Standard Procedure Mask, Standard Surgical Mask

K202605 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · FXX · Feb 10, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202605
• Device Name: Standard Procedure Mask, Standard Surgical Mask
• Applicant: Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Feb 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The device 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, provided non-sterile.

Device Story

Standard Procedure Mask and Standard Surgical Mask are three-layer, flat-pleated, single-use, disposable face masks. The Procedure Mask uses ear-loops; the Surgical Mask uses ties. Both feature a plastic nose clip and are constructed from spunbonded and melt-blown nonwoven fabrics. Used in clinical settings by healthcare personnel and patients to provide a physical barrier against microorganisms, body fluids, and particulates. The device is worn over the nose and mouth. It functions as a passive barrier to reduce cross-contamination and exposure to blood/body fluids. No electronic components or active processing involved.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F1862 (synthetic blood penetration at 120 mmHg), ASTM F2101 (BFE 98.61%), ASTM F2299 (PFE 98.58%), EN 14683 (differential pressure 4.41 mm H2O/cm²), and 16 CFR 1610 (flammability Class I). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation).

Technological Characteristics

Three-layer flat-pleated mask. Materials: Spunbonded nonwoven, melt-blown nonwoven, polyester/spandex ear straps, plastic nose clip. Dimensions: 175x95mm. Non-sterile. Performance meets ASTM F2100 Level 2 requirements. No energy source or software.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material during 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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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 10, 2021

Jiangsu Medplus Non-woven Manufacturer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K202605

Trade/Device Name: Standard Procedure Mask, Standard Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 20, 2020 Received: November 19, 2020

Dear Diana Hong:

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, 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)

K202605

#### Device Name

Standard Procedure Mask; Standard Surgical Mask

#### Indications for Use (Describe)

The device 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, 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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# K202605

# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

- 1. Date of Preparation: 01/29/2021
- 2. Sponsor Identification

## Jiangsu Medplus Non-woven Manufacturer Co., Ltd.

No.217 East Wencheng Road, Economic Development Zone, Siyang, Jiangsu, 223700, China

Contact Person: Shuying An Position: Product Manager Tel: [phone] Fax: [phone] Email: [e-mail]

3. Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

## Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

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

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#### 4. Identification of Proposed Devices

Trade Name: Standard Procedure Mask; Standard Surgical Mask Common Name: Surgical Face Mask

Regulatory Information Classification Name: mask, surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital;

Indication for use:

The device 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, provided non-sterile.

Device Description:

The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.

5. Identification of Predicate Device

510(k) Number: K153496 Product Name: Disposable Surgical Face Mask

6. Summary of Non-Clinical Testing

The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.

| Name of the Test<br>Methodology / Standard | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|
| Resistance to Penetration<br>by Synthetic blood<br>ASTM F1862/F1862M-17<br>Standard Test Method for | The test was performed in accordance with ASTM F1862-17 Standard Test Method for Resistance of | No penetration at 120 mmHg | Pass at 120mmHg |
| Resistance of Medical | Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) to evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids | | |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101-2019<br>Standard Test Method for<br>Evaluating the Bacterial<br>Filtration Efficiency (BFE)<br>of Medical Face Mask<br>Materials, Using a<br>Biological Aerosol of<br>Staphylococcus aureus | The test was performed in accordance with ASTM<br>F2101-19 Standard Test<br>Method for Evaluating the<br>Bacterial Filtration<br>Efficiency (BFE) of Medical<br>Face Mask Materials, using a<br>Biological Aerosol of<br>Staphylococcus aureus to<br>determine the bacterial<br>filtration efficiency (BFE) of<br>the test article. | $\ge98%$ | Average 98.61% |
| Particulate Filtration<br>Efficiency<br>ASTM F2299/F2299M-03<br>(2017) Standard Test<br>Method for Determining<br>the Initial Efficiency of<br>Material Used in medical<br>Face Masks to Penetration<br>by Particulates using Latex<br>Spheres | The test was performed in accordance with ASTM<br>F2299-03 (Reapproved<br>2017) Standard Test Method<br>for Determining the Initial<br>Efficiency of Materials Used<br>in Medical Face Masks to<br>Penetration by Particulates<br>Using Latex Spheres, to<br>determine the Particle<br>Filtration Efficiency. | $\ge98%$ | Average 98.58% |
| Differential Pressure<br>EN 14683:2019 Medical<br>face masks- Requirements<br>and test methods | The test was performed in accordance with EN<br>14683:2019 Medical face<br>masks-Requirements and test<br>methods, to determine the<br>differential pressure. | $<6.0 mm H2O/cm2$ | Average 4.41 mm<br>H2O/cm² |
| Flammability | The test was performed in | Class I | Class I |
| the Flammability of | 1610 STANDARD FOR | | |
| Clothing Textiles | THE FLAMMABILITY OF | | |
| Corrections | CLOTHING TEXTILES to | | |
| | evaluate the flammability of | | |
| | the test sample. | | |

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- 7. Clinical Test Conclusion
No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| | Proposed Devices | Predicate Device | Remark |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| ITEM | K202605 | K153496 | |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | The device 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, 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 |
| Mask style | Flat pleated | Flat pleated | Same |
| Mask color | Blue | Blue | Same |
| Design Feature | Ear-loop or tie-on | Ear-loop or tie-on | Same |
| Dimension (mm) | 175×95 | 175×95 | Same |
| Level | Level 2 | Level 2 | Same |
| Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate efficiency level | ≥98% | ≥98% | Same |
| Bacterial filtration level | ≥98% | ≥98% | Same |
| Differential pressure | <6.0 mm H2O/cm² | 4.2 mmH20/cm² | Different 1 |

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| Flammability | Class 1 | Class 1 | Same |
|----------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------|
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Single use | Single use | Single use | Same |
| Ear strap | Polyester and spandex and<br>Spunbonded nonwoven | Polyester and Spun-bond<br>polypropylene | Different 2 |
| Nose clip | Plastic | Malleable aluminum wire | Different 2 |
| Mask body | Spunbonded nonwoven and Melt-<br>blown nonwoven fabric | Spun-bond polypropylene and<br>Melt blown polypropylene filter | Different 2 |
| Cytotoxicity | ISO 10993-5;<br>Under the conditions of the study,<br>the proposed device extract was<br>determined to be non - cytotoxic. | ISO 10993-5;<br>Under the conditions of the study, the proposed device<br>extract was determined to be<br>non - cytotoxic. | Same |
| Sensitization | ISO 10993-10;<br>Under the conditions of the study,<br>the proposed device extract was<br>determined to be non-sensitizing. | ISO 10993-10;<br>Under the conditions of the study, the proposed device<br>extract was determined to be<br>non-sensitizing. | Same |
| Irritation | ISO 10993-10;<br>Under the conditions of the study,<br>the proposed device extract was<br>determined to be non-irritating. | ISO 10993-10;<br>Under the conditions of the study, the proposed device<br>extract was determined to be<br>non-irritating. | Same |
| Sterility | Non-sterile | Non-sterile | Same |

## Different 1- Differential pressure

The test result for different pressure for the proposed device is different from predicate devices. The differential pressure test standard has been updated to EN14683:2019, Annex C in ASTM F2100:2019. The differential pressure test of the proposed device was conducted according to EN14683:2019, Annex C, and the test result demonstrate that the differential pressure of the proposed device meet the requirements of level 2 specified in ASTM F2100:2019. Thus, this difference does not affect substantially equivalence between the proposed device and predicate devices.

### Different 2- Patient Contacting Material

The patient contact material for the propose device is different from predicate devices. However, biocompatibility tests have been conducted on the propose device and the test result does not show any adverse effect. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate devices.

- 9. Conclusion

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The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K153496.