• K Number: K202903
• Device Name: Surgical Face Mask
• Manufacturer: Rizhao Sanqi Medical & Health Articles Co., Ltd.
• Date Cleared: 2022-03-24 ( 541 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, 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 Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

Predicate Devices

K160269

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.
This device is described as a "Surgical Face Mask" intended for protection from transfer of microorganisms and body fluids, not for treating any specific medical condition or disease.

Diagnostic

No
The device, a surgical face mask, is intended to protect against the transfer of microorganisms and body fluids, and is used in infection control. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical surgical face mask made of nonwoven polypropylene materials with ear loops or ties and a nose clip. The performance studies focus on physical properties and biological compatibility, 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 mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
• Device Description: The description details the physical construction of the mask, which is consistent with a barrier device.
• Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are not diagnostic performance metrics.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not perform any of these functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, 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.

Level 1 Surgical Face Mask models: SQ-1001
Level 2 Surgical Face Mask models: SQ-2001, SQ-2001H, SQ-2004, SQ-2004H
Level 3 Surgical Face Mask models: SQ-3001, SQ-3001H

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, yellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided 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

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 (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 to the predicate device. 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:

• ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In VitroCytotoxicity
• ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
• 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;
• ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
• 16 CFR 1610, Standard for the Flammability of clothing textiles;

For Level 1: SQ-1001

• Fluid Resistance Performance ASTM F1862:
  • Acceptance Criteria: 29 out of 32 pass at 80 mmHg
  • Result: 3 nonconsecutive lots tested, PASS
• Particulate Filtration Efficiency ASTM F2299:
  • Acceptance Criteria: >= 95%
  • Result: PASS
• Bacterial Filtration Efficiency ASTM F2101:
  • Acceptance Criteria: >= 95%
  • Result: PASS
• Differential Pressure (Delta P) EN 14683 Annex C:
  • Acceptance Criteria: = 98%
  • Result: PASS
• Bacterial Filtration Efficiency ASTM F2101:
  • Acceptance Criteria: >= 98%
  • Result: PASS
• Differential Pressure (Delta P) EN 14683 Annex C:
  • Acceptance Criteria: = 98%
  • Result: PASS
• Bacterial Filtration Efficiency ASTM F2101:
  • Acceptance Criteria: >= 98%
  • Result: PASS
• Differential Pressure (Delta P) EN 14683 Annex C:
  • Acceptance Criteria: = 98%
  • Result: PASS
• Bacterial Filtration Efficiency ASTM F2101:
  • Acceptance Criteria: >= 98%
  • Result: PASS
• Differential Pressure (Delta P) EN 14683 Annex C:
  • 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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March 24, 2022

Rizhao Sanqi Medical & Health Articles Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai, Shanghai 200122 China

Re: K202903

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 24, 2021 Received: December 29, 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

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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 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 ([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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202903

Device Name Surgical Face Mask

Indications for Use (Describe)

The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, 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.

Level 1 Surgical Face Mask models: SQ-1001 Level 2 Surgical Face Mask models: SQ-2001, SQ-2001H, SQ-2004, SQ-2004H Level 3 Surgical Face Mask models: SQ-3001, SQ-3001H

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

K202903

Date of Summary prepared: 2021-12-24

A. Applicant:

Rizhao Sanqi Medical & Health Articles Co., Ltd. Address: Heshan Industry park, Donggang District, Rizhao, Shandong Province, China Contact person: Julia Yu Title: Sales Manager Tel: [phone] Fax: [phone] Email: [e-mail]

Submission Correspondent:

Primary contact: Ms. Ivy Wang

Shanghai SUNGO Management Consulting Co., Ltd.

Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

Secondary contact: Mr. Raymond Luo

Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

B. Device:

Trade Name: SURGICAL FACE MASK Common Name: SURGICAL MASK Model:

Table 1 – Surgical face mask model numbers

Mask Style	Ear loops	Tie-on	Color
Level 1	SQ-1001	-
Level 2	SQ-2001	SQ-2001H	Blue, white, pink,
Level 2 with visor	SQ-2004	SQ-2004H	green, yellow
Level 3	SQ-3001	SQ-3001H

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

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C. Predicate device:
K160269	Surgical Face Masks (Ear loops and Tie-on)	SAN-M PACKAGE CO., LTD.

D. Indications for use of the device:

The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, 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.

E. Device Description:

The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

F. Technological Comparison with predicate device

Device	Subject Device	Predicate Device	Result
510K #	K202903	K160269
Manufacturer	Rizhao Sanqi Medical & Health Articles
Co., Ltd.	SAN-M PACKAGE CO., LTD.
Model Name	SURGICAL FACE MASK	Surgical Face Masks (Ear loops
and Tie-on)	Similar
Classification	Class II Device, FXX (21 CFR878.4040)	Class II Device, FXX (21 CFR878.4040)	Same
Intend use	The Surgical Face Mask is intended to
be worn to protect both the patient
and healthcare personnel from
transfer of microorganisms, body
fluids, and particulate material.
When worn properly, 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. 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,
provided non-sterile.	Same
Materials	Level 1	Level 1	-
	Level 2	Level 2
	Level 3	Level 3
Outer layer	Spunbond Polypropylene	Polypropylene	Same
Inner layer	Spunbond Polypropylene	Polypropylene	Same
Filter layer	Melt-blown	1. Polypropylene spunbond	Similar
	1.Melt-blown
	Polypropylene	Polypropylene
2.Microporous Film	2. Polypropylene meltblown
Nose wire		Steel coated by polypropylene	Polyethylene coated steel wire	Different
Ear loops		Spandex	Polyester, polyurethane	Different
Tie-on	Spunbond Polypropylene		Polypropylene spunbond or
polyester spunbond	Similar
Design Features	Ear Loops, Tie-on		Ear Loops, Tie-on	Same
Offer with visor	Yes		Yes	Same
Mask style	3 Flat Pleated	4 Flat Pleated	4 Flat Pleated	Similar
Color	Blue, white, pink, green, yellow		white or blue	Different
Dimension
(Length)	175±5mm		175±5mm	Same
Dimension
(Width)	95±5mm		95±5mm	Same
OTC use	Yes		Yes	Same
Sterility	Non-Sterile		Non-Sterile	Same
Use	Single Use, Disposable		Single Use, Disposable	Same
Biocompatibility	Non-cytotoxic, Non-sensitizing,
non-irritating		Non-cytotoxic, Non-sensitizing,
non-irritating	Same
Performance
Testing (ASTM

2100. | Level 1 | Level 2 Level 3 | Level 1 Level 2 Level 3 | - |
      | Fluid
      Resistance | Meet ASTM F1862-17 | | Meet ASTM F1862-13 | similar |
      | Particulate
      Filtration
      Efficiency | Meet ASTM F2299-17 | | Meet ASTM F2299-03 | Similar |
      | Bacterial
      Filtration
      Efficiency | Meet ASTM F2101-19 | | Meet ASTM F2101-14 | Similar |
      | Differential
      Pressure | Meet EN 14683: 2019, Annex C | | Meet MIL-M36945C | Different |
      | Flammability | Meet 16 CFR 1610 | | Meet 16 CFR 1610 | Similar |
      | Biocompatibility | Non-cytotoxic, non-sensitizing,
      non-irritating | | Non-cytotoxic, non-sensitizing,
      non-irritating | Same |

Table 2 General Comparison

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Rizhao Sanqi Medical & Health Articles Co., Ltd. Heshan Industry park, Donggang District, Rizhao, Shandong Province, China

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. 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 VitroCytotoxicity

• ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin

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Sensitization

• 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;

• ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;

• 16 CFR 1610, Standard for the Flammability of clothing textiles;

Mask Style	Ear loops	Tie-on	Color
Level 1	SQ-1001	-
Level 2	SQ-2001	SQ-2001H	Blue, white, pink,
Level 2 with visor	SQ-2004	SQ-2004H	green, yellow
Level 3	SQ-3001	SQ-3001H

For level 1: SQ-1001

| Item | Purpose | Acceptance Criteria
Level 1 | Result |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------------|
| Fluid Resistance
Performance ASTM
F1862 | The purpose of the performance testing is to demonstrate the functionality of the subject device. | 29 out of 32 pass at 80 mmHg | 3 nonconsecutive lots tested
PASS |
| Particulate Filtration
Efficiency ASTM F2299 | | $\ge$ 95% | PASS |
| Bacterial Filtration
Efficiency ASTM F2101 | | $\ge$ 95% | PASS |
| Differential Pressure
(Delta P) EN 14683
Annex C | |