(217 days)
No
The 510(k) summary describes a standard surgical face mask and its performance characteristics based on physical filtration and material properties. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
A surgical face mask is primarily intended to block or filter the transfer of microorganisms, body fluids, and airborne particles, which is a barrier function rather than a direct therapeutic effect on a medical condition.
No
The device is a surgical face mask, which primarily serves as a barrier to prevent the transfer of microorganisms and particles, and does not perform any diagnostic function.
No
The device description clearly outlines a physical, multi-layered surgical face mask made of polypropylene with ear loops and a nose piece. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware devices, not software.
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 airborne particles by being worn on the face. This is a physical barrier function.
- Device Description: The description details the physical construction and materials of the mask.
- Performance Studies: The performance studies focus on the mask's ability to filter particles and fluids, its breathability, flammability, and biocompatibility when in contact with the skin. These are all related to its function as a physical barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside of the body on samples taken from the body. This surgical face mask is a personal protective equipment (PPE) device that acts as a physical barrier.
N/A
Intended Use / Indications for Use
When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
Product codes
FXX
Device Description
Ideal Med Pro 3-Ply Disposable Face Mask is a 3-ply, flat-pleated style surgical mask. The device is manufactured with three layers. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. Each mask contains elastic ear loops to secure the mask over the user's face and mouth with nose piece to fit firmly over the nose.
This device is not made from any natural rubber latex.
The product is sold non-sterile and intended to be disposable for single-use.
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 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
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| Test Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM F2101 | Bacterial Filtration Efficiency (BFE) | 98% | 99.9% |
| ASTM F2299 | Particulate Filtration Efficiency (PFE) | 98% | 99.9% |
| ASTM F1862 | Synthetic Blood Fluid Resistance | 29 out of 32 pass at 120 mmHg | 30, 31, and 32 pass at 120 mmHg, out of 32 test articles in each of three lots (96 total test articles) |
| MIL-M-36954C | Differential Pressure (Delta P) | 3.5 sec (Class 1) | IBE for all 8 test articles in each of 3 lots (24 total test articles) |
Key Metrics
- Bacterial Filtration: 99.9%
- Particle Filtration: 99.9%
- Fluid Resistance: 93 of 96 pass @ 120 mmHg
- Differential Pressure:
§ 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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January 13, 2023
JSN Holdings, LLC % John F. Gillespy, MBA President FDA 510K Consultants, LLC 1100 Del Lago Circle #104 Palm Beach Gardens, Florida 33410
Re: K221682
Trade/Device Name: Ideal Med Pro 3-Ply Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 28, 2022 Received: December 5, 2022
Dear Mr. Gillespy:
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 mediation-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,
Brent Showalter -S
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) K221682
Device Name IDEAL MED PRO 3-PLY DISPOSABLE FACE MASK
Indications for Use (Describe)
When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
_ | 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
Prepared in accordance with the requirements of 21 CFR Part 807.92.
| | 1. 510(k) Submitter: | JSN Holdings, LLC
1735 Dilworth Road East, Matthews, NC 28203
Phone: 201-247-5838
Email: brian@bpamericas.com | |
|--|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | 2. Company Contact: | Brian Tedesco, President | |
| | 3. Date of Submission: | September 10, 2022 | |
| | 4. 510(k) Preparer: | John F. Gillespy, MBA
FDA 510k Consulting, LLC
Palm Beach Gardens, FL 33410
Phone: 386-243-4332
Email: john@fda510kconsultants.com | |
| | 5. Device Classification: | Trade name:
Common name:
Device:
Class:
Regulation #:
Product Code: | Ideal Med Pro 3-Ply Disposable Face Mask
Surgical Face Mask
Surgical Mask
II
878.4040
FXX |
| | 6. Predicate: | Applicant:
Device:
510(k) Number: | Mexpo International, Inc.
Avianz Surgical Face Mask
K200847 |
7. Device Description
ldeal Med Pro 3-Ply Disposable Face Mask is a 3-ply, flat-pleated style surgical mask. The device is manufactured with three layers. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. Each mask contains elastic ear loops to secure the mask over the user's face and mouth with nose piece to fit firmly over the nose.
This device is not made from any natural rubber latex.
The product is sold non-sterile and intended to be disposable for single-use.
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8. Indications For Use
When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
The device is intended for OTC use.
9. Comparison To Predicate Device
ldeal Med Pro 3-Ply Surgical Face Mask is compared to a predicate device, Avianz Surgical Face Mask (K200847). The predicate selection conforms to FDA's guidance document, "Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (July 2014).
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | JSN Holdings, LLC | Mexpo International, Inc. | - |
| 510K Number | K221682 | K200847 | - |
| Product Name | Surgical Face Mask | Surgical Face Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intended Use | When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only. | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only. | Same |
| Model | 3-Ply, Ear Loops, Flat-Pleated Style | 3-Ply, Ear Loops, Flat-Pleated Style | Same |
| Materials, Dimensions, & Other Features | |||
| Outer Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown Polypropylene Filter | Melt Blown Polypropylene Filter | Same |
| Inner Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanize Wire, Coated By PE | Single Galvanize Wire, Coated By PE | Same |
Comparison Table
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| Ear Loops | Not made with natural
rubber latex | Not made with natural
rubber latex | Same |
|-----------------------|---------------------------------------|---------------------------------------|-----------|
| Color | Blue (inner facing) & white | White | Similar |
| Dimension (Width) | 9.5cm ± 0.5cm | 9.0cm ± 0.5cm | Similar |
| Dimension (Length) | 17.5cm ± 0.5cm | 17.5cm ± 0.5cm | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Testing | | | |
| Performance Level: | | | |
| ASTM F2100:2019 | Level 2 | Level 2 | Same |
| Bacterial Filtration | 99.9% | 98% | Both Pass |
| Particle Filtration | 99.9% | 98% | Both Pass |
| Fluid Resistance | 93 of 96 pass @ 120 mmHg | 29 of 32 pass @ 120 mmHg | Both Pass |
| Differential Pressure | 3.5 sec (Class 1) | IBE for all 8 test articles in each of 3 lots (24 total test articles) |
11. Patient-Contacting Materials
Materials composition follows:
- . Outer facing layer – spunbond polypropylene (blue)
- . Middle layer – melt blown polypropylene filter (white)
- . Inner facing layer – spunbond polypropylene (white)
- . Nose piece – white aluminum strip with polypropylene covering
- . Ear loops – spandex and nylon, not made from natural rubber latex (white)
4 NOSE CLIP
Flexible metal plate
3 INNER SOFT LAYER
Absorbent non-woven layer
2 MIDDLE LAYER
High density filter
3 LAYER OF
PROTECTION
1 OUTER BLUE LAYER
Hydrophobic non-woven layer
The outer & inner layers and ear loops touch the patient's face and hands. Type and duration of contact with patient follows:
- Surface contact – intact skin
- Limited duration – less than 24 hours
-
- Software Verification and Validation... The mask contains no software or firmware.
-
- Substantial Equivalence
7
Many of the subject device's features and technical characteristics are identical to those of the predicate device, and where there are differences, such differences do not have an impact on the safety or effectiveness of the subject device.
The subject device successfully followed the pathway to Substantial Equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (2014). The steps are summarized below:
- The predicate device is legally marketed and was found substantially equivalent through 510(k) premarket submission.
- The subject and predicate devices have the same intended use (and indications for use).
- Technological differences between the subject and predicate were evaluated; none of the differences raised different issues of safety and effectiveness.
- The following methods for evaluation of the effects of different characteristics on safety and effectiveness were deemed acceptable-testing for performance characteristics and biocompatibility. All evaluation methods were conducted to FDA-recognized standards.
- Data from these tests demonstrated equivalence and support the indications for use.
In summary, all necessary testing has been performed and the results support the conclusion that Ideal Med Pro 3-Ply Surgical Face Mask is substantially equivalent to the legally marketed predicate based on both (a) comparison of intended use, materials, technology, and design and (b) testing to FDA-recognized standards, and the device thus does not raise any concerns of safety or effectiveness.
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K202516, Ideal Med Pro 3-Ply Disposable Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200847.