(63 days)
Not Found
No
The device description and performance studies focus on material properties and physical filtration, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical mask intended for protection and infection control, not for therapy.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. This device, a surgical mask, is intended for protection from transfer of microorganisms and body fluids, not for diagnosis.
No
The device description clearly outlines a physical, multi-layered mask made of various materials (polypropylene spunbond, melt-blown, thermal-bonded) with ear loops and a nose piece. The performance studies are benchtop tests on the physical properties of the mask, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "High Fluid-Resistant Surgical and Procedure Mask." Its intended use is to act as a physical barrier to protect against the transfer of microorganisms, body fluids, and particulate material. It does not analyze any biological specimens.
- Intended Use: The intended use focuses on protection and infection control by creating a physical barrier, not on analyzing samples for diagnostic purposes.
- Device Description: The description details the physical construction and materials of the mask, not components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility) as a barrier, not on the accuracy or reliability of analyzing biological samples.
Therefore, based on the provided information, this surgical mask is a medical device used for protection and infection control, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The High Fluid-Resistant Surgical and Procedure 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 potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose.
This 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
Healthcare personnel, infection control practices
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)
Benchtop Performance Testing:
- ASTM F1862/ISO 22609 Fluid Resistance: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. Results: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass. All passed.
- ASTM F2299 Particulate Filtration Efficiency: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Results: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass. All passed.
- Bacterial Filtration Efficiency ASTM F2101: Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. Results: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass. All passed.
- Differential Pressure ASTM F2100/EN 14683:2019: Three non-sequential lots of 32 (total of 96) 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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 14, 2022
America's Supply Chains % Prithul Bom, MBA, MS, RAC (US, EU), CSQE Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114
Re: K222749
Trade/Device Name: High Fluid-Resistant Surgical and Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 31, 2022 Received: November 1, 2022
Dear Ms. Bom:
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) K222749
Device Name
High Fluid-Resistant Surgical and Procedure Mask
Indications for Use (Describe)
The High Fluid-Resistant Surgical and Procedure 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 intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is a single use, disposable device, 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) |
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Image /page/3/Picture/1 description: The image contains the logo for "America's Supply Chains." The logo features the text "America's" in a bold, blue font, with the "A" being significantly larger than the rest of the letters. Below "America's" is the text "Supply Chains" in a smaller, sans-serif font. Above the text is a circular emblem containing a stylized image of a building with columns, suggesting a government or institutional connection.
510(k) Summary
This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 8807.92:
I. SUBMITTER
America's Supply Chains 7555 Warren Pkwy, Unit 486 Frisco, TX 75034 USA
Contact Person:
Paul Park Tel: (617) 800-3602 Email: americasupplychains@gmail.com Date Prepared: September 06, 2022
II. DEVICE
Name of Device: High Fluid-Resistant Surgical and Procedure Mask Common or Usual Name: Surgical Mask Classification Name: Surgical Apparel Regulatory Class: Class II (21 CFR §878.4040) Regulation Medical Specialty: General & Plastic Surgery 510k Review Panel: General Hospital FXX Product Code:
III. PREDICATE DEVICE
Predicate Manufacturer: Predicate Trade Name:
Predicate 510(k):
3M Health Care 3MTM High Fluid- Resistant Procedure Mask Model Number 1840 K191355
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IV. DEVICE DESCRIPTION
The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose.
This device is not made from natural rubber latex.
V. INDICATIONS FOR USE
The High Fluid-Resistant Surgical and Procedure 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 potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in Table 1 below.
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| Description | Subject Device
High Fluid-Resistant
Surgical and Procedure
Mask ASTM Level 3 | Predicate Device (K191355)
1840 3M™ High
Fluid-Resistant Procedure
Mask ASTM Level 3 | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use/
Indications
for Use | The High fluid-Resistant
Surgical and Procedure Mask
is intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
material. This face mask is
intended for use in infection
control practices to reduce
potential exposure to blood
and body fluids. This is a
single use, disposable device,
provided non-sterile. | 3M™ High Fluid- Resistant
Procedure 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 potential
exposure to blood and body
fluids. This is a single use,
disposable device, provided
non-sterile. | Same |
| Materials | | | |
| Outer Cover
Web | Polypropylene Spunbond,
white | Polypropylene Spunbond,
green | Similar
(Subject
device does
not have
colorant) |
| Insertion | Polypropylene Spunbond,
white | Polypropylene Spunbond,
white | Same |
| Filter Web
(Middle) | Polypropylene Meltblown,
white | Polypropylene Meltblown,
white | Same |
| Inner Cover
Web | Polypropylene
Thermalbonded, white | Polypropylene
Thermalbonded, white | Same |
| Nose Piece | Polyethylene Coated Steel
Wire | Polyethylene Coated Steel
Wire | Same |
| Ear Loops | Spandex elastic cord | Spandex elastic cord | Same |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple
Layers | 4-Ply | 4-Ply | Same |
| Colors | White (Outer) | Green (Outer) | Different
(Subject
device does
not have
colorant) |
| Dimension
(Width) | $3.5" \pm 0.3"$ | $3.5" \pm 0.3"$ | Same |
| Dimension
(Length) | $6.9" \pm 0.2"$ | $6.9" \pm 0.2"$ | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100
Level | Level 3 | Level 3 | Same |
[Table 1: Comparison of Predicate Devices]
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Image /page/6/Picture/1 description: The image contains the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is a circular emblem containing a stylized image of a building with a red roof and blue columns. The overall design is clean and professional, suggesting a company involved in logistics or supply chain management.
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Image /page/7/Picture/0 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is a circular emblem with a building with columns inside of it. The building is blue and white, and the roof is red.
VII. PERFORMANCE DATA
The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2.
| Item | Proposed Device
High Fluid-Resistant
Surgical and Procedure
Mask
ASTM Level 3 | ASTM Level 3
Mask
Standard
Acceptance
Criteria | Predicate
Device
(K191355)
3MTM High
Fluid-Resistant
Procedure
Mask
ASTM Level 3 | Result |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------|
| ASTM
F1862/ISO
22609
Fluid
Resistance | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at 160mmHg
Lot 1: 32 /32 pass
Lot 2: 32 /32 pass
Lot 3: 32 /32 pass | AQL 4%,
single sampling
plan, 29 out of
32 Pass at
160mmHg | 32/32 Passed at
160mm Hg | Pass |
| ASTM F2299
Particulate
Filtration
Efficiency | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at ≥98%
Lot 1: 32/32 pass
Lot 2: 32/32 pass
Lot 3: 32/32 pass | ≥ 98% | 32/32 Passed at
≥98% @ 0.1
micron | Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at ≥98%
Lot 1: 32/32 pass
Lot 2: 32/32 pass
Lot 3: 32/32 pass | ≥ 98% | 31/32 Passed at
≥98% | Pass |
| Differential
Pressure
ASTM | Three non-sequential lots
of 32 (total of 96) passed
at