(21 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on material properties and physical performance metrics of a surgical face mask, with no mention of AI or ML.
No
Explanation: The device is described as a "Disposable Surgical Face Mask" intended to protect from transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. It does not state that it cures or treats a disease or condition, which is a characteristic of a therapeutic device.
No
The device description clearly states its purpose is to protect from transfer of microorganisms and body fluids, and the performance studies evaluate its fluid resistance, filtration, and flammability. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly outlines physical components (polypropylene layers, ear-loops, nose piece) and performance studies focus on material properties and physical resistance, not software functionality.
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 protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask, focusing on its barrier properties and fit. There is no mention of reagents, samples, or any components used for analyzing biological specimens.
- Performance Studies: The performance studies focus on the mask's physical properties like fluid resistance, filtration efficiency, and breathability. These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This is a single use, disposable device provided non-sterile.
Product codes
FXX
Device Description
The KDI Med Supply surgical face mask is with blue outer color layer and white inner and middle layer. Subject device is a flat pleated type mask, utilizing ear loop way for wearing, and it has a nose piece designed for fitting the face mask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner layer (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The masks contains a malleable nose piece to provide a firm fit over the nose and to secure the mask over the users mouth and face. The mask has level II fluid resistance under ASTM F2100. The mask is a single use, provided nonsterile. This product contains no components 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
To be worn to protect both the patient and healthcare provider.
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 F2100 Level: II (Subject Device and Predicate Device), Result: PASS
- Fluid resistance (ASTM F1862): 32 out of 32 pass at 120 mmHG (16.0 kPa) for Subject Device, 31 out of 32 pass at 120 mmHg (16.0 kPa) for Predicate Device, Result: PASS
- Particulate Filtration (ASTM F2299): >99.99% for Subject Device, > 99% for Predicate Device, Result: PASS
- Bacterial Filtration (ASTM F2101): >99.9% for Subject Device, > 99% for Predicate Device, Result: PASS
- Differential Pressure (Delta-P) (ASTM F2100): 8 Liters per minute (L/min) 98%, Results: > 99.99%
- ASTM F2101 (Bacterial Filtration): Acceptance Criteria: >98%, Results: >99.99%
- 16 CFR 1610 (Flammability): Acceptance Criteria: Class 1, Results: Class 1
- ASTM F2100 (Differential Pressure (Delta-P)): Acceptance Criteria: 99.99% (Subject Device) and >99% (Predicate Device); Acceptance Criteria: >98% and Results: > 99.99%.
Bacterial Filtration Efficiency (ASTM F2101): >99.9% (Subject Device) and >99% (Predicate Device); Acceptance Criteria: >98% and Results: >99.99%.
Differential Pressure (Delta-P) (ASTM F2100):
§ 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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 25, 2022
KDI Med Supply % Prithul Bom Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220637
Trade/Device Name: 3 Ply Medical Grade Single Use Procedural Disposable Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: March 3, 2022 Received: March 4, 2022
Dear Prithul 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.
1
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 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.
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
2
Indications for Use
510(k) Number (if known) K220637
Device Name
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Indications for Use (Describe)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for KDI Med Supply, which features a blue square, a gray square, and a dark blue square with a white plus sign in the middle. To the right of the squares is the text "KDI MED SUPPLY" in gray, blue, and black. To the right of the logo is a blue face mask with white ear loops and a "Made in USA" logo.
510(k) SUMMARY - K220637
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
Type of Submission: Traditional
Date Prepared: 3/24/2022
Device Type: Surgical Mask
l. SUBMITTER
KDI Med Supply 206 Lynn St. Fremont, OH 43420 USA Phone: (567) 280-9936 or (419) 307-0305 Fax: N/A
Contact Person: Yolanda Davis Email: kevin@kdimedsupply.com
ll. SUBJECT DEVICE
| Device/Trade Name: | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask |
|---|---|
| Classification Name: | Mask, Surgical |
| Regulation: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Common Name: | Level 2 Medical Grade Mask |
| Device Panel: | General Hospital |
| Product Code: | FXX |
lll. PREDICATE DEVICE
Manufacturer: Qiqihar Hengxin Medical Supplies, Ltd. Trade/Device Name: Single-Use Surgical Mask with Ear Loop (K201691)
No reference devices were used in this submission.
4
IV. DEVICE DESCRIPTION
The KDI Med Supply surgical face mask is with blue outer color layer and white inner and middle layer. Subject device is a flat pleated type mask, utilizing ear loop way for wearing, and it has a nose piece designed for fitting the face mask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner layer (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The masks contains a malleable nose piece to provide a firm fit over the nose and to secure the mask over the users mouth and face. The mask has level II fluid resistance under ASTM F2100. The mask is a single use, provided nonsterile. This product contains no components made with natural rubber latex.
V. INDICATIONS FOR USE
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider 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 bodily fluids. This is a single use, disposable device provided nonsterile.
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
| Feature | Subject Device:
3 Ply Medical Grade
Single Use Procedural
Disposable Face Mask
(K220637) | Predicate Device:
Single-Use Surgical
Face Mask with Ear
Loop (K201691) | Result |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indications for Use | The
Disposable
Surgical Face Masks
are intended to be
worn to protect both
the patient and
healthcare provider
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
bodily fluids. | The single-use
surgical mask with
ear loop is intended
to be worn to protect
both the patient and
healthcare personnel
from the transfer of
microorganisms,
body fluids, and
particulate material.
The Single Use
Surgical Mask with
ear loop is intended
for use in infection
control practices to
reduce the potential | Same |
Table 1 – Comparison of Technological Characteristics
5
| | single use, disposable
device provided non-
sterile. | exposure to blood
and bodily fluids. This
is a single-use, | |
|-----------------------------|------------------------------------------------------------|------------------------------------------------------------------|-----------|
| | | disposable device(s),
provided non-sterile. | |
| Materials | | | |
| Inner Facing Layer | Spun-Bond
Polypropylene | Spun-Bond
Polypropylene | SAME |
| Middle Layer | Melt Blown
polypropylene | Melt Blown
polypropylene | SAME |
| Outer Facing Layer | Spun-bond
polypropylene | Spun-Bond
Polypropylene | SAME |
| Nose Piece | Wire, malleable
nosepiece, plastic-
coated steel | Wire, malleable
aluminum nosepiece | Different |
| Ear Loop | Polyester and
spandex materials | polyester | SAME |
| Color | Blue Outer Layer | Blue Outer Layer | SAME |
| Mask Style | Flat pleated, ear loop | Flat pleated, ear loop | SAME |
| Dimension (Width)
Adult | $9.5 cm +/-0.5cm$ | $9 cm +/-1cm$ | SIMILAR |
| Dimension (Length)
Adult | $17 cm +/-0.5cm$ | $18 cm +/- 1 cm$ | SIMILAR |
| Single Use | Yes | Yes | SAME |
| OTC Use | Yes | Yes | SAME |
| Sterility | Non-Sterile | Non-Sterile | SAME |
VII. PERFORMANCE DATA
Table 2 – Benchtop Performance Testing
| Item | Subject Device:
3 Ply Medical Grade
Single Use Procedural
Disposable Face Mask
(K220637) | Predicate Device:
Single-Use Surgical
Face Mask with Ear
Loop (K201691) | Result |
|-------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------|
| ASTM F2100 Level | II | II | PASS |
| Fluid resistance
(ASTM F1862) | 32 out of 32 pass at
120 mmHG (16.0 kPa) | 31 out of 32 pass at
120 mmHg (16.0 kPa) | PASS |
| Particulate
Filtration (ASTM
F2299) | >99.99% | > 99% | PASS |
| Bacterial Filtration
(ASTM F2101) | >99.9% | > 99% | PASS |
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| Differential
Pressure (Delta-P)
(ASTM F2100) | 8 Liters per minute
(L/min) 98% | > 99.99% |
| ASTM F2101 | Bacterial Filtration | >98% | >99.99% |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
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| ASTM F2100 | Differential Pressure
(Delta-P) |