(356 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard medical mask, with no mention of AI or ML.
No.
The device is described as an "Earloop Mask and Tie-On Mask" intended for use by healthcare workers to protect against the transfer of microorganisms, bodily fluids, and airborne particles, which is a protective barrier, not a therapeutic device.
No
Explanation: The device is an earloop mask and tie-on mask, which is a protective barrier, not a diagnostic device used to identify or analyze diseases or conditions.
No
The device description clearly outlines a physical mask made of various materials like polypropylene and aluminum, with specific dimensions and physical components like earloops or ties. There is no mention of software.
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 mask is for "protect[ing] both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles." This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of a mask designed for filtration and barrier protection. It does not describe any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on properties relevant to a barrier device, such as fluid resistance, filtration efficiency (bacterial and particulate), breathability (Delta P), flammability, and biocompatibility. These are not diagnostic performance metrics.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing any form of diagnostic result.
In summary, the device is a personal protective equipment (PPE) designed to prevent the transmission of substances, not to diagnose a condition or disease.
N/A
Intended Use / Indications for Use
Earloop Mask and Tie-On Mask is intended for use by healthcare workers to procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile.
Earloop Models: Blue (P10031), White (P10032), or Green (P10033)
Tie-On Models: Blue (P10041), White (P10042), or Green (P10043)
Product codes
FXX
Device Description
Earloop Mask and Tie-On Mask is a single use non-sterile three layer mask with outer layer (Layer #1) and inner layer (Layer #3) made of spunbound polypropylene and a middle layer (Layer #2) made with meltblown polypropylene filter. Layer #1 has either no pigment (White) or a pigment (Either Blue or Green). There are 2 options for the mask to be secured on the user, either earloops or 2 sets of ties. Earloops are made of urethane elastic fiber and the ties are made of spunbound polypropylene. The nosepiece is a pliable aluminum strip covered by a polypropylene spunbound material and is encased between Layers # 1 and 2 and is affixed in place by ultrasonic heat seal. The three layers of material are pleated 3 times and Layer #3 is folded over the two other layers in front of the Layer #1. An edge material with 30 gsm spunbound polypropylene material is wrapped around the 3 layers at the 2 lateral edges. All 4 edges are ultrasonically heat sealed and ties or earloops are attached inside the edge material and ultrasonically heat sealed. All of the materials in the Standard Earloop Mask and the Standard Tie-On Mask are latex free. All materials are being used in currently marketed devices.
Dimensions: 9.5 cm x 17.7 cm
Specifications:
Layer #1 (Outer Layer): Spunbound Polypropylene. 20 gsm. (Either White, Blue, Or Green)
White: No Pigment Blue Pigment: Indanthrene or CI Pigment Blue 60. CAS 81-77-6 Green Pigment: Phthalocyanine Green G. CAS 1328-53-6 9.5 cm x 17.7 cm
Layer #2 (Middle Layer): Meltblown Polypropylene. 25 gsm. White.
9.5 cm x 17.7 cm
Layer #3 (Inner Layer) Spumbound Polypropylene. 25gsm. White.
12.6 cm x 17.7 cm
Nosepiece: 10 cm x 0.2 cm Aluminum Wrapped in Polypropylene
Edge: Spunbound Polypropylene. 30gsm.
Length 9.5 cm. 3.0 cm width folded to 1.5cm. White.
Attached Using Ultrasonic Heat Seal.
Earloop: Urethane Elastic Fiber. #2. 17cm Long. White.
Attached Using Ultrasonic Heat Seal.
Ties: Spunbound Polypropylene. #4. 40gsm.
Total Length 95 cm. 2.4 cm width folded to 1.2 cm. White.
Attached Using Ultrasonic Heat Seal.
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
healthcare workers
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
Fluid Resistance: Pass at 80 mm Hg, 29 of 32 samples passed when tested using ASTM F1862/F1862M 13.
Particle Filtration Efficiency: 99.18% at 0.1 micron, tested using ASTM F2299/F2299M 03 (2010) with a non-neutralized challenge.
Bacterial Filtration Efficiency: 99.17%, tested using ASTM F2101 14.
Delta - P: 3.79 mmH2O/cm², tested using MIL-M-36954C.
Flammability Class: 1, tested using 16 CFR Part 1610.
Biocompatibility: Non-cytotoxic, non-irritating, and non-sensitizing, tested using ISO 10993 Part 5 and 10.
Latex: Not made with natural rubber latex, tested using ASTM D6499-12.
Key Metrics
Fluid Resistance: Pass at 80 mm Hg
Particle Filtration Efficiency: 99.18% at 0.1 micron
Bacterial Filtration Efficiency: 99.17%
Delta - P: 3.79 mmH2O/cm²
Flammability Class: 1
Biocompatibility: Non-cytotoxic, non-irritating, and non-sensitizing
Latex: Not Made With Natural Rubber Latex
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
Protect U Guard, LLC Mr. Brent Laartz President 1840 Mease Drive Suite 319 Safety Harbor, Florida 34695
Re: K153409
Trade/Device Name: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 10, 2016 Received: October 11, 2016
Dear Mr. Laartz:
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. 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153409
Device Name
Protect U Guard Earloop and Tie-On Mask (Blue, White, or Green)
Indications for Use (Describe)
Earloop Mask and Tie-On Mask is intended for use by healthcare workers to procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile.
Earloop Models: Blue (P10031), White (P10032), or Green (P10033)
Tie-On Models: Blue (P10041), White (P10042), or Green (P10043)
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 Druq 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
Image /page/3/Picture/0 description: The image shows the text "Protect-U-Guard" in blue font. The text is horizontally oriented and appears to be the main subject of the image. Behind the text is a gray circular shape that appears to be a logo or design element.
Protect U Guard, LLC 1840 Mease Drive Suite 319 Safety Harbor, FL 34695 (813) 815-0530
October 10 , 2016
510K SUMMARY
This 510K Summary information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510K number is: K153409
-
- Submitter's Identification:
Protect U Guard, LLC 1840 Mease Drive Suite 319 Safety Harbor, FL 34695 Telephone: (813) 815-0530 Fax: 1 (844)-821-4418
- Submitter's Identification:
Contact Person: Brent W. Laartz, MD, President blaartz@protectuguard.com
-
- Device Name:
Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
- Device Name:
-
- Device Common Name:
- a. Surgical Facemask
-
- Regulation Name, Device Product Code and Classification:
- a. Surgical Apparel
- b. FXX Class II
- c. 21 CFR 878.4040
4
Protect U Guard, LLC 1840 Mease Drive Suite 319 Safety Harbor, FL 34695 (813) 815-0530
-
- Device Description:
Earloop Mask and Tie-On Mask is a single use non-sterile three layer mask with outer layer (Layer #1) and inner layer (Layer #3) made of spunbound polypropylene and a middle layer (Layer #2) made with meltblown polypropylene filter. Layer #1 has either no pigment (White) or a pigment (Either Blue or Green). There are 2 options for the mask to be secured on the user, either earloops or 2 sets of ties. Earloops are made of urethane elastic fiber and the ties are made of spunbound polypropylene. The nosepiece is a pliable aluminum strip covered by a polypropylene spunbound material and is encased between Layers # 1 and 2 and is affixed in place by ultrasonic heat seal. The three layers of material are pleated 3 times and Layer #3 is folded over the two other layers in front of the Layer #1. An edge material with 30 gsm spunbound polypropylene material is wrapped around the 3 layers at the 2 lateral edges. All 4 edges are ultrasonically heat sealed and ties or earloops are attached inside the edge material and ultrasonically heat sealed. All of the materials in the Standard Earloop Mask and the Standard Tie-On Mask are latex free. All materials are being used in currently marketed devices.
- Device Description:
Dimensions: 9.5 cm x 17.7 cm
Specifications:
Layer #1 (Outer Layer): Spunbound Polypropylene. 20 gsm. (Either White, Blue, Or Green)
White: No Pigment Blue Pigment: Indanthrene or CI Pigment Blue 60. CAS 81-77-6 Green Pigment: Phthalocyanine Green G. CAS 1328-53-6 9.5 cm x 17.7 cm
5
Protect U Guard, LLC 1840 Mease Drive Suite 319 Safety Harbor, FL 34695 (813) 815-0530
Layer #2 (Middle Layer): Meltblown Polypropylene. 25 gsm. White.
9.5 cm x 17.7 cm
Layer #3 (Inner Layer) Spumbound Polypropylene. 25gsm. White.
12.6 cm x 17.7 cm
Nosepiece: 10 cm x 0.2 cm Aluminum Wrapped in Polypropylene
Edge: Spunbound Polypropylene. 30gsm.
Length 9.5 cm. 3.0 cm width folded to 1.5cm. White.
Attached Using Ultrasonic Heat Seal.
Earloop: Urethane Elastic Fiber. #2. 17cm Long. White.
Attached Using Ultrasonic Heat Seal.
Ties: Spunbound Polypropylene. #4. 40gsm.
Total Length 95 cm. 2.4 cm width folded to 1.2 cm. White.
Attached Using Ultrasonic Heat Seal.
-
- Intended Use:
Earloop Mask and Tie-On Mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile.
- Intended Use:
Earloop Models: Blue (P10031), White (P10032), or Green (P10033)
Tie-On Models: Blue (P10041), White (P10042), or Green (P10043)
Over-The-Counter Use
6
Protect U Guard, LLC 1840 Mease Drive Suite 319 Safety Harbor, FL 34695 (813) 815-0530
-
- Comparison to Predicate Device:
Predicate Device: Tiger Medical Products Earloop and Tie On Mask (K122717)
- Comparison to Predicate Device:
| Description | Our Device (K153409) | Predicate Device (K122717) |
|---|---|---|
| Materials | Spunbound Polypropylene | |
| Meltblown Polypropylene | Spunbound Polypropylene | |
| Meltblown Polypropylene | ||
| Dimensions | 9.5cm x 17.7 cm | Approx 9cm x 17 cm |
| Inner Layer | Spunbound Polypropylene | Spunbound Polypropylene |
| Middle Layer | Meltblown Polypropylene | Meltblown Polypropylene |
| Outer Layer | Spunbound Polypropylene | Spunbound Polypropylene |
| Nosepiece | Aluminum strip | Aluminum strip |
| Attachment | Urethane elastic fiber | |
| earloop or spunbound | ||
| polypropylene tie | Urethane elastic fiber | |
| earloop or spunbound | ||
| polypropylene tie | ||
| Mask Style | Earloop or Tie-On | |
| Flat Pleated | Earloop or Tie-On | |
| Flat Pleated | ||
| Fluid Resistance | Pass at 80 mm Hg | Fluid Resistant |
| Particle Filtration Efficiency | 99.18% at 0.1 micron | 99.54% at 0.1 micron |
| Bacterial Filtration Efficiency | 99.17% | >99.9% |
| Flammability Class | 1 | 1 |
| Delta - P | 3.79 mmH2O/cm² | 3.38 mmH2O/cm² |
| Biocompatibility | Under the conditions of the | |
| study, the device is non- | ||
| cytotoxic, non-irritating, and | ||
| non- sensitizing. | No Cytotoxicity | |
| No Sensitization | ||
| No Irritation | ||
| Latex | Not Made With Natural | |
| Rubber Latex | Latex Free | |
| Indications For Use | Earloop Mask and Tie-On | |
| Mask is intended for | ||
| use by healthcare workers | ||
| during procedures to | ||
| protect both patients and | ||
| healthcare workers against | ||
| transfer of microorganisms, | ||
| bodily fluids, and airborne | ||
| particles. This device is single- | ||
| use and provided non-sterile. | Surgical mask is intended for | |
| single use by operating room | ||
| personnel and other general | ||
| healthcare workers to | ||
| protect both patients and | ||
| healthcare workers against | ||
| transfer of microorganisms, | ||
| blood, and body fluids, and | ||
| airborne particulates. |
7
Protect U Guard, LLC 1840 Mease Drive Suite 319 Safety Harbor, FL 34695 (813) 815-0530
-
- Conformity to Standards outlined in the Guidance Document: "Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions." The below standards are outlined in the guidance document under the heading Risk To Health:
- a. Fluid Resistance
- i. ASTM F1862/F1862M 13. Standard test method for resistance of medical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ii. Fluid Resistance tested at 80 mm Hg, passed 29 of 32. Conforms to this standard for fluid resistance at 80mm Hg.
- iii. Adaptations, Deviation, or Differences from the Methods of the Conformance Standard: None.
- b. Adequate Barrier for Bacteria
- i. ASTM F2101 14. Standard test method for evaluating the bacterial filtration efficiency (BFE) of medical face mask materials, using a biological aerosol of staphylococcus aureus.
- Bacterial Filtration Efficiency tested at 99.17%. Conforms to this standard. ii.
- iii. Adaptations, Deviation, or Differences from the Methods of the Conformance Standard: None.
- Adequate Air Exchange ﻥ
- i. MIL-M-36954C. Differential Pressure (Delta-P)
- ii. Tested at a Delta P of 3.79 which corresponds to a comfort level of warm. Conforms to this standard.
- iii. Adaptations, Deviation, or Differences from the Methods of the Conformance Standard: None.
- d. Adequate Particlulate Barrier
- i. ASTM F2299/F2299M 03 (2010). Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres. With the exception of the procedure incorporated a non-neutralized challenge. In real use, particles carry a charge, thus this challenge represents a more natural state. The non-neutralized aerosol is also specified in the FDA guidance document on surgical face masks.
- Particulate Filtration Efficiency result was 99.18% for particles of 0.1 micron. ii. Conforms to this standard.
- Adaptations, Deviation, or Differences from the Methods of the Conformance iii. Standard: None, except the procedure incorporated a non-neutralized
8
Protect U Guard, LLC 1840 Mease Drive Suite 319 Safety Harbor, FL 34695 (813) 815-0530
challenge. In real use, particles carry a charge, thus this challenge represents a more natural state. The non-neutralized aerosol is also specified in the FDA guidance document on surgical face masks.
- e. Flammability
- i. Code of Federal Regulations (CFR): 16 CFR Part 1610. Standard for the Flammability of Clothing Textiles.
- ii. Flammability testing Passed as a Class 1. Conforms to this standard. See Nelson Labs report following.
- Adaptations, Deviation, or Differences from the Methods of the Conformance iii. Standard: None except, anhydrous calcium chloride was used as a desiccant rather than anhydrous silica gel. This is not expected to alter testing results.
- f. Biocompatibility
- i. ISO 10993 Part 5 and 10. Biological evaluation of medical devices. Part 5: Tests for in vitro cytotoxicity. Part 10: Tests for irritation and skin sensitization.
- ii. Under the conditions of the study, the device is non-cytotoxic, non-irritating, and non-sensitizing.
- iii. Adaptations, Deviation, or Differences from the Methods of the Conformance Standard: For Skin Sensitization, the Guinea Pig Buehler Sensitization Test is chosen as the most appropriate option. For Cytotoxicity, the Minimal Essential Media (MEM) option was chosen which conforms to the standard. Otherwise No deviations.
g. Latex
- i. ASTM D6499-12. Standard test method for the immunological measurement of antigenic protein in natural rubber and its products.
- Not made with natural rubber latex. ii.
- iii. Adaptations, Deviation, or Differences from the Methods of the Conformance Standard: None.
9. Conclusions:
Materials, intended use, mask style, design features, and performance test results of Earloop Mask and Tie-On Mask are similar to the predicate device. The Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is substantially equivalent to the Predicate Device.