Surgical Mask

K210744 · Chongqing PA Xijia Biotechnology Co., Ltd. · FXX · Dec 14, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210744
• Device Name: Surgical Mask
• Applicant: Chongqing PA Xijia Biotechnology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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, provided non-sterile.

Device Story

Surgical mask; single-use, disposable, non-sterile, flat-pleated, three-layer design. Input: physical barrier against airborne particles and fluids. Operation: mechanical filtration via three-layer structure (spun-bond polypropylene outer/inner layers, melt-blown polypropylene filter). Output: physical protection for wearer and patient. Used in clinical settings or general use; worn over mouth and nose, secured by elastic polyester ear loops and malleable aluminum nose piece. Provides barrier protection to reduce infection risk.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19e1 Level 2 standards, including Bacterial Filtration Efficiency (99.86%), Particulate Filtration Efficiency (98.40%), Differential Pressure (5.3 mmH2O/cm2), Fluid Resistance (120 mmHg), and Flammability (Class 1). Biocompatibility testing confirmed non-cytotoxic, non-irritating, and non-sensitizing properties.

Technological Characteristics

Three-layer flat-pleated mask. Materials: spun-bond polypropylene (outer/inner), melt-blown polypropylene (filter), polyester (ear loops), aluminum (nose piece). ASTM F2100-19e1 Level 2 compliant. Dimensions: M (152x70mm), L (175x90mm), XL (180x100mm). Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material in infection control practices to reduce exposure to blood and body fluids.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Disposable Surgical Face Mask (K153496)

Submission Summary (Full Text)

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December 14, 2021

Chongqing Pa Xijia Biotechnology Co., Ltd. % May Wu Manager of Business Development Sichuan JIULUEHUI Consulting Co., Ltd. Room 1401, Building 4, No. 666, Chenglong Avenue Chengdu, Sichuan 610101 China

Re: K210744

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

Dear May Wu:

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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210744

Device Name Surgical Mask

#### Indications for Use (Describe)

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.

| 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 - K210744

This summary of 510(k) is being submitted in accordance with requirements of the SMDA 21 CFR 807.92.

## 1. Date of Prenaration: February 28, 2021

#### Sponsor Identification 2.

Chongqing Pa Xijia Biotechnology Co., Ltd. No. 27-5, Fengsheng Road, Jiulongpo District,Chongqing,China

Contact Person: Zheng Tao Position: Head of Firm Tel: [phone]

### 3. Designated Submission Correspondent

Miss. May Wu Sichuan JIULUEHUI Consulting Co., Ltd. Room 1401, Building 4, No. 666, Longcheng Avenue, Chengdu City, Sichuan Province, China Tel: [phone] Email: consulting(@sc9lh.cn

#### 4. Device Information

Trade name: Surgical Mask Common name: Surgical Face Mask Model: Ear-loop

## 5. Classification

Production code: FXX Regulation number: 21 CFR 878.4040 Classification: Class II Classification name: Surgical Face Mask Review Panel: Surgical Apparel

#### Indication for Use Statement 6.

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.

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# 7. Device Descrintion

The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece.

The Surgical Masks will be provided in blue. The medical face masks are sold nonsterile and are intended to be single use, disposable devices.

The Surgical 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 made of polyester. 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 aluminum wire.

### 8. Identification of Predicate Device(s)

Manufacturer: Xiantao Rayxin Medical Products Co., Ltd. Disposable Surgical Face Mask Device: 510(k) number: K153496

### 9. Technological Characteristics Comparison Table

| Table 1 General Comparison | | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Proposed Device<br>K210744 | Predicate Device<br>K153496 | Comparison |
| Product<br>Name | Surgical Mask | Disposable Surgical Face<br>Masks | -- |
| Product<br>Code | FXX | FXX | Same |
| Regulation<br>No. | 21 CFR<br>878.4040 | 21 CFR 878.4040 | Same |
| Product<br>Class | II | II | Same |
| Product<br>Code | The Surgical Face Masks are<br>intended to be worn to protect both<br>the patient and healthcare personnel<br>from transfer of microorganisms,<br>body fluids and particulate material.<br>These face masks are intended for use<br>in infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a<br>single use, disposable device,<br>provided non-sterile | The Disposable Surgical Face<br>Masks are intended to be worn to<br>protect both the patient and<br>healthcare personnel from transfer<br>of microorganisms, body fluids and<br>particulate material. These face<br>masks are intended for use in<br>infection control practices to<br>reduce the potential exposure to<br>blood and<br>body fluids. This is a single use | Same |

#### Table 1 General Comparison

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| | | | disposable device(s), provided<br>non-sterile. | |
|------------------------|-------------------------------------------------|------------------------------------|------------------------------------------------|-----------|
| Design<br>features | Ear Loops, 3 layers | | Ear Loops, Tied-On, 3 layers | Same |
| Mask<br>Styles | Flat pleated | | Flat pleated | Same |
| Material | Outer<br>facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
| | Middle<br>layer | Melt blown polypropylene<br>filter | Melt blown polypropylene filter | Similar |
| | Inner<br>Facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
| | Nose<br>piece | Malleable aluminum wire | Malleable aluminum wire | Similar |
| | Ear<br>loops | Polyester | Polyester | Similar |
| Color | Blue | | Blue | Similar |
| Mask Size | M(152mmX70mm),L(175mmX90mm),<br>XL(180mmX100mm) | | 175mmX90mm | Different |
| OTC use | Yes | | Yes | Same |
| Sterility | Non-Sterile | | Non-Sterile | Same |
| Single Use | Yes | | Yes | Same |
| Sterile | No | | No | Same |
| ASTM<br>F2100<br>Level | Level 2 | | Level 2 | Same |

# Table2 Performance Characteristic Comparison

| ITEM | Proposed Device | Predicate Device | ASTM F2100<br>Requirements for<br>Level 2<br>Classification | Comparison |
|----------------------------------------------------|------------------------------------|----------------------------------|-------------------------------------------------------------|------------|
| Fluid Resistance<br>Performance ASTM<br>F1862-13 | 182 out of 182 pass<br>at 120 mmHg | 32 out of 32 pass at<br>120 mmHg | Pass at 120<br>mmHg* | Similar |
| Particulate Filtration<br>Efficiency<br>ASTM F2299 | 98.40% | 98.46% | ≥ 98%* | Similar |
| Bacterial Filtration<br>Efficiency ASTM F2101 | 99.86% | 98.70% | ≥ 98%* | Similar |
| Differential Pressure<br>(Delta P)<br>MIL-M-36954C | 5.3 mmH2O/cm2 | 4.2 mmH2O/cm2 | < 6.0<br>mmH2O/cm2* | Similar |

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| Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1* | Same |
|-----------------------------|---------|---------|----------|------|
|-----------------------------|---------|---------|----------|------|

* Acceptable sampling plans are found in ISO 2859-1 with an acceptable quality limit of 4 %

| ITEM | Proposed Device | Predicate Device | Biocompatibility<br>Requirement | Comparison |
|---------------|------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------|------------|
| Cytotoxicity | Under the conditions<br>of the study, not<br>cytotoxicity effect | Under the conditions<br>of the study, not<br>cytotoxicity effect | Comply with ISO<br>10993-5 | Similar |
| Irritation | Under the conditions<br>of the study, not an<br>irritant | Under the conditions<br>of the study, not an<br>irritant | Comply with ISO<br>10993-10 | Similar |
| Sensitization | Under conditions of<br>the study, not a<br>sensitizer | Under conditions of<br>the study, not a<br>sensitizer | | Similar |

# Table 3 Biocompatibility Comparison

# 10. Non-Clinical Test Conclusion

Non-clinical tests were conducted on three nonconsecutive lots to demonstrate that the proposed device met all design specifications or acceptance criteria in the standard and test methodology.

| Test Method | Purpose | Acceptance Criteria Level 2 | Results |
|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------|---------|
| ASTM F2100-19e1<br>ASTM F2101-19<br>Bacterial Filtration Efficiency Test<br>(BFE), % | The purpose of the testing<br>was to measure the<br>Bacterial Filtration Efficiency<br>Test | $\ge$ 98 | Pass |
| ASTM F2100-19e1<br>EN 14683:2019+AC:2019(E)<br>Annex C<br>Differential Pressure Test<br>(mm H2O/cm²) | The purpose of the testing<br>was to measure the<br>Differential Pressure Test | < 6.0 | Pass |
| ASTM F2100-19e1<br>ASTM F2299/F2299M- 2003(2017)<br>Sub-Micron Particulate Filtration<br>Efficiency (PFE) at<br>0.1 micron Test (%) | The purpose of the<br>testing was to measure<br>the Sub-Micron Particulate<br>Filtration Efficiency | $\ge$ 98 | Pass |

#### Table 1 Performance Test Result Summary

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| ASTM F2100- 19e1 ASTM<br>F1862/F1862M-17Resistance to<br>Penetration by Synthetic Blood Test<br>(minimum pressure in mmHg for pass<br>result) | The purpose of the testing<br>was to measure the<br>Penetration by Synthetic<br>Blood Test | 120 | Pass |
|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------|------|
| ASTM F2100-19e1<br>16 CFR Part 1610-2012<br>Flammability Test | The purpose of the testing<br>was to measure the<br>Flammability | Class 1 | Pass |

#### Table2 Biocompatibility Testing

| Item | Subject Device | Result |
|---------------|-----------------------------------------------------------------|--------|
| Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device is nonsensitizing | Pass |

#### 11. Clinical Test Conclusion

No clinical study is included in this submission.

#### 12. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Xianto Rayxin Medical Products Disposable Surgical Face Mask cleared under K153496.