(94 days)
Not Found
No
The device is a physical surgical mask and the description focuses on its materials, construction, and performance in standard filtration and safety tests. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a surgical mask intended for protection and infection control, not for treating a disease or condition.
No
Explanation: The device is a surgical mask intended for protection against microorganisms and particulate material, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, multi-layer surgical mask made of polypropylene, nylon/spandex, and metal. The performance studies focus on physical properties like filtration efficiency, pressure, flammability, and resistance to penetration, all characteristic of a hardware medical device. There is no mention of software components or functionality.
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 users and patients from the transfer of microorganisms, body fluids, and particulate material. 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 and materials of the mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the mask's physical properties related to filtration, breathability, flammability, and resistance to penetration. These are not studies related to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: IVDs are designed to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
Therefore, based on the provided information, the Puravita Medical Fold Flat Surgical Mask is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PuraVita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The PuraVita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device that is provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with 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
patients 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)
Bench Performance Testing
The following tests were performed on 32 samples of PuraVita Medical Fold Flat Surgical Masks from 3 non-sequential lots (total of 96 samples):
- Bacterial Filtration Efficiency (BFE) ASTM F2101-19: All 96 samples met the "pass" criteria (≥ 98% filtration efficiency) for levels 2 and 3.
- Differential Pressure (Delta-P) EN 14683:2019 + AC 2019 (E) Annex C: All 96 samples measured an average differential pressure of 5.3mmH2O/cm2, passing the test with a 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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December 2, 2021
Puravita M, LLC % Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC P.O. Box 56436 Virginia Beach, Virginia 23456
Re: K212740
Trade/Device Name: Puravita Medical Fold Flat Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: August 30, 2021
Dear Rhonda Alexander:
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 Clarence W. Murray, III, Ph.D. 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)
K212740
Device Name Puravita Medical Fold Flat Surgical Mask
Indications for Use (Describe)
The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device that is provided non-sterile.
| 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) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K212740
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date of Summary: November 24, 2021
Contact Information
| Submitter: | Submitter Contact: |
|---|---|
| PuraVita M, LLC | Jefferson Nemelka |
| 1287 W 300 S | Plant Manager |
| Lindon, UT 84042 | 801-836-7940 |
| jefferson@puravita.com |
| Consultant: | Dr. Rhonda Alexander |
|---|---|
| Sr. Consultant, Regulatory Strategy | |
| IUVO Consulting, LLC | |
| (757) 582-4337 | |
| ralexander@iuvoconsulting.com |
Device Information
| Trade Name: | PuraVita Medical Fold Flat Surgical Mask |
|---|---|
| Common Name: | Surgical Face Mask |
| Classification Name: | Mask, Surgical |
| Classification: | Class II per 21 CFR 878.4040 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
Predicate Device:
| Manufacturer: | Guangdong Kingfa Sci. & Tech. Co., Ltd, |
|---|---|
| Product: | Medical Protective Mask |
| 510(k) Number: | K202107 |
Intended Use Statement:
The PuraVita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The PuraVita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device that is provided non-sterile.
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Device Description:
The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with natural rubber latex.
| Device | Predicate Device: K202107
Guangdong Kingfa Sci. & Tech. Co.,
LTD, Medical Face Mask, Model
KF-A F02(N) | Subject Device: K212740
PuraVita Medical Fold Flat
Surgical Mask | Comparison |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for
Use | The Medical Protective Mask is
intended to be worn to protect both the
patient and healthcare personnel from
transfer of microorganisms, body
fluids and particulate material. The
Medical Protective Mask is 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 PuraVita Medical Fold Flat
Surgical Mask is intended to be worn
to protect both patients and healthcare
personnel from transfer of
microorganisms, body fluids, and
particulate material. The PuraVita
Medical Fold Flat Surgical Mask is
intended for use in infection control
practices to reduce the potential
exposure to blood and body fluids.
This is a single-use, disposable device
that is provided non-sterile. | Similar |
| Materials | | | |
| Outer Layer | Polypropylene spunbond | Polypropylene spunbond | Same |
| Middle Filter Layer
#1 | Polypropylene Meltblown | Polypropylene Meltblown | Same |
| Middle Filter Layer
#2 | Non-woven Polypropylene | Polypropylene Meltblown | Different. Although
the 2nd filter layer of
the subject device is
different than the
predicate device, the
device met all
standards when tested. |
| Inner Layer | Polypropylene spunbond | Polypropylene spunbond | Same |
| Ear Loops | Spandex and Polyester | Spandex and Nylon | Different. Although
the material used in the
subject device is
slightly different than
the predicate device, it
passed all
biocompatibility test
requirements. |
| Nose Piece | Iron core polypropylene strip | Dual Iron core polypropylene strip | Similar |
| Latex | Not made with natural rubber latex | Not made with natural rubber latex | Same |
| Description | | | |
| Color | White | White | Same |
| Style | Extended chamber flat-folded | Fold Flat | Similar |
| Single Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-sterile | Same |
| Length | $16.2cm ± 0.5cm$ | $16.3cm ± 0.5cm$ | Different. Although
the specifications and
dimensions of the
subject device are
slightly different than
the predicate device. |
| | | | the predicate device,
the differences are
minimal. |
| Width | $10.2cm \pm 0.5cm$ | $10.6cm \pm 0.5cm$ | Different. Although
the specifications and
dimensions of the
subject device are
slightly different than
the predicate device,
the differences are
minimal. |
| Performance Testing | | | |
| ASTM
Performance Level | ASTM Level 2 | ASTM Level 3 | Different. Although the
performance of the
subject device differs
from that of the
predicate device, the
subject device performs
at least as well as the
predicate. |
| Fluid/Blood
Penetration F1862 | Pass at 120 mmHg | Pass at 160mmHg | Different, however the
subject device filters as
well as the predicate
device. |
| Particulate
Filtration F2299 | 99.1%, filtration efficiency | >99.4% filtration efficiency | Different; however, the
subject and predicate
devices both pass the
test at ≥98% filtration
efficiency. |
| Bacterial Filtration
F2101 | 99.9% | >99.9% | Same |
| Diff. Pressure
(Delta-P)
MIL-M-36954C | On average of 5.04 mmH2O/cm2 | On average 5.3 mmH2O/cm2 | Different, both the
subject device and
predicate device pass
the test with a
differential pressure
99.1% FiltrationEfficiencyPass$ | $\ge 98% FiltrationEfficiencyPass$ | Similar, both the subject
device and predicate
device passed the test at
the same level ( $\ge$ 98%). |
| Differential
Pressure (Delta-
P) | Test articles used in
the test | Test methods and
procedures
(including any | Study endpoint, i.e., the
specific parameter | None | All 96 samples measured
an average differential | Differential Pressure
(Delta-P) | $