Disposable Surgical Mask (non sterile)

K211451 · Qinhuangdao Taizhi Medical Technology Co., Ltd. · FXX · Aug 25, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211451
• Device Name: Disposable Surgical Mask (non sterile)
• Applicant: Qinhuangdao Taizhi Medical Technology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Aug 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Disposable surgical mask (non sterile) 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 non sterile.

Device Story

Disposable, three-layer, flat-pleated surgical mask; worn by healthcare personnel and patients. Constructed of spun-bond polypropylene (inner/outer layers) and melt-blown polypropylene (middle layer); includes PE-coated dual-galvanized wire nose piece and nylon/spandex ear straps. Used in clinical settings for infection control; provides physical barrier against microorganisms, body fluids, and particulates. Single-use; non-sterile. User fits mask over nose and mouth using nose piece and ear straps. Benefits include reduced risk of cross-contamination and exposure to blood/body fluids.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19 Level 2 standards: Bacterial Filtration Efficiency (99.9%), Differential Pressure (2.8-3.6 mmH2O/cm²), Sub-micron Particulate Filtration Efficiency (99.48-99.95%), Synthetic Blood Penetration Resistance (32/32 passed at 120 mmHg), and Flame Spread (Class 1). Biocompatibility testing confirmed device is non-cytotoxic, non-irritating, and non-sensitizing.

Technological Characteristics

Three-layer flat-pleated mask. Materials: Spun-bond polypropylene (inner/outer), melt-blown polypropylene (middle), PE-coated dual-galvanized wire (nose piece), nylon/spandex (ear straps). Dimensions: 17.5cm x 9.5cm. Performance: ASTM F2100-19 Level 2. Non-sterile, single-use.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against 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 (K182515)

Submission Summary (Full Text)

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August 25, 2021

Qinhuangdao Taizhi Medical Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K211451

Trade/Device Name: Disposable Surgical Mask (non sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 21, 2021 Received: July 29, 2021

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.

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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 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.

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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211451

#### Device Name Disposable surgical mask (non sterile)

#### Indications for Use (Describe)

Disposable surgical mask (non sterile) 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 non sterile.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

_ | 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 requirements of SMDA 1990 and 21 CFR 807.92.

#### 1.0 Submitter's information

Name: Qinhuangdao Taizhi Medical Technology Co., Ltd. Address: No.5, Small and Medium Enterprises Incubator Base, East Circular Economy Park, Haigang District, Qinhuangdao City, Hebei Province, China Phone Number: [phone] Contact: Ms. Fan Xifan Date of Preparation: 16/04/2021

#### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

#### 2.0 Device information

Trade name: Disposable surgical mask (non sterile) Common name: Surgical face mask Classification name: Mask, Surgical Model(s): ear strap, 175×95mm

# 3.0 Classification

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

#### 4.0 Predicate device information

Manufacturer: Wuhan Dymex Healthcare Co., Ltd Device: Surgical Face Mask 510(k) number: K182515

#### 5.0 Indication for Use Statement

Disposable surqical mask (non sterile) is intended to be worn to protect both the patient

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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 non sterile.

### 6.0 Device description

The Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

| Table 1 - General Comparison | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Item | Proposed device | Predicated device | Remark |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product name | Disposable surgical mask<br>(non sterile) | Surgical Face Mask | - |
| 510(k) No. | K211451 | K182515 | - |
| Models | ear strap, 175×95mm | ear strap | - |
| Intended Use<br>/ Indications for Use | The Disposable surgical<br>mask (non sterile) is<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. It 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 Face Masks<br>are intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices to<br>reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non-sterile. | Same |
| OTC use | Yes | Yes | Same |
| Composite | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Same |

#### ﮯ ﺎ ﺍ Tahlo 1

7.0 Comparison of Technological Characteristic

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| Material | Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
|-----------------------|--------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------|
| | Middle layer | Melt blown polypropylene | Melt blown polypropylene | Same |
| | External layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose piece | PE (polyethylene) with dual-Galvanized wire | Malleable polyethylene wire | Different * (Gap 1) |
| | ear strap | Nylon, spandex | spandex | Different * (Gap 2) |
| | Color | Blue | Yellow | Different * (Gap 3) |
| | Dimension (Length) | $17.5cm\pm0.5cm$ | $17.5cm\pm0.2cm$ | Different* (Gap 4) |
| | Dimension (Width) | $9.5cm\pm0.5cm$ | $9.5cm\pm0.2cm$ | Different * (Gap 5) |
| | Sterility | Non-Sterile | Non-Sterile | Same |
| | Single Use | Yes | Yes | Same |
| | Sterile | No | No | Same |
| | ASTM F2100 Level | Level 2 | Level 2 | Same |
| Biocompati<br>-bility | Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Under the conditions of the study, the device is noncytotoxic. | Same |
| | Irritation | Under the conditions of the study, the device is nonirritating. | Under the conditions of the study, the device is nonirritating. | Same |
| | Sensitization | Under the conditions of the study, the device is nonsensitizing | Under the conditions of the study, the device is nonsensitizing | Same |

* Gap analysis:

Gap 1-3: the two devices have some difference in materials and product color, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectiveness of device.

Gap 4-5: the two devices share same dimensions otherwise the tolerance is different, the little deviation in tolerance does not raise additional questions for safety and effectiveness of device.

# 8.0 _Non-Clinical Test Conclusion

The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical face masks

- Premarket Notification [510(k)] Submission issued on March 5, 2004.

# Table 2 - Performance Testing

| Items | Performance | Acceptance Criteria | Result |
|-------|-------------|---------------------|--------|
|-------|-------------|---------------------|--------|

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| | | (Level 2, ASTM<br>F2100-19) | |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------|------|
| Bacterial filtration<br>efficiency (BFE) (%) | 99.9% | ≥98 | Pass |
| Different pressure<br>(mmH2O/cm²) | 2.8-3.6 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
| Sub-micron particulate<br>filtration efficiency at 0.1<br>micron, % (PFE) | 99.48~99.95% | ≥98 | Pass |
| Resistance to penetration<br>by synthetic blood,<br>Minimum pressure in<br>mmHg for pass result | Test 1-3: 32 of 32 test<br>articles passed at<br>120mmHg; | 29 of 32 test articles<br>passed at 120mmHg | Pass |
| Flame spread | Class 1, Non Flammable | Class 1 | Pass |

#### Table 3 - Biocompatibility Testing

| Item | Proposed 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 |

# 9.0 _Clinical Test Conclusion

No clinical study implemented for the Disposable surgical mask (non sterile).

#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K182515.