Disposable Medical Surgical Mask

K201625 · Tianjin Saiyuan Technology Co., Ltd. · FXX · Jan 12, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K201625
• Device Name: Disposable Medical Surgical Mask
• Applicant: Tianjin Saiyuan Technology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jan 12, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Device Story

Disposable, three-layer, flat-folded surgical mask; worn by healthcare personnel and patients. Constructed with spunbond polypropylene inner/outer layers and melt-blown polypropylene filter middle layer; includes malleable polyethylene nose piece and spandex/nylon ear loops. Used in clinical settings for infection control to reduce exposure to blood, body fluids, and particulates. Device acts as a physical barrier; performance verified via ASTM F2100-19 standards. Non-sterile, single-use.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19, ASTM F1862 (fluid resistance ≥160 mmHg), ASTM F2299 (particulate filtration ≥98%), ASTM F2101 (bacterial filtration ≥98%), MIL-M-36954C (differential pressure <6.0 mmH2O/cm²), and 16 CFR 1610 (flammability Class 1). Biocompatibility testing (cytotoxicity, irritation, sensitization) passed per ISO 10993.

Technological Characteristics

Three-layer flat-folded mask. Materials: Spunbond polypropylene (inner/outer), melt-blown polypropylene (filter), malleable polyethylene wire (nose piece), spandex/nylon (ear loops). Dimensions: 9.5cm x 17.0cm. ASTM F2100 Level 3 barrier protection. Non-sterile, single-use.

Indications for Use

Indicated for use by healthcare personnel and patients to protect against transfer of microorganisms, blood, body fluids, and particulate material 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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January 12, 2021

Tianjin Saiyuan Technology CO., LTD % Wang Yanhong RA Engineer Andon Health Co.. Ltd No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China

Re: K201625

Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 23, 2020 Received: October 26, 2020

Dear Wang Yanhong:

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,

For CAPT Elizabeth Claverie, MS 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) K201625

Device Name

Disposable Medical Surgical Mask (rectangular)

#### Indications for Use (Describe)

The Disposable Medical Surgical Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce 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)

| | Dissemination Use (Ref 21 CFR 601.2 Subpart D) |
|--|-----------------------------------------------------|
| | Own-Use; Compassionate Use (21 CFR 601.2 Subpart E) |

_ | 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 SMDA and 21 CFR 807.92.

### 1.0 submitter's information

Name: TIANJIN SAIYUAN TECHNOLOGY CO.,LTD Address: 18 DongJiu Street, Zhongxin Road, Pilot Free Trade Zone (Airport Economic Area) , Tianjin, CN 300308

Phone number: 86-22-60406905 86-22-60406912 Fax number: Contact: Hong Cai Date of Preparation: 1/11/2021

#### 2.0 Device information

Trade name: Disposable Medical Surgical Mask (rectangular) Common name: surgical mask Regulation Name: Surgical Apparel

## 3.0 Classification

Production code: FXX Regulation number: 21 CFR §878.4040 Classification: II Panel: General Hospital

#### 4.0 Predicate device information

Manufacturer: WUHAN DYMEX HEALTHCARE CO., LTD Device: SURGICAL FACE MASK 510(k) number: K182515

#### 5.0 Intended use

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The Disposable Medical Surqical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

# 6.0 Device description

The Disposable Medical Surgical Mask (rectangular) is single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The mask is held in place by the elastic ear loops. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile.

This device is not made from Natural Rubber Latex.

| Item | Subject Device | Predicate Device (K182515) | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Manufacturer | TIANJIN SAIYUAN<br>TECHNOLOGY CO.,LTD | WUHAN DYMEX<br>HEALTHCARE<br>CO., LTD | Different note 1 |
| 510K number | K201625 | K182515 | Different note 2 |
| Product name | Surgical mask | Surgical face mask | Different note 3 |
| classification | Class II device, FXX (21 CFR<br>878.4040) | Class II device, FXX (21 CFR<br>878.4040) | Same |
| Indications for<br>Use | The Disposable Medical Surgical<br>Mask is intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>blood, body fluids and particulate<br>material. This surgical mask is<br>intended for use in infection<br>control practices to reduce | The Surgical Face Masks are<br>intended to be worn to protect<br>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 | Same |

# 7.0 Summary comparing technological characteristics with predicate device

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| | potential exposure to blood and<br>body fluids. This is a single use,<br>disposable device, provided<br>non-sterile. | reduce the potential exposure<br>to blood and body fluids. This<br>is a single use, disposable<br>device(s), provided non-sterile. | |
|---------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Model | rectangular | Ear loops, flat pleated, 3 layers | Different note 4 |
| materials | Outer facing layer:<br>Spun-bond polypropylene | Outer facing layer:<br>Spun-bond polypropylene | Same |
| | Middle facing layer:<br>Melt blown polypropylene filter | Middle facing layer:<br>Melt blown polypropylene filter | Same |
| | Inner facing layer:<br>Spun-bond polypropylene | Inner facing layer:<br>Spun-bond polypropylene | Same |
| | Nose piece:<br>Malleable polyethylene wire | Nose piece:<br>Malleable polyethylene wire | Same |
| | Ear loops:<br>Spandex and nylon | Ear loops:<br>Spandex | Different note 5 |
| | | | |
| Color | Outside: Blue<br>Inside: white | Yellow | Different note 6 |
| Dimension(Width) | 9.5cm±1cm | 9.5cm±1cm | Same |
| Dimension(Length) | 17.0cm±1cm | 17.5cm±1cm | Different note 7 |
| Mask style | flat-folded | flat-folded | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100<br>Level | Level 3 | Level 2 | Different note 8 |

Note 1-4: the manufacturer is different, so the device name, 510K number and model number is different. The performance test conform that the new device is the same safe and effective as the predicate device.

Note 5: There is nylon material in the ear loop of the proposed device, which is different from the predicate device, however, Nylon is a popular material used in cloths, and the biocompatibility test also demonstrated the material is as safe as the predicate device.

Note 6: The color of the outer facing layer is different from the predicate device, but the biocompatibility test also demonstrated the material is as safe as the predicate device.

Note 7: Dimension of width is the same as the predicate device, while dimension of length of is different, the performance test proves the device is the same safe and effective as the predicate device.

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Note 8: The new device is level 3 according to ASTM F2100 standard, the performance test conform that, the difference does not raise any new performance questions.

### 8.0 Discussion of non-clinical test performed

Non-clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The test results demonstrate that the proposed device conforms to the recognized standards ASTM F2100-19, ASTM F1862, ASTM F2101, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.

| ASTM F2100<br>Level | Level 3 | Level 2 | Different note 8 |
|---------------------|---------|---------|------------------|
|---------------------|---------|---------|------------------|

| Performance testing | | | |
|-----------------------------------------------------|--------------------------|----------------------------------|--------|
| Item | Proposed device | Acceptance criteria | Result |
| Fluid Resistance<br>Performance ASTM<br>F1862 | ≥160 mmHg | 29 out of 32 pass at 160<br>mmHg | Pass |
| Particulate Filtration<br>Efficiency ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Bacterial Filtration<br>Efficiency ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure<br>(Delta P) MIL-M-<br>36954C | < 6.0mmH2O/cm² | < 6.0mmH2O/cm² | Pass |
| Flammability 16 CFR<br>1610 | Class 1<br>Non Flammable | Class 1 | Pass |
| Barrier protection level | Level 3 | Level 3 | Pass |

#### Performance testing

#### Biocompatibility testing

| Item | Proposed device | Result |
|---------------|---------------------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Irritation | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
| Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |

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# 9.0 Clinical Test Conclusion

No clinical study is included in this submission.

#### 10.0 Comparison to the predicate device and the conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K201625, Disposable Medical Surgical Mask (rectangular), is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.