3 Ply Medical Grade Single Use Procedural Disposable Face Mask

K220637 · Kdi Med Supply · FXX · Mar 25, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220637
• Device Name: 3 Ply Medical Grade Single Use Procedural Disposable Face Mask
• Applicant: Kdi Med Supply
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This is a single use, disposable device provided non-sterile.

Device Story

Single-use, non-sterile, flat-pleated procedural face mask; worn by patients and healthcare providers. Constructed of three layers: outer and inner spun-bond polypropylene, middle melt-blown polypropylene filter. Features malleable plastic-coated steel nose piece and polyester/spandex ear loops. Used in clinical settings for infection control to provide fluid resistance and filtration of microorganisms and particulates. Protects users by acting as a physical barrier against blood, bodily fluids, and airborne particles. No natural rubber latex components.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F2100, ASTM F1862 (fluid resistance at 120 mmHg), ASTM F2299 (particulate filtration >99.99%), ASTM F2101 (bacterial filtration >99.9%), and 16 CFR 1610 (flammability Class 1). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Materials: Spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter), plastic-coated steel nose piece, polyester/spandex ear loops. ASTM F2100 Level 2 compliant. Dimensions: 9.5cm x 17cm. Non-sterile. Single-use. No natural rubber latex.

Indications for Use

Indicated for use by patients and healthcare providers to protect against transfer of microorganisms, body fluids, and particulate material, and to reduce exposure to blood and bodily 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

• Single-Use Surgical Mask with Ear Loop (K201691)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

March 25, 2022

KDI Med Supply % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K220637

Trade/Device Name: 3 Ply Medical Grade Single Use Procedural Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: March 3, 2022 Received: March 4, 2022

Dear Prithul Bom:

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.

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220637

### Device Name

3 Ply Medical Grade Single Use Procedural Disposable Face Mask

Indications for Use (Describe)

The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily 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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Image /page/3/Picture/0 description: The image shows the logo for KDI Med Supply, which features a blue square, a gray square, and a dark blue square with a white plus sign in the middle. To the right of the squares is the text "KDI MED SUPPLY" in gray, blue, and black. To the right of the logo is a blue face mask with white ear loops and a "Made in USA" logo.

# 510(k) SUMMARY - K220637

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

Type of Submission: Traditional

Date Prepared: 3/24/2022

Device Type: Surgical Mask

#### l. SUBMITTER

KDI Med Supply 206 Lynn St. Fremont, OH 43420 USA Phone: [phone] or [phone] Fax: N/A

Contact Person: Yolanda Davis Email: [e-mail]

#### ll. SUBJECT DEVICE

| Device/Trade Name: | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask |
|----------------------|----------------------------------------------------------------|
| Classification Name: | Mask, Surgical |
| Regulation: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Common Name: | Level 2 Medical Grade Mask |
| Device Panel: | General Hospital |
| Product Code: | FXX |

#### lll. PREDICATE DEVICE

Manufacturer: Qiqihar Hengxin Medical Supplies, Ltd. Trade/Device Name: Single-Use Surgical Mask with Ear Loop (K201691)

No reference devices were used in this submission.

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#### IV. DEVICE DESCRIPTION

The KDI Med Supply surgical face mask is with blue outer color layer and white inner and middle layer. Subject device is a flat pleated type mask, utilizing ear loop way for wearing, and it has a nose piece designed for fitting the face mask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner layer (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The masks contains a malleable nose piece to provide a firm fit over the nose and to secure the mask over the users mouth and face. The mask has level II fluid resistance under ASTM F2100. The mask is a single use, provided nonsterile. This product contains no components made with natural rubber latex.

#### V. INDICATIONS FOR USE

The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This is a single use, disposable device provided nonsterile.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following characteristics were compared between the subject device and the predicate device in Table 1 below

| Feature | Subject Device:<br>3 Ply Medical Grade<br>Single Use Procedural<br>Disposable Face Mask<br>(K220637) | Predicate Device:<br>Single-Use Surgical<br>Face Mask with Ear<br>Loop (K201691) | Result |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indications for Use | The<br>Disposable<br>Surgical Face Masks<br>are intended to be<br>worn to protect both<br>the patient and<br>healthcare provider<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended<br>for use in infection<br>control practices to<br>reduce the potential<br>exposure to blood and<br>bodily fluids. | The single-use<br>surgical mask with<br>ear loop is intended<br>to be worn to protect<br>both the patient and<br>healthcare personnel<br>from the transfer of<br>microorganisms,<br>body fluids, and<br>particulate material.<br>The Single Use<br>Surgical Mask with<br>ear loop is intended<br>for use in infection<br>control practices to<br>reduce the potential | Same |

## Table 1 – Comparison of Technological Characteristics

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| | single use, disposable<br>device provided non-<br>sterile. | exposure to blood<br>and bodily fluids. This<br>is a single-use, | |
|-----------------------------|------------------------------------------------------------|------------------------------------------------------------------|-----------|
| | | disposable device(s),<br>provided non-sterile. | |
| <b>Materials</b> | | | |
| Inner Facing Layer | Spun-Bond<br>Polypropylene | Spun-Bond<br>Polypropylene | SAME |
| Middle Layer | Melt Blown<br>polypropylene | Melt Blown<br>polypropylene | SAME |
| Outer Facing Layer | Spun-bond<br>polypropylene | Spun-Bond<br>Polypropylene | SAME |
| Nose Piece | Wire, malleable<br>nosepiece, plastic-<br>coated steel | Wire, malleable<br>aluminum nosepiece | Different |
| Ear Loop | Polyester and<br>spandex materials | polyester | SAME |
| Color | Blue Outer Layer | Blue Outer Layer | SAME |
| Mask Style | Flat pleated, ear loop | Flat pleated, ear loop | SAME |
| Dimension (Width)<br>Adult | $9.5 cm +/-0.5cm$ | $9 cm +/-1cm$ | SIMILAR |
| Dimension (Length)<br>Adult | $17 cm +/-0.5cm$ | $18 cm +/- 1 cm$ | SIMILAR |
| Single Use | Yes | Yes | SAME |
| OTC Use | Yes | Yes | SAME |
| Sterility | Non-Sterile | Non-Sterile | SAME |

#### VII. PERFORMANCE DATA

# Table 2 – Benchtop Performance Testing

| Item | Subject Device:<br>3 Ply Medical Grade<br>Single Use Procedural<br>Disposable Face Mask<br>(K220637) | Predicate Device:<br>Single-Use Surgical<br>Face Mask with Ear<br>Loop (K201691) | Result |
|-------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------|
| ASTM F2100 Level | II | II | PASS |
| Fluid resistance<br>(ASTM F1862) | 32 out of 32 pass at<br>120 mmHG (16.0 kPa) | 31 out of 32 pass at<br>120 mmHg (16.0 kPa) | PASS |
| Particulate<br>Filtration (ASTM<br>F2299) | >99.99% | > 99% | PASS |
| Bacterial Filtration<br>(ASTM F2101) | >99.9% | > 99% | PASS |

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| Differential<br>Pressure (Delta-P)<br>(ASTM F2100) | 8 Liters per minute<br>(L/min) < 6.0<br>mmH20/cm2 | < 5.0 mmH20/cm2 | PASS |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------|
| Biocompatibility<br>ISO 10993 | Irritation (ISO 10993-<br>10), Sensitization (ISO<br>10993-10), Cytotoxicity<br>(ISO 10993-5) | Irritation (ISO 10993-<br>10), Sensitization<br>(ISO 10993-10),<br>Cytotoxicity (ISO<br>10993-5) | PASS |
| Flammability | Class 1 | Class 1 | PASS |

## Summary of Non-Clinical Performance Testing

- The following standards have been used to evaluate the KDI Med Supply's 3 Ply Medical Table 3: Grade Single Use Procedural Disposable Face Mask

| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical Face Masks |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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) |
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| EN 14683 | 2019 Standard Test Method for Differential Pressure 16 CFR Part 1610 Standard for Flammability |
| ISO 10993-1 | 1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5 | 5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices |
| ISO-10993-10 | 10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |

- Table 4: The following performance data has been provided from 3 nonconsecutive lots to demonstrate that the subject device meets the criteria of the standards.

| Test Methodology,<br>Standard | Purpose | Acceptance Criteria | Results |
|-------------------------------|----------------------------------------------------|---------------------|-----------|
| ASTM F1862 | Resistance to<br>Penetration by<br>synthetic blood | 120 mm Hg | 120 mm Hg |
| ASTM F2299 | Particulate filtration<br>efficiency | >98% | > 99.99% |
| ASTM F2101 | Bacterial Filtration | >98% | >99.99% |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |

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| ASTM F2100 | Differential Pressure<br>(Delta-P) | < 6.0 mm H20/cm2 |
|------------------|------------------------------------|------------------|
| < 6.0 mm H20/cm2 | | |

#### VIII. CONCLUSION

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, and effective, and performs well as or better than the legally marketed predicate device.