Surgical Mask

K202640 · Jiangsu Medpure Biological Technology Co., Ltd. · FXX · Jan 22, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202640
• Device Name: Surgical Mask
• Applicant: Jiangsu Medpure Biological Technology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jan 22, 2021
• 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. This face 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(s), provided non-sterile.

Device Story

Surgical mask; blue, flat-pleated, 3-layer design; worn over mouth and nose via elastic ear loops; includes integrated nose piece for fit. Outer/inner layers: PP spun-bond non-woven; middle layer: melt-blown non-woven. Ear loops: polyester/polyurethane; nose piece: polyethylene/metal wire. Single-use, disposable, non-sterile. Used in clinical settings for infection control; reduces exposure to blood, body fluids, and particulates. Provides physical barrier; no active components.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19 (Level 2), including fluid resistance (120 mmHg), particulate filtration efficiency (≥99.73%), bacterial filtration efficiency (≥99.07%), and differential pressure (≤4.7 mmH2O/cm²). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Flammability tested per 16 CFR 1610 (Class 1).

Technological Characteristics

3-layer non-woven construction (PP spun-bond/melt-blown/PP spun-bond). Nose piece: polyethylene/metal wire. Ear loops: polyester/polyurethane. Dimensions: 17.5 cm x 9.5 cm. ASTM F2100 Level 2 performance. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, 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

• Disposable Surgical Face Mask (K153496)

Submission Summary (Full Text)

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January 22, 2021

Jiangsu Medpure Biological Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K202640

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 11, 2020 Received: September 11, 2020

Dear Ray 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 and Part 809); 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 (OS) 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, M.S. 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) K202640

Device Name Surgical Mask

#### 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. This face 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(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

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202640

- 1. Date of Preparation: 2021/01/14
- 2. Sponsor Identification

# Jiangsu Medpure Biological Technology Co., Ltd.

No. 1 Beiyang Road, Hexi Village, Zouqu Town, 213144 ChangZhou City, Jiangsu Province, P.R.China

Contact Person: Jianwen Fei Position: Management Representative Tel: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

# Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Surgical Mask Common Name: SurgicalFace Mask

### Regulatory Information

Classification Name: Surgical Face Mask Classification: II Product Code: FXX Regulation Number: 21CFR 878.4040 Review Panel: Surgical Apparel

## Indication for use Statement:

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. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a s ingle-use, dis posable device(s), provided non-sterile.

## Device Description

The Surgical Mask is Blue color, and Flat Pleated type mask, utilizing Ear Loops ' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric. The Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. Theelastic ear loops are made with Polyester fiber and Polyurethane. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of Polyethylene and Metal Wire. The mask is sold non-sterile and are intended to be single-use, dis posable devices and the colorant used for mask is TiO2 + Phthalocyanine Blue BGS + Pigment Violet23.

- న. Identification of Predicate Device(s)
Predicate Device K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., ltd.

#### Non-Clinical Test Conclusion 6.

Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

> ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro

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Cytotoxicity

- > ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- > A.STM F2100-19, Standard Specification For Performance Of Materials Used In Medical Face Masks.
- A A.STM F1862-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- > MIL-M-36945C, Method 1 Military Specifications: Surgical Mask disposable;
- > ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
- > ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latexspheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles ;
- > Bench Testing for the performance of Dimensions.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

- 8. Summary of Technological Characteristics

| Table 1 General Comparison | | | | |
|----------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ITEM | | Proposed Device K202640 | Predicate Device K153496 | Remark |
| 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. This face 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(s), provided non-sterile. | The Disposable 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 is a single use, disposable device(s), provided non-sterile. | SAME |
| Basic Design | | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | SAME |
| Materials | Outer Facing Layer | Spun-bond non-woven fabric | Spun-bond polypropylene | Similar |
| | Middle Layer | Melt blown non-woven fabric | Melt blown polypropylene filter | |
| | Inner Facing Layer | Spun-bond non-woven fabric | Spun-bond polypropylene | |
| | Nose Piece | Polyethylene and Metal Wire | Malleable aluminum wire | |
| | Ear Loops | Polyester fiber and Polyurethane | Polyester | |
| Color | | Blue | | SAME |
| Dimension (Length) | | 17.5 cm +/- 5% | 17.5 cm +/- 1cm | Similar |

# Table 1 General Comparison

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| Dimension (Width) | 9.5 cm +/- 5% | 9.5 cm +/- 1cm | |
|-------------------|---------------|----------------|------|
| OTC use | Yes | Yes | SAME |
| Single Use | Yes | Yes | SAME |
| Sterile | No | No | SAME |
| ASTM F2100 Level | Level 2 | Level 2 | SAME |

### Table 2 Performance Characteristic Comparison

| ITEM | Proposed Device | Predicate Device | ASTM F2100<br>Requirements for<br>Level 2 Classification | Remark |
|-------------------------------------------|-----------------|------------------|----------------------------------------------------------|--------|
| | K202640 | K153496 | | |
| Fluid Resistance<br>Performance ASTM | 120 mmHg | 120 mmHg | 120 mmHg | SAME |
| Particulate Filtration<br>Efficiency ASTM | ≥99.73% | 98.46% | ≥ 98% | |
| Bacterial Filtration<br>Efficiency ASTM | ≥99.07% | 98.7% | ≥ 98% | |
| Differential Pressure<br>(Delta P) | ≤4.7 mmH2O/cm² | 4.2 mmH2O/cm² | < 6.0 mmH2O/cm² | |
| Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | SAME |

# Table 3 Biocompatibility Comparison

| ITEM | Proposed Device K202640 | Predicate Device K153496 | Remark |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity | Comply with ISO 10993-5<br>Under the conditions of the study, the<br>proposed device extract was determined to<br>be non-cytotoxic | Comply with ISO 10993-5<br>Under the conditions of the study, the<br>proposed device extract was determined to<br>be non-cytotoxic | SAME |
| Irritation | Comply with ISO 10993-10<br>Under the conditions of the study, the<br>proposed device extract was determined to<br>be non-irritating. | Comply with ISO 10993-10<br>Under the conditions of the study, the<br>proposed device extract was determined to<br>be non-irritating | SAME |
| Sensitization | Comply with ISO 10993-10<br>Under the conditions of the study, the<br>proposed device extract was determined to<br>be non-sensitizing. | Comply with ISO 10993-10<br>Under the conditions of the study, the<br>proposed device extract was determined to<br>be non-sensitizing | SAME |

#### 9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202640, the Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under k153496.