Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs

K202607 · String King Lacrosse, LLC · FXX · Apr 23, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202607
• Device Name: Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs
• Applicant: String King Lacrosse, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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 provided non-sterile.

Device Story

3-ply disposable surgical/procedure mask; non-sterile; single-use. Constructed with inner/outer spun-bond polypropylene layers and middle melt-blown polypropylene filter layer. Features LDPE-covered galvanized wire nose piece and nylon/spandex/polyester ear loops. Used in clinical settings by healthcare personnel or patients to provide barrier protection against microorganisms, body fluids, and particulates. Operates as a passive physical barrier; no electronic or active components. Performance meets ASTM F2100 Level 3 standards for fluid resistance, filtration efficiency, and breathability. Benefits patient and staff by reducing cross-contamination risk during medical procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by benchtop performance testing including fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure (ASTM F2100), and flammability (16 CFR 1610). Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10 confirmed the device is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

3-ply non-woven polypropylene construction (spun-bond outer/inner, melt-blown middle). Nose piece: LDPE-covered galvanized wire. Ear loops: nylon, spandex, polyester. Dimensions: 9.5cm x 17.5cm. Passive device; no energy source, software, or connectivity. Non-sterile.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings.

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

• DemeMASK (K201479)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

April 23, 2021

String King Lacrosse, LLC % Thomas Frasca President 19100 S Vermont Ave. Gardena, CA, 90248 USA

Re: K202607

Trade/Device Name: Surgical Mask - Level 3 & Procedure Mask - Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 9, 2020 Received: September 9, 2020

Dear Thomas Frasca:

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

{1}------------------------------------------------

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 Ryan Ortega, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K202607

Device Name Surgical Mask - Level 3 & Procedure Mask - Level 3

Indications for Use (Describe)

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 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) SUMMARY - K202607

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

1. SUBMITTER String King Lacrosse, LLC 19100 S Vermont Ave. Gardena, CA. 90248 USA Tel: [phone] Fax: N/A Contact Person: Thomas Frasca

April 22, 2021

| II. DEVICE | |
|------------------------------|----------------------------------------------------|
| Name of Device: | Surgical Mask – Level 3 & Procedure Mask – Level 3 |
| Classification Name: | Surgical Mask |
| Regulation: | 21 CFR § 878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FXX |

PREDICATE DEVICE |||.

Date Prepared:

| Predicate Manufacturer: | DemeTECH Corporation |
|-------------------------|----------------------|
| Predicate Trade Name: | DemeMASK |
| Predicate 510(k): | K201479 |

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The 3-ply surgical mask is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.

#### V. INDICATIONS FOR USE

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 provided non-sterile.

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

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence in Table 1 below.

{4}------------------------------------------------

| Device | Proposed Device -<br>Surgical Mask - Level 3<br>& Procedure Mask -<br>Level 3 (K202607) | Predicate Device -<br>DemeMASK<br>(K201479) | Result |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer | StringKing | DemeTECH Corporation | N/A |
| 510K Number | K202607 | K201479 | N/A |
| Product Common<br>Name | SURGICAL FACE MASK | SURGICAL FACE MASK | Identical |
| Product Code | FXX | FXX | Identical |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Identical |
| Intended Use | The disposable surgical face<br>masks are intended to be<br>worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material.<br>These face masks are<br>intended for use in infection<br>control practices to reduce<br>the potential exposure to<br>blood and body fluids. This<br>is a single-use, disposable<br>device provided non-sterile. | The Disposable Surgical<br>Face Masks are intended to<br>be worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material.<br>These face masks are<br>intended for use in infection<br>control practices to reduce<br>the potential exposure to<br>blood and body fluids. This<br>is a single use, disposable<br>device provided non-sterile. | Identical |
| Model | 3 Ply, Ear Loops, Flat-Pleated<br>Style | 3 Ply, Ear Loops or Tie-On | No tie-on<br>option for<br>subject device |
| Materials | | | |
| Outer Facing<br>Layer | Spun-Bond Polypropylene<br>(same material as inner layer) | Spunbond Polypropylene | Same |
| Middle Layer | Melt-blown Polypropylene | Melt Blown Polypropylene<br>Filter | Same |
| Inner Facing Layer | Spun-Bond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | LDPE cover and galvanized wire<br>core | Single Galvanize Wire, Coated<br>By PE | Same |
| Ear Loops | Nylon, Spandex, Polyester | not made with natural rubber latex | Same |
| Color | Blue | White | Different, performance supported by biocompatibility and performance test data |
| Dimension (Width) | 9.5 cm ± 0.5 cm | 9.5 cm ± 1.0 cm | Similar |
| Dimension (Length) | 17.5 cm ± 1 cm | 17.5 cm ± 1.0 cm | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 3 | Level 3 | Same, see Table 2 |
| Biocompatibility ISO 10993-5 and ISO 10993-10 | Non-cytotoxic, nonsensitizing, and nonirritating | Non-cytotoxic, nonsensitizing, and nonirritating | Same, see Table 3 |

## Table 1 – Comparison of Technological Characteristics

{5}------------------------------------------------

{6}------------------------------------------------

## VII. NON-CLINICAL DATA

The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2 along with the acceptance criteria and the predicate device's reported results.

| Item | Proposed Device -<br>Surgical Mask - Level 3 &<br>Procedure Mask - Level 3 | Predicate Device -<br>DemeMASK (K201479) | Acceptance Criteria | Subject<br>Device<br>Result |
|----------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------|-------------------------------|-----------------------------|
| Level 3 Fluid<br>Resistance<br>Performance<br>ASTM F1862 | 32 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at<br>160 mm Hg | 29 Out of 32 pass at 160 mmHg | Pass |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | 99.67-99.80% | ≥99% | ≥ 98% | Pass |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | 99.6 - 99.9% | ≥99% | ≥ 98% | Pass |
| Differential<br>Pressure<br>ASTM F2100 | 4.8-5.0 mmH₂0/cm² | Avg. 3.6 mmH₂0/cm² | < 6.0 mmH₂0/cm² | Pass |
| Class 1<br>Flammability<br>16 CFR 1610 | Did not ignite or Ignited but<br>Extinguished | Class 1 | < 3.5 second burn time | Pass |

### Table 2 - Benchtop Performance Testing

## Sterilization & Shelf-life Testing

Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)

### Biocompatibility Testing

Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.

{7}------------------------------------------------

| Standards | Proposed Device -<br>Surgical Mask - Level 3 &<br>Procedure Mask - Level 3 | Predicate Device -<br>DemeMASK (K201479) | Result |
|-----------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------|--------|
| Cytotoxicity -<br>ISO 10993-5 | Under the conditions of the<br>study the device is non-<br>cytotoxic | Under the conditions of the<br>study the device is non-<br>cytotoxic | Pass |
| Skin<br>Sensitization -<br>ISO 10993-10 | Under the conditions of the<br>study the device is non-<br>sensitizing | Under the conditions of the<br>study the device is non-<br>sensitizing | Pass |
| Skin Irritation -<br>ISO 10993-10 | Under the conditions of the<br>study the device is non-<br>irritating | Under the conditions of the<br>study the device is non-<br>irritating | Pass |

### Table 3 - Biocompatibility Testing

### Software Verification and Validation Testing

Not Applicable (Passive Device)

#### Electrical safety and electromagnetic compatibility (EMC)

Not Applicable (Passive Device)

#### Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

#### VIII. CONCLUSIONS

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device (K201479), manufactured by DemeTECH Corporation.