(123 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No.
The device's intended use is to protect healthcare personnel from microorganisms, body fluids, and particulate material, and to reduce exposure to blood and body fluids. It is a protective barrier, not a device used to treat or cure a disease or condition.
No
The device description indicates it is a surgical face mask intended to protect against transfer of microorganisms and fluids, not to diagnose a medical condition.
No
The device description clearly outlines physical components like spun-bond polypropylene, melt blown polypropylene filter, ear loops, and adjustable nose wire, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- Device Intended Use: The intended use of the Velguard Surgical Face Mask is to be worn on the face to protect the wearer and others from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier worn on the body.
- Device Description: The description details the physical construction of a mask, not a device designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, breathability, flammability, biocompatibility) related to its function as a barrier, not on the accuracy of analyzing biological samples.
The information provided clearly describes a surgical face mask, which is a personal protective equipment (PPE) device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Velguard Surgical Face Mask is intended to be worn to protect 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 nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Velguard Surgical Face Mask is a single use, three pleated, flat-folded rectangular masks with ear loops and adjustable nose wire. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The inner spun-bond polypropylene layer uses no colorant. The outer spun-bond polypropylene layer uses a blue colorant. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene coated zinc wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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)
Non-clinical tests were conducted on 32 samples per lot, three non-consecutive lots. The tests were in accordance with the recommendations included in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004 and the following FDA recognized consensus standards:
ASTM F1862 - Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
ASTM F2299 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F2101 - Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
EN 14683 - Standard Test Method for Differential Pressure
16 CFR Part 1610 - Standard for the Flammability of Clothing
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance: Three lots passed at 160mm Hg - ASTM F1862
Particulate Filtration Efficiency: Three lots passed at ≥98% @ 0.1 micron - ASTM F2299
Bacterial Filtration Efficiency: Three lots passed at ≥98% – ASTM F2101
Differential Pressure: Three lots passed at
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "ADMINISTRATION".
August 3, 2021
Esstee Exports Health Care Division % Amy Fowler Regulatory Counsel Pathmaker FDA Law, PLLC 901 Twelve Oaks Center Drive Wayzata, Minnesota 55391
Re: K210761
Trade/Device Name: Velguard Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX
Dear Amy Fowler:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 16, 2021. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, OHT4: Office of Surgical and Infection Control Devices, 301-796-0270, Clarence. Murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
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 Quality Center for Devices and Radiological Health
1
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July 16, 2021
Estee Exports Health Care Division % Amy Fowler Regulatory Counsel Pathmaker FDA Law, PLLC 901 Twelve Oaks Center Drive Wayzata, Minnesota 55391
Re: K210761
Trade/Device Name: Velguard Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: June 11, 2021 Received: June 14, 2021
Dear Amy Fowler:
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
2
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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ryan Ortega -S
Ryan Ortega, PhD 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
3
Indications for Use
510(k) Number (if known) K210761
Device Name Velguard Surgical Face Mask
Indications for Use (Describe)
The Velguard Surgical Face Mask is intended to be worn to protect 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 nonsterile.
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 | |
---|---|
Velguard Surgical Face Mask (K210761) | |
Sponsor Information: | Esstee Exports Health Care Division |
8/3176 A3 & A4, Jothipuram, 2nd Street, | |
Pandian Nagar, PN Road, | |
Tirupur, Tamil Nadu, India 641602 | |
Sponsor Contact: | |
Zachary Wilson | |
Lacote Supply, Inc. | |
880 N Ventura Ave, Ste G | |
Oak View, CA 93022 | |
Em: zwilson@lacotesupply.com | |
Ph: 805-365-1348 | |
Contact Person: | Amy Fowler |
Regulatory Counsel | |
Pathmaker FDA Law, PLLC | |
901 Twelve Oaks Center Drive | |
Suite 936 | |
Wayzata, Minnesota 55391 | |
Em: fowler@pathmakerlaw.com | |
Ph: 612-356-9653 | |
Date of Summary Preparation: | June 11, 2021 |
Proprietary Name: | Velguard Surgical Face Mask, Model Number VG3MCB |
Common Name: | Surgical Mask |
Device Classification: | Class II |
Classification Name: | Surgical Apparel |
Regulation Medical Specialty: | General and Plastic Surgery |
Review Panel: | General Hospital |
Product Code: | FXX |
Regulatory Class: | Class II |
Predicate Device: | Surgical Face Mask (K182515) - Model Ear Loop |
(no known design-related recalls) |
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Image /page/5/Picture/1 description: The image shows the logo for Esstee Health Care Division. The logo features the word "esstee" in green letters, with a red line running through the first "s" and under the entire word. A needle and thread are incorporated into the logo, with the needle forming the "l" in "esstee" and the red thread looping through the needle's eye. Below the word "esstee" is the phrase "Health Care Division" in smaller, black letters.
| Device Description: | The Velguard Surgical Face Mask is a single use, three pleated,
flat-folded rectangular masks with ear loops and adjustable nose
wire. The Surgical Masks are manufactured with three layers, the
inner and outer layers are made of spun-bond polypropylene, and
the middle layer is made of melt blown polypropylene filter. The
inner spun-bond polypropylene layer uses no colorant. The outer
spun-bond polypropylene layer uses a blue colorant. The ear
loops are held in place over the users' mouth and nose by two
elastic ear loops welded to the facemask. The elastic ear loops are
not made with natural rubber latex. The nose piece in the layers
of facemask is to allow the user to fit the facemask around their
nose, which is made of malleable polyethylene coated zinc wire.
The surgical face masks are sold non-sterile and are intended to
be single use, disposable devices. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for
Use: | The Velguard Surgical Face Mask is 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 |
| Item(s) | Subject Device (K210761)
Velguard Surgical Face Mask | Predicate Device (K182515)
Surgical Face Mask | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Velguard Surgical Face
Mask is 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 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(s),
provided non-sterile | Same, minor
differences to
correct grammar. |
| Type of Use | Over-The-Counter Use (21
CFR 801 Subpart C) | Over-The-Counter Use (21
CFR 801 Subpart C) | Same |
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene
filter | Melt blown polypropylene
filter | Same |
| Item(s) | Subject Device (K210761)
Velguard Surgical Face Mask | Predicate Device (K182515)
Surgical Face Mask | Comparison |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Malleable polyethylene
coated zinc wire | Malleable polyethylene wire | Similar, both nose
pieces use
malleable
polyethylene. The
subject device nose
piece is enclosed
within the layers. |
| Ear loops | Polyester spandex blend | Spandex | Similar, both use
spandex for
elasticity. |
| Color(s) | Blue & White | Yellow | Different, the
difference in
colorants does not
raise concerns of
safety or
effectiveness.
Biocompatibility
testing
demonstrated the
subject device was
non-cytotoxic,
non-irritating, and
non-sensitizing. |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Length | 17.5cm ±0.5cm | 17.5cm±0.2cm | Similar |
| Width | 9.5cm ±0.3cm | 9.5cm±0.2cm | Similar |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| Performance
Testing | Level 3 - ASTM
F2100-19 | Level 2 - ASTM
F2100-11 | Different, subject
devices exceeded
predicate device in
one performance
test. ASTM F2100-
19 uses different
test method for
measuring Delta-P
(H2O/cm2). |
| Item(s) | Subject Device (K210761)
Velguard Surgical Face Mask | Predicate Device (K182515)
Surgical Face Mask | Comparison |
| Fluid Resistance
Performance | Three lots passed at 160mm
Hg - ASTM F1862 | 32/32 passed at 120 mmHg -
ASTM F1862 | Similar,
subject device
exceeded fluid
resistance of the
predicate device. |
| Particulate
Filtration
Efficiency | Three lots passed at ≥98% @
0.1 micron - ASTM F2299 | pass at 99.7% - ASTM F2299 | Similar, both
devices meet ASTM
F2299. |
| Bacterial
Filtration
Efficiency | Three lots passed at ≥98% –
ASTM F2101 | pass at 99.9% - ASTM F2101 | Similar, both
devices meet ASTM
F2101. |
| Differential
Pressure | Three lots passed at