Surgical Mask (Model: 0868F, 0866F)

K221173 · Jiangxi Sanhao Medical Instruments Co.,Ltd · FXX · Jul 6, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221173
• Device Name: Surgical Mask (Model: 0868F, 0866F)
• Applicant: Jiangxi Sanhao Medical Instruments Co.,Ltd
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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

Device Story

Surgical mask; flat-pleated; single-use; non-sterile. Three-layer construction: inner/outer layers polypropylene spunbond; middle layer melt-blown polypropylene. Includes polyethylene-coated iron wire nose piece; spandex ear loops. Available in blue (Model 0866F, Level 3) and black (Model 0868F, Level 1). Used in clinical settings by healthcare personnel and patients to provide barrier protection against microorganisms, body fluids, and particulates. Device worn over nose and mouth; nose piece adjusted for fit. Provides physical barrier; reduces potential exposure to blood/body fluids; aids infection control.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F2101 (BFE), ASTM F2299 (PFE), ASTM F1862 (synthetic blood penetration), and EN 14683 (differential pressure). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Three-layer mask: polypropylene spunbond (inner/outer), melt-blown polypropylene (middle). Nose piece: polyethylene-coated iron wire. Ear loops: spandex. Dimensions: 175mm x 95mm. Non-sterile. ASTM F2100 performance standards met. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices.

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

• Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) (K212293)
• Surgical mask (K211552)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.

July 6, 2022

Jiangxi SanHao Medical Instruments Co., Ltd % Ms. Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China

Re: K221173

Trade/Device Name: Surgical Mask (Model: 0868F, 0866F) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 14, 2022 Received: April 25, 2022

Dear Ms. Lee:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K221173

#### Device Name Surgical Mask (Model: 0868F, 0866F)

#### Indications for Use (Describe)

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

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

## 1. Submitter's Information

Sponsor Name: Jiangxi SanHao Medical Instruments Co.,Ltd Address: Chengxi Industrial Park, Jishui County, Ji'an City, Jiangxi Province. China Post Code: 331699 Contact name: Wangfenfang (General Manager) Tel: [phone] Phone: [phone] E-mail: [e-mail]

## Application Correspondent:

Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: [phone] Email: [e-mail]

### Date of the summary prepared: July 1, 2022

### 2. Subject Device Information

Common Name: Surgical Mask Classification Name: Mask, Surgical Trade Name: Surgical Mask Model Name: 0868F, 0866F Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: Class II

## 3. Predicate Device Information

Predicate Device 1 (Primary predicate device): Sponsor: Jiangmen Ningrui Medical Supplies Co., Ltd. Trade Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

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Classification Name: Mask, Surgical 510(k) Number: K212293 Review Panel: General Hospital Product Code: FXX Requlation Number: 21 CFR 878.4040 Requlation Class: II

#### Predicate Device 2 (Additional predicate device):

Sponsor: Shandong Shengquan New Materials Co., Ltd. Trade Name: Surgical mask Classification Name: Mask, Surgical 510(k) Number: K211552 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II

### 4. Device Description

The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the layers of the face mask is to allow the user to fit the face mask around their nose, which is made of polyethylene coated iron wire.

The mask will be provided in black and blue color, the colorant for the model 0868F is Carbon black (CAS No.1333-86-4), and for the model 0866F is Pigment Blue 15 (CAS No.147-14-8). The model 0866F will be provided in blue and labeled in Level 3, the model 0868F will be provided in black and labeled in Level 1.

### 5. Intended Use / Indications for Use

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

#### Comparison to predicate device and conclusion 6.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

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| Elements of<br>Comparison | Subject Device | Predicate Device 1 (Primary<br>predicate device) | Predicate<br>Device 2<br>(Additional<br>predicate<br>device) | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Company | Jiangxi SanHao<br>Medical<br>Instruments Co.,Ltd | Jiangmen Ningrui Medical<br>Supplies Co., Ltd. | Shandong<br>Shengquan<br>New Materials<br>Co., Ltd. | -- |
| 510 (k) | K221173 | K212293 | K211552 | -- |
| Trade Name | Surgical Mask | Surgical Mask | Surgical mask | -- |
| Model | 0868F, 0866F | WK1701-02A, WK1701-03A,<br>WK1701-04A | SMDP20608 | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Class II | Same |
| Product<br>Code | FXX | FXX | FXX | Same |
| Intended use | The Surgical Mask<br>is intended to be<br>worn to protect<br>both the patient<br>and healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids, and<br>particulate material.<br>The Surgical Mask<br>is intended for use<br>in infection control<br>practices to reduce<br>the potential<br>exposure to blood<br>and body fluids.<br>This is a single- | The Surgical Mask is intended<br>to be worn to protect both the<br>patient and healthcare<br>personnel from the transfer of<br>microorganisms, body fluids,<br>and particulate material. The<br>Surgical Mask is intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single-use, disposable<br>device(s), provided non-<br>sterile. | The surgical<br>masks are<br>intended to be<br>worn to protect<br>both the patient<br>and healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids and<br>particulate<br>material. These<br>surgical masks<br>are intended for<br>use in infection<br>control practices<br>to reduce the<br>potential | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 (Primary<br>predicate device) | Predicate<br>Device 2<br>(Reference<br>predicate<br>device) | Remark |
| | use, disposable<br>device, provided<br>non-sterile. | | exposure to<br>blood and body<br>fluids. This is a<br>single use,<br>disposable<br>device, and<br>provided non-<br>sterile. | |
| Materials | | | | |
| Outer facing<br>layer | Polypropylene<br>spunbond | Polypropylene spunbond<br>fabric | Polypropylene<br>Spunbond | Same |
| Middle filter<br>layer | Melt blown<br>polypropylene | Polypropylene spunbond<br>fabric | Melt blown<br>polypropylene<br>filter | Same |
| Inner facing<br>layer | Polypropylene<br>spunbond | Polypropylene spunbond<br>fabric | Polypropylene<br>Spunbond | Same |
| Nose piece | Polyethylene<br>coated iron wire | Polypropylene coated<br>galvanized iron wire | Malleable<br>polyethylene | Similar<br>Note 1 |
| Ear loops | Spandex | Nylon, spandex | Spandex,<br>Polyester | Similar<br>Note 1 |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | Same |
| Color | Blue (0866F),<br>Black (0868F) | Bule | Black and White | Similar<br>Note 1 |
| Dimensions | 175mm x 95mm<br>(±5mm)<br>Ear loop: 175mm<br>Nose piece: 80 ±<br>2mm | Length: 17.5 cm ±5mm<br>Width: 9.5 cm±3mm | Length:<br>17.5cm±0.88cm<br>Width:<br>9.5cm±0.48cm | Same<br>Note 1 |
| | OTC use | Yes | Yes | Yes |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single-use | Yes | Yes | Yes | Same |

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| Elements of<br>Comparison | Subject Device | Predicate Device 1 (Primary<br>predicate device) | Predicate Device 2<br>(Reference predicate<br>device) | Remark | | | |
|------------------------------------------------------------|----------------------------------|--------------------------------------------------|-------------------------------------------------------|-----------------------------|-------------------------------|-----------------------------------------------|-------------------|
| Performance<br>Testing | Level 1<br>(0868F) | Level 3<br>(0866F) | Level 1 | Level 2 | Level 3 | Level 3 | Same |
| Fluid<br>Resistance<br>Performance<br>(ASTM<br>F1862) | Pass at<br>80 mmHg | Pass at<br>160 mmHg | Pass at<br>80 mm Hg | Pass at<br>120 mm Hg | Pass at<br>160 mm Hg | Passed at 29<br>out of 32 pass<br>at 160 mmHg | Same |
| Particulate<br>Filtration<br>Efficiency<br>(ASTM<br>F1215) | Pass at<br>$\ge$ 95% | Pass at<br>$\ge$ 98% | Pass at<br>$\ge$ 99% | Pass at $\ge$<br>99% | Pass at<br>$\ge$ 99% | $\ge$ 98% | Similar<br>Note 2 |
| Bacterial<br>Filtration<br>Efficiency<br>(ASTM<br>F2101) | Pass at<br>$\ge$ 95% | Pass at<br>$\ge$ 98% | Pass at<br>$\ge$ 99% | Pass at $\ge$<br>99% | Pass at<br>$\ge$ 99% | $\ge$ 98% | Similar<br>Note 2 |
| Differential<br>Pressure<br>(ASTM<br>F2100) | Pass at<br>$<$ 5.0 mm<br>H2O/cm² | Pass at<br>$<$ 6.0 mm<br>H2O/cm² | Pass at<br>$<$ 3.4 mmH2O /cm² | Pass at <<br>3.5 mmH2O /cm² | Pass at<br>$<$ 3.4 mmH2O /cm² | $<$ 6.0 mm<br>H2O/cm² | Similar<br>Note 2 |
| Flammability | Class 1 | Class 1 | Class 1 | | | Same | |
| Biocompatibility | | | | | | | |
| Cytotoxicity | Non-cytotoxic | | Non-cytotoxic | | | Conform to ISO<br>10993-<br>5:2009 | Same |
| Irritation | Non-irritating | | Non-irritating | | | Conform to ISO<br>10993-<br>10:2010 | Same |
| Sensitization | Non-sensitizing | | Non-sensitizing | | | Conform to ISO<br>10993- | Same |

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| Elements of<br>Comparison | Subject Device | Predicate Device 1 (Primary<br>predicate device) | Predicate<br>Device 2<br>(Reference<br>predicate<br>device) | Remark |
|---------------------------|----------------|--------------------------------------------------|-------------------------------------------------------------|--------|
| | | | 10:2010 | |

## Comparison in Detail(s):

### Note 1:

Although the Materials of "Nose piece", "Ear loops", "Color" and "Dimensions" of subject device are a little different from the predicate devices, they all met the requirements of biocompatibility standards ISO 10993-5 and ISO 10993-10. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

## Note 2:

Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of the subject device are a little different from predicate devices, they all met the requirements of performance standard ASTM F2100. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

#### 7. Summary of Non-Clinical Performance Testing

## Performance Testing Summary

| Test item | Test method | Pass criteria | | Test results/Verdict |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------|----------------------|
| | | For Level 1 | For Level 3 | |
| Bacterial<br>filtration<br>efficiency | ASTM F2101-19 Standard Test<br>Method for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of Medical<br>Face Mask Materials, Using a<br>Biological Aerosol of Staphylococcus<br>aureus according to ASTM F2100:<br>2019 | ≥ 95% | ≥ 98% | Pass |
| Differential<br>pressure | EN 14683: 2019, Annex C Medical<br>face masks - Requirements and test | <5.0 mm<br>H2O/cm² | <6.0 mm<br>H2O/cm² | Pass |

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| (Delta-P) | methods according to ASTM F2100:<br>2019 | | | |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------|------|
| Sub-micron<br>particulate<br>filtration<br>efficiency at 0.1<br>µm of<br>Polystyrene<br>Latex Spheres | ASTM F2299 Standard Test Method<br>for Determining the Initial Efficiency of<br>Materials Used in Medical Face Masks<br>to Penetration by Particulates Using<br>Latex Spheres according to ASTM<br>F2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Resistance to<br>penetration by<br>synthetic blood,<br>minimum<br>pressure in mm<br>Hg for pass<br>result | ASTM F1862/F1862M-17<br>Standard Test Method for Resistance of<br>Medical Face Masks to Penetration by<br>Synthetic Blood (Horizontal Projection of<br>Fixed Volume at a Known Velocity)<br>according to ASTM F2100:2019 | Pass<br>at 80 mm<br>Hg | Pass<br>at 160 mm<br>Hg | Pass |
| Flame spread | 16 CFR Part 1610 Standard for the<br>Flammability of Clothing according to<br>ASTM F2100:2019 | Class 1 | Class 1 | Pass |

# Biocompatibility Testing Summary

According to ISO 10993-1: 2018, the nature of body contact for the subject device is direct surface contact with skin and indirect contact with the respiratory tract, and the duration of the contact is A-Limited (<24 h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

| Title of the test | Purpose of the test | Reference for<br>Test method | Acceptance<br>criteria | Test<br>results |
|-------------------|---------------------|------------------------------|------------------------|-----------------|
|-------------------|---------------------|------------------------------|------------------------|-----------------|

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| In vitro<br>Cytotoxicity Test | Under the research<br>conditions,<br>determine whether<br>the target device<br>extract is cytotoxic. | ISO 10993-5:2009<br>Biological evaluation<br>of medical devices-<br>Part 5: Tests for in<br>vitro cytotoxicity | Under the<br>conditions of the<br>study, the subject<br>device extract was<br>determined to be<br>non-cytotoxic. | Pass |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------|
| Skin<br>Sensitization<br>Test | Under the research<br>conditions,<br>determine whether<br>the non-polar and<br>polar extracts of<br>the target device<br>are sensitive. | ISO 10993-10:2010<br>Biological evaluation<br>of medical devices-<br>Part 10: Tests for<br>irritation and skin<br>sensitization | Under the<br>conditions of the<br>study, the subject<br>device non-polar<br>and polar extracts<br>were determined to<br>be non-sensitizing. | Pass |
| Skin Irritation<br>Test | Under the research<br>conditions,<br>determine whether<br>the non-polar and<br>polar extracts of<br>the target device<br>are irritating. | ISO 10993-10:2010<br>Biological evaluation<br>of medical devices-<br>Part 10: Tests for<br>irritation and skin<br>sensitization | Under the<br>conditions of the<br>study, the subject<br>device non-polar<br>and polar extracts<br>were determined to<br>be non-irritating. | Pass |

# 8. Summary of Clinical Performance Test

No clinical study is included in this submission.

## 9. Final Conclusion:

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K212293 and K211552.