(226 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The description states the device is intended to protect from transfer of microorganisms and body fluids, not to treat a disease or condition.
No
The device is a surgical face mask, intended for protection against microorganisms and fluids, not for diagnosing medical conditions.
No
The device description and performance studies clearly indicate a physical, disposable surgical mask made of polypropylene layers, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting against the transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of components designed to analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This mask does not perform any such analysis.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration, fluid resistance, breathability, flammability) and biocompatibility, which are relevant to its function as a barrier device, not a diagnostic one.
In summary, the device is a physical barrier intended for infection control, not a device used to perform tests on biological samples for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient and healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Results:
- Level 3 Fluid Resistance (ASTM F1862): 32 Out of 32 pass at 160 mmHg. Acceptance Criteria: 29 Out of 32 pass at 160 mmHg. Result: Pass.
- Particulate Filtration Efficiency (ASTM F2299): 99.67-99.80%. Acceptance Criteria: ≥ 98%. Result: Pass.
- Bacterial Filtration Efficiency (ASTM F2101): 99.6 - 99.9%. Acceptance Criteria: ≥ 98%. Result: Pass.
- Differential Pressure (ASTM F2100): 4.8-5.0 mmH₂0/cm². Acceptance Criteria:
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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:
- SUBMITTER String King Lacrosse, LLC 19100 S Vermont Ave. Gardena, CA. 90248 USA Tel: +1.508.654.1988 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.
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| Device | Proposed Device -
Surgical Mask - Level 3
& Procedure Mask -
Level 3 (K202607) | Predicate Device -
DemeMASK
(K201479) | Result |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer | StringKing | DemeTECH Corporation | N/A |
| 510K Number | K202607 | K201479 | N/A |
| Product Common
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
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. | 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. | Identical |
| Model | 3 Ply, Ear Loops, Flat-Pleated
Style | 3 Ply, Ear Loops or Tie-On | No tie-on
option for
subject device |
| Materials | | | |
| Outer Facing
Layer | Spun-Bond Polypropylene
(same material as inner layer) | Spunbond Polypropylene | Same |
| Middle Layer | Melt-blown Polypropylene | Melt Blown Polypropylene
Filter | Same |
| Inner Facing Layer | Spun-Bond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | LDPE cover and galvanized wire
core | Single Galvanize Wire, Coated
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
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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 -
Surgical Mask - Level 3 &
Procedure Mask - Level 3 | Predicate Device -
DemeMASK (K201479) | Acceptance Criteria | Subject
Device
Result |
|----------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------|-------------------------------|-----------------------------|
| Level 3 Fluid
Resistance
Performance
ASTM F1862 | 32 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at
160 mm Hg | 29 Out of 32 pass at 160 mmHg | Pass |
| Particulate
Filtration
Efficiency
ASTM F2299 | 99.67-99.80% | ≥99% | ≥ 98% | Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | 99.6 - 99.9% | ≥99% | ≥ 98% | Pass |
| Differential
Pressure
ASTM F2100 | 4.8-5.0 mmH₂0/cm² | Avg. 3.6 mmH₂0/cm² |