Surgical Face Mask

K211631 · Macheng Thimble Technology Investment Co., Ltd. · FXX · Aug 18, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211631
• Device Name: Surgical Face Mask
• Applicant: Macheng Thimble Technology Investment Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Aug 18, 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 a single use, disposable device(s), provided non-sterile.

Device Story

Surgical face mask; blue, flat-pleated design; ear loops; malleable aluminum nose piece. Three-layer construction: outer/inner layers spun-bond polypropylene; middle layer melt-blown polypropylene filter. Single-use, disposable, non-sterile. Worn by patients and healthcare personnel to provide barrier protection against microorganisms, body fluids, and particulates. Used in clinical settings for infection control. Protects wearer and patient by reducing exposure to blood and body fluids.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Three-layer mask: spun-bond polypropylene (outer/inner), melt-blown polypropylene (middle). Malleable aluminum nose clip. Polyester ear loops. Non-sterile. Dimensions: 17.5cm x 9.5cm. Complies with ASTM F2100 (Level 2/3), ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, and 16 CFR 1610. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for use by patients and healthcare personnel to reduce transfer of microorganisms, body fluids, and particulate material, and to reduce exposure to blood and body fluids in 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 Face Mask (non-sterile ) (K203426)

Submission Summary (Full Text)

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August 18, 2021

Macheng Thimble Technology Investment Co., Ltd % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai 200122 China

Re: K211631

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: May 27, 2021 Received: May 27, 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 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,

For Clarence W. Murray III, Ph.D. 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) K211631

Device Name Surgical Face 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 a single use, disposable device(s), 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

#### 510(k) Number : K211631 Date Prepared:2021/8/18

#### A. Applicant:

Manufacturer: Macheng thimble Technology Investment Co., Ltd Address: No. 7 Xiling 2nd Rd, Macheng Economic Development Zone, Hubei Province Owner number: 3016965655 Contact Person: Donghong SHENG Address: No. 7 Xiling 2nd Rd, Macheng Economic Development Zone, Hubei Province Tel: [phone] Mail: [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:

Proprietary Name: Surgical Face Mask Common Name: Surgical Face Mask Model(s): Ear loops

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

#### C. Predicate device:

510(k) Number: K203426 Sponsor: Nantong Taiweishi Medical Technology Co., Ltd. Trade Name: Surgical Face Mask (non-sterile ) (Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)

#### D. Device Description:

The Surgical Face Masks are blue, flat pleated masks with ear loops to hold the device in place over the user's mouth and nose and a nose piece to fit the mask to the face. The proposed device(s) 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 polyester. They are not made

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with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

### E. Indications use of the device:

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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

### F. Comparison with predicate device

Table 1 General Comparison

| Device | Proposed Device | Predicate device | Comparison | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------|
| Manufacturer | MACHENG THIMBLE<br>TECHNOLOGY INVESTMENT CO.,<br>LTD | Nantong Taiweishi Medical<br>Technology Co., Ltd. | - | |
| 510K number | K211631 | K203426 | - | |
| Device name | Surgical Face Mask | Surgical Face Mask (non-sterile ) | - | |
| Classification | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Indications for use | The Surgical Face Masks are intended<br>to be worn to protect both the patient<br>and healthcare personnel from transfer<br>of microorganisms, body fluids and<br>particulate material. These face masks<br>are intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and body<br>fluids. This a single use, disposable<br>device(s), provided non-sterile. | The Disposable Surgical Face Masks are<br>intended to be worn to protect both the<br>patient and healthcare personnel from<br>transfer of microorganisms, body fluids and<br>particulate material. These face masks are<br>intended for use in infection control<br>practices to reduce the potential exposure to<br>blood and body fluids. This is a single use,<br>disposable device(s), provided<br>non-sterile. | Same | |
| M<br>at<br>er<br>ial | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| | Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose clip | Malleable aluminum wire | Polyethylene | Different |
| | Ear loops | Polyester | Nylon and Spandex | Different |
| Color | Blue | Blue | Same | |
| | Dimension<br>(length) | $17.5cm+/-0.5cm$ | $175mm+/-5%$ | Similar |
| | Dimension<br>(Width) | $9.5cm+/-0.5cm$ | $95mm+/-5%$ | Similar |
| | OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 2&3 | Level 2 | Similar | |
| Biocompatibility | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Same | |

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From the comparison we found the material of the current nose clip and the ear loop were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.

The level of the proposed device is different from the predicate device, the main performance for level 3 surgical face mask is the requirement of Fluid Resistance, the performance has conducted and the the requirement of Level 2 and level 3 medical mask according to the ASTM F 2100.

#### Table 2 performance testing comparison

| Item | Proposed device | Predicate device | Result |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------|
| Fluid Resistance<br>Performance ASTM<br>F1862 | 32 out of 32 per lot pass at 120 mmHg, 3<br>non-consecutive lots tested;<br>32 out of 32 per lot pass at 160 mmHg for 2<br>non-consecutive lots tested;<br>30 out of 32 per lot pass at 160 mmHg for 1 lot tested. | 32 out of 32 pass<br>at 120 mmHg | Pass |
| Particulate<br>Filtration<br>Efficiency ASTM F2299 | 99.65% | 99.16% | Pass |
| Bacterial<br>Filtration<br>Efficiency ASTM F2101 | 99.76% | 99.74% | Pass |
| Differential<br>Pressure<br>(Delta P) EN 14683<br>Annex C | 4.2 mmH2O/cm² | 3.7 mmH2O/cm² | Pass |
| Flammability 16 CFR<br>1610 | Class 1 | Class 1 | Pass |

### G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar 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 Vitro A Cytotoxicity
- > 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
- A 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);

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- EN 14683, Medical Face Masks-Requirements and Test Methods; A
- 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, Stand 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; >

| | Table 3 - Biocompatibility Testing | |
|--|------------------------------------|--|
| | | |

| Test Method | Purpose | Acceptance Criteria | Result |
|---------------|-----------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------|
| Cytotoxicity | The purpose of the<br>biocompatibility testing is<br>to demonstrate the<br>biocompatibility<br>of the subject device. | Non-Cytotoxic | PASS<br>Under the conditions of the<br>study, the device is non-<br>cytotoxic. |
| Irritation | | Non-Irritating | PASS<br>Under the conditions of the<br>study, the device is non-<br>irritating. |
| Sensitization | | Non-Sensitizing | PASS<br>Under the conditions of the<br>study, the device is non-<br>sensitizing |

Table 4 – Performance Testing

| Test Method | Purpose | Acceptance Criteria | Result |
|-------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance<br>Performance<br>ASTM F1862 | | 29 out of 32 pass at<br>120 mmHg for Level 2<br>29 out of 32 pass at<br>160 mmHg for Level 3 | PASS<br>32 out of 32 per lot pass at 120<br>mmHg, 3 non-consecutive lots<br>tested;<br>32 out of 32 per lot pass at 160<br>mmHg for 2<br>non-consecutive lots tested;<br>30 out of 32 per lot pass at 160<br>mmHg for 1 lot tested. |
| Particulate<br>Filtration<br>Efficiency ASTM<br>F2299 | The purpose of<br>the performance<br>testing is to | ≥ 98% | PASS<br>3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot1: 99.79%<br>Lot2: 99.58%<br>Lot3: 99.6% |

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| Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | demonstrate the<br>functionality of<br>the subject<br>device. | ≥ 98% | PASS<br>3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot1: 99.56%<br>Lot2: 99.9%<br>Lot3: 99.84% |
|-----------------------------------------------------------|---------------------------------------------------------------|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Differential<br>Pressure (Delta P)<br>EN 14683<br>Annex C | | < 6.0mmH2O/cm² | PASS<br>3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Lot1: 5.2 mmH2O/cm²<br>Lot2: 3.8 mmH2O/cm²<br>Lot3: 3.8 mmH2O/cm² |
| Flammability 16<br>CFR 1610 | | Class 1 | PASS<br>3 non-consecutive lots tested,<br>using a sample size of 32/lot.<br>Class 1 |

### H. Clinical Test Conclusion

No clinical study is included in this submission.

### I. Conclusion

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device Nantong Taiweishi Medical Technology Co., Ltd. Surgical Face Mask

( non-sterile ) .