(135 days)
Not Found
No
The device is a simple surgical face mask and the summary does not mention any AI/ML components or capabilities.
No.
The device description and intended use clearly state that it is a surgical face mask designed to protect against microorganisms and body fluids, not to treat or cure a disease or condition.
No
The device is a surgical face mask designed to protect against the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly outlines a physical, multi-layered face mask made of nonwoven polypropylene and meltblown fiber, with performance testing focused on physical properties like filtration, fluid resistance, and flammability. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops). There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, fluid resistance, breathability, and biocompatibility. These are relevant to a barrier device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 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 device description for the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks – Premarket Notification [510K]] Submissions issued on March 5, 2004. The Premier Guard Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile.
The proposed device is not made from natural rubber latex.
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
Not Found
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)
Testing was conducted to demonstrate substantial equivalence of the Premier Guard USA 3 Laver Ear Loop ASTM Level 3 Surgical Face Mask to the predicate, Wuhan Dymex Healthcare Co. Ltd. Surgical Face Mask K182515.
Premier Guard USA followed the "Guidance for Industry and FDA Staff Surgical Masks -Premarket Notification [510(k)] Submissions Document [Issued on: March 5, 2004 and a correction posted on July 14, 2004]".
Non-Clinical Performance Testing: The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
- Fluid Resistance per ASTM F1862: Pass at 160 mmHg. Acceptance Criteria: 29 out of 32 pass at 160 mmHg. Result: Pass.
- Particulate Filtration Efficiency ASTM F2299: ≥98%. Acceptance Criteria: ≥98%. Result: Pass.
- Bacterial Filtration Efficiency ASTM F2101: ≥98%. Acceptance Criteria: ≥98%. Result: Pass.
- Differential Pressure (Delta P) EN 14683:
§ 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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 21, 2021
Premier Guard USA LLC % Valerie Followell President-Owner Followell Compliance Consultants LLC 8049 Tripp Ave Skokie, Illinois 60076
Re: K202595
Trade/Device Name: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 19, 2020 Received: December 21, 2020
Dear Valerie Followell:
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.
1
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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known) K202595
Device Name
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
Indications for Use (Describe)
The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 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)
| For Activities Under EPA NPDES General Permit | |
|---|---|
| For Other Activities Under EPA NPDES General Permit |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K202595 510(k) SUMMARY
Submission Correspondent
Contact Person: Valerie Followell Followell Compliance Consultants LLC 8049 Tripp Ave. Skokie, IL 60076 Phone: 847-400-6187 Email: valeriefollowell@outlook.com
Premier Guard USA LLC 460 Briarwood Drive, Suite 400 Jackson, MS 39206 Phone: 310-717-7542 Email: howard.sherman@premierguardusa.com
Date Prepared
January 7, 2021
Device Information
Trade Name: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask Common Name: Surgical Mask Classification Name: Surgical Mask Product Code: FXX Classification Panel: General Hospital Regulatory Class: Class II Regulation Number: 21 CFR 878.4040
Predicate Device Information
Wuhan Dymex Healthcare Co. Ltd. Surgical Face Mask K182515
Device Description
The device description for the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks – Premarket Notification [510K]] Submissions issued on March 5, 2004. The Premier Guard Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven
4
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask 510(k) Submission
polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.
The proposed device is not made from natural rubber latex.
Indications for Use
The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 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 fluid. This is a single use, disposable device, provided non-sterile
Summary of Technological Characteristics
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Premier Guard USA 3 Layer Ear
Loop ASTM Level 3 Surgical
Face Mask | Wuhan Dymex Healthcare Co.
Ltd. Surgical Face Mask | Different |
| 510(k) Reference | K202595 | K182515 | Different |
| Product Owner | Premier Guard USA LLC | Wuhan Dymex Healthcare Co.,
Ltd. | Different |
| Product Code | FXX | FXX | Same |
| Indications for Use | The Premier Guard USA 3
Layer Ear Loop ASTM Level 3
Surgical Face Masks are
intended to be worn to
protect both 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. | The Disposable Surgical Face
Masks are intended to be
worn to protect both 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 |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Mask Style | Flat Pleated, Ear Loops, 3
Layers | Flat Pleated, Ear Loops, 3
Layers | Same |
| Mask Color | Blue | Yellow | Different |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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| Materials | |||
|---|---|---|---|
| Nose Piece (material) | Polyethylene laminated soft annealed carbon steel wire | Malleable aluminum wire | Different |
| Ear Loops (material) | Nylon and Spandex | Spandex | Similar |
| Outer Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle Layer | Melt blown fiber | Melt blown polypropylene filter | Similar |
| Inner Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Dimensions - Width | 175mm | 17.5cm±1cm | Same |
| Dimensions - Length | 95mm | 9.5cm±1cm | Same |
| ASTM F2100 Level | Level 3 | Level 2 | Different |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic | Same |
| Sensitization | Under the conditions of the study, the device is non-sensitizing | Under the conditions of the study, the device is non-sensitizing | Same |
| Irritation | Under the conditions of the study, the device is non-irritating | Under the conditions of the study, the device is non-irritating | Same |
| Prescription vs. OTC | OTC | OTC | Same |
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs. Non-Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |
Discussion of Similarities and Differences
The differences in material composition and the colorant do not raise new questions of safety or effectiveness as biocompatibility testing was performed on the final finished device and the results demonstrate that the subject device is non-cytotoxic, nonsensitizing and non-irritating.
When tested for fluid resistance per ASTM F1862 at 160 mmHg the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask met the requirements for a level 3 face mask. The predicate device was tested at 120 mmHg, therefore, meeting the requirements for a level 2 face mask. The Premier Guard USA 3 Layer Ear Loop ASTM
6
Level 3 Surgical Face Mask provided a higher level of fluid resistance as compared to the predicate device and when tested per ASTM F1862.
Summary of Testing and Supporting Information
Testing was conducted to demonstrate substantial equivalence of the Premier Guard USA 3 Laver Ear Loop ASTM Level 3 Surgical Face Mask to the predicate, Wuhan Dymex Healthcare Co. Ltd. Surgical Face Mask K182515.
Premier Guard USA followed the "Guidance for Industry and FDA Staff Surgical Masks -Premarket Notification [510(k)] Submissions Document [Issued on: March 5, 2004 and a correction posted on July 14, 2004]".
A summary of testing is presented below with more information provided in the applicable sections.
Non-Clinical Performance Testing
The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
- Fluid Resistance per ASTM F1862
- Particulate Filtration Efficiency per ASTM F2299
- Bacterial Filtration Efficiency per ASTM F2101
- Differential Pressure (Delta P) per EN 14683
- Flammability per 16 CFR 1610
| Test | Subject Device | Acceptance Criteria | Result | |
|---|---|---|---|---|
| Fluid Resistance | ||||
| Performance ASTM | ||||
| F1862 | Pass at 160 mmHg | 29 out of 32 pass at 160 | ||
| mmHg | Pass | |||
| Particulate Filtration | ||||
| Efficiency ASTM F2299 | ≥98% | ≥98% | Pass | |
| Bacterial Filtration | ||||
| Efficiency ASTM F2101 | ≥98% | ≥98% | ||
| Differential Pressure | ||||
| (Delta P) EN 14683 |