Medical Surgical Mask

K213724 · Hunan Zhenheyikang Medical Instrument Co., Ltd. · FXX · Feb 20, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213724
• Device Name: Medical Surgical Mask
• Applicant: Hunan Zhenheyikang Medical Instrument Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Feb 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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(s), provided as sterile.

Device Story

Medical Surgical Mask; single-use, three-layer, flat-pleated face mask. Components: inner/outer polypropylene layers; middle melt-blown polypropylene filter; galvanized iron wire nose piece; elastic ear loops (polyester/spandex). Device worn over mouth and nose to provide barrier protection against microorganisms, body fluids, and particulates. Used in clinical settings for infection control. Healthcare personnel and patients wear device to reduce cross-contamination and exposure to blood/body fluids. Sterile, disposable, and intended for single use.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated against ASTM F2100-19 Level 3 standards, including Fluid Resistance (ASTM F1862), Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (MIL-M-36954C), and Flammability (16 CFR 1610). Biocompatibility testing (Cytotoxicity, Irritation, Sensitization) passed.

Technological Characteristics

Three-layer flat-pleated mask. Materials: Polypropylene (inner/outer), melt-blown polypropylene (filter), galvanized iron wire (nose piece), polyester/spandex (ear loops). Sterilization: Ethylene oxide gas (SAL 10^-6). Performance: ASTM F2100 Level 3. No software or electronic components.

Indications for Use

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

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 (K211454)

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). 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.

February 20, 2022

Hunan Zhenheyikang Medical Instrument Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K213724

Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 10, 2022 Received: February 16, 2022

Dear Boyle 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 Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K213724

Device Name Medical Surgical Mask

#### Indications for Use (Describe)

Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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(s), provided as 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 K213724

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

#### 1.0 submitter's Information

Name: HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD

Address: No.6 Building Jingxiang Energy,No.55 Xiaguang East Road,Gaoxin District, Xiangtan, Hunan, China

Tel:[phone]

Contact: Yilin Yin

Date of Preparation: Nov.12, 2021

#### Designated Submission Correspondent

Mr. Boyle Wang

Shanghai Truthful Information Technology Co., Ltd.

Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: [phone]

Email: [e-mail]

#### 2.0 Device Information

Trade name: Medical Surqical Mask Common name: Surgical Face Mask Classification name: Surgical Face Mask Model: Ear-loop Type

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#### 3.0 Classification

Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II

Panel: Surgical Apparel

#### 4.0 Predicate Device Information

Manufacturer: Jiangsu Xingtong Biotechnology Group Co., Ltd. Device: Surgical mask

510(k) number: K211454

#### 5.0 Device Description

The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of 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 not made with natural rubber latex. The nose piece in the lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.

#### 6.0 Indication for Use Statement

The Medical Surgical Mask is 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 as sterile.

#### 7.0 Technological Characteristic Comparison

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| Item | Subject Device | Predicate Device | Comparison | |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | K213724 | K211454 | | |
| Product Name | Medical Surgical Mask | Surgical mask | -- | |
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| Intended Use&<br>Indications for use | Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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(s), | The surgical 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, | Same | |
| | | | provided as sterile. | |
| | | | disposable device,<br>provided as sterile. | |
| Design features | | Ear Loops,<br>3 layers | Ear loops: XT10A1; Tie-on: XT10B1;<br>3 layers | Different<br>Analysis 1 |
| Mask Styles | | Flat pleated | Flat pleated | Same |
| Material | Outer<br>facing<br>layer | Polypropylene | Polypropylene | Same |
| | Middle<br>layer | Melt-blown cloth<br>(polypropylene) | Melt-blown cloth<br>(polypropylene) | Same |
| | Inner<br>Facing<br>layer | Polypropylene | Polypropylene | Same |
| | Nose<br>piece | Galvanized iron wire | Polyethylene coated<br>steel wire | Different<br>Analysis 1 |
| | Ear<br>loops | 78% Polyester + 22%<br>spandex | -Ear loops: Polyester silk &<br>Polyurethane filament | Similar<br>Analysis 1 |
| Color | | Blue | Blue | Same |
| Dimension | | 175mm×95mm±5% | Mask body for ear-loop<br>type: 17.5cm×9.5cm &<br>14.5cm×9.5cm<br>Mask body for Tie-on type:<br>17.5cm×9.5cm | Similar<br>Analysis2 |
| OTC use | | Yes | Yes | Same |
| Shelf life | | 2 years | 2 years | Same |
| Single Use | | Yes | Yes | Same |
| Sterility | | Sterile | Sterile | Same |
| Sterilization<br>method and<br>S.A.L. | | Sterilized by ethylene oxide<br>gas, SAL=10-6 | Sterilized by ethylene oxide<br>gas, SAL=10-6 | Same |
| ASTM F2100 Level | | Level 3 | Level 3 | Same |
| Bacterial filtration<br>efficiency (BFE) (%) | Lot 1# 31 Out of 32 pass at<br>160mmHg (21.3 kPa);<br>Lot 2# 31 Out of 32 pass at<br>160mmHg (21.3 kPa);<br>Lot 3# 32 Out of 32 pass at<br>160mmHg (21.3 kPa). | Lot 1# pass at 160mmHg;<br>Lot 2# pass at 160mmHg;<br>Lot 3# pass at 160mmHg. | Similar | |
| Different pressure<br>(mmH2O/cm²) | Lot1#99.02%-99.58%;<br>Lot2#99.05%-99.59%;<br>Lot3#99.10%-99.68%. | Lot 1# 99.7%-99.9%;<br>Lot 2# 99.7%-99.9%;<br>Lot 3# 99.7%-99.9%. | Similar | |
| Sub-micron particulate<br>filtration efficiency at<br>0.1 micron, % (PFE) | Lot1#98.8%-99.7%;<br>Lot2#98.7%-99.5%;<br>Lot3#98.9%-99.5%. | Lot 1# 99.2%-99.8%;<br>Lot 2# 99.0%-99.7%;<br>Lot 3# 99.3%-99.7%. | Similar | |
| Resistance to<br>penetration by<br>synthetic blood,<br>Minimum pressure<br>in mmHg for pass<br>result | Lot1#1.66-4.44mmH20/cm²<br>Lot2#1.63-4.24mmH20/cm²<br>Lot3#1.60-4.43mmH20/cm² | Lot 1# 2.3-4.6;<br>Lot 2# 2.3-4.5;<br>Lot 3# 2.0-3.9 | Similar | |
| Flame spread | Lot 1# Class I;<br>Lot 2# Class I;<br>Lot 3# Class I | Lot 1# Class I;<br>Lot 2# Class I;<br>Lot 3# Class I | Same | |
| Item | Purpose | Acceptance<br>Criteria | Result | |
| Fluid Resistance<br>Performance ASTM<br>F1862 | The purpose of the<br>methodology is to<br>evaluate the Fluid<br>Resistance | 29 Out of 32 pass at 120<br>mmHg (21.3 kPa) | Pass<br>Lot 1# 31 Out of 32 pass<br>at 160mmHg (21.3 kPa)<br>Lot 2# 31 Out of 32 pass<br>at 160mmHg (21.3 kPa)<br>Lot 3# 32 Out of 32 pass<br>at 160mmHg (21.3 kPa) | |
| Particulate<br>Filtration Efficiency<br>ASTM F2299 | The purpose of the<br>methodology is to<br>evaluate the<br>Particulate Filtration<br>Efficiency | ≥ 98% | Pass<br>Lot1#99.02%-99.58%;<br>Lot2#99.05%-99.59%;<br>Lot3#99.10%-99.68% | |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101 | The purpose of the<br>methodology is to<br>evaluate the Bacterial<br>Filtration Efficiency | ≥ 98% | Pass<br>Lot1#98.8%-99.7%;<br>Lot2#98.7%-99.5%;<br>Lot3#98.9%-99.5% | |
| Differential<br>Pressure<br>(Delta P) MILM- 36954C | The purpose of the<br>methodology is to<br>evaluate the<br>Differential Pressure<br>(Delta P) | < 6.0 mmH20/cm² | Pass<br>Lot1#1.66-<br>4.44mmH20/cm²<br>Lot2#1.63-<br>4.24mmH20/cm²<br>Lot3#1.60-<br>4.43mmH20/cm2 | |
| Flammability<br>16 CFR 1610 | The purpose of the<br>methodology is to<br>evaluate the<br>Flammability | Class 1 | Pass,<br>Class 1 | |

# Table 1 General Comparison

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Analysis1: the two devices have some difference in design features and materials, product materials safety is proved by its biocompatibility.

Analysis2: the two devices share same dimensions otherwise the tolerance is different.

Analysis 3: The two devices have some little deviation in product performance, but the difference in the performance test result does not raise additional questions for safety and effectiveness since the two device performance results both meet the requirements of ASTM F2100-19, level 3.

# 8.0 Non-Clinical Test Conclusion

The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.

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### Table 2 - Performance Testing

# Table 3 - Biocompatibility Testing

| tom<br>ﻟﺘﺎﺭﻳﺦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ | Purpose | Result |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------|

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| Cytotoxicity | The purpose of the methodology is to<br>evaluate the Cytotoxicity endpoint. | Pass<br>Under the conditions of the study,<br>the subject device was non-<br>cytotoxic |
|---------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Irritation | The purpose of the methodology is to<br>evaluate the Irritation endpoint. | Pass<br>Under the conditions of the study,<br>the subject device was non-irritating |
| Sensitization | The purpose of the methodology is to<br>evaluate the Sensitization endpoint. | Pass<br>Under the conditions of the study,<br>the subject device was non-<br>sensitizing |

#### 9.0_Clinical Test Conclusion

No clinical study is included in this submission.

#### 10.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K211454.