(156 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a face mask, with no mention of AI or ML.
No
The device is described as a face mask intended for infection control, protecting against the transfer of microorganisms, body fluids, and particulate material. It is not described as treating or alleviating a disease or condition.
No
Explanation: The provided text describes the device as a face mask intended for protection from microorganisms and fluids, used in infection control practices. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines a physical product composed of nonwoven materials, tie strings or ear loops, and a malleable nosepiece. The performance studies listed are for physical properties like filtration efficiency, resistance to penetration, and flammability, not software performance.
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 masks are for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. 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 of the mask (layers of nonwoven material, ear loops/ties, nosepiece, etc.). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies listed focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility). These are relevant to a protective device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This face mask does not fit that description.
N/A
Intended Use / Indications for Use
The Medline Surgical Face Mask and Medline Procedural Face Mask are intended to be worn to protect both the patient and the healthcare worker from the 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. These masks are single use, disposable, non-sterile devices.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Medline Surgical Face Mask and Medline Procedural Face Mask are single-use, disposable device, provided non-sterile. Depending on the configurations, the Medline Surgical Face Mask and Medline Procedural Face Mask are composed of three or four layers of nonwoven materials: an outer layer, middle filtration layer(s) and an inner facing layer. The outer/inner facing layers are constructed of non-woven fabric and the middle filtration layer(s) are constructed of melt blown non-woven fabric.
Each mask contains tie strings or ear loops to secure the user's face and mouth, and come in a flat pleated style that includes a malleable nosepiece to provide a firm fit over the nose. The Medline Surgical Face Mask and Medline Procedural Face Mask may also come equipped with an antifog foam stripe, anti-glare stripe and/or a face shield to cover the upper part of the face. The Medline Surgical Face Mask and Medline Procedural Face Mask may also be provided in an ASTM Fluid level of Level 1, Level 2 or Level 3. The color of the facemasks will be available in white, yellow, blue, or pink stripes.
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 worker
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 performance testing was completed on the Medline Surgical Face Mask and Medline Procedural Face Mask to demonstrate the safety and effectiveness of the subject device with the relevant test methods described in Table 2 below.
Table 2. Non-Clinical Performance Testing Standards:
- ISO 10993-5: ISO MEM Elution Using L-929 Mouse Fibroblast Cells
- ISO 10993-10: Repeated Patch Dermal Sensitization Test
- ISO 10993-10: ISO Intracutaneous Irritation Test
- ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- ASTM F2101-19: Bacterial filtration efficiency (BFE)
- ASTM F1862: Resistance to penetration by synthetic blood
- 16 CFR Part 1610: Standard for the Flammability of Clothing
- ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
- EN 14683:2019: Differential Pressure (Delta-P)
- ASTM F2299: Sub-micron particulate filtration efficiency (PFE)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
March 24, 2023
Medline Industries, LP Kelsey Closen Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K223236
Trade/Device Name: Medline Surgical Face Mask and Medline Procedural Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 3, 2023 Received: February 22, 2023
Dear Kelsey Closen:
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,
Katherine D. Kavlock -S
for
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) K223236
Device Name
Medline Surgical Face Mask and Medline Procedural Face Mask
Indications for Use (Describe)
The Medline Surgical Face Mask and Medline Procedural Face Mask are intended to be worn to protect both the patient and the healthcare worker from the 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. These masks are single use, disposable, non-sterile devices.
Type of Use (Select one or both, as applicable)
| Recreational Use (Part 91, CFR 90.1 Subpart D) |
|---|
| Commercial Use (91 CFR 90.1 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K223236 Page 1 of 4
Image /page/3/Picture/1 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst or cross-like symbol. The symbol is white, creating a strong contrast against the blue, and it appears to be a central element of the logo's design.
Medline Industries, LP Three Lakes Drive Northfield. IL 60093
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Contact Person: Kelsey Closen, Regulatory Affairs Specialist Phone: 847-949-2283 Email: KClosen@medline.com
Summary Preparation Date October 7, 2022
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline Surgical Face Mask and Medline Procedural Face Mask Common Name: Surgical Mask Classification Name: Mask, Surgical Product Code: FXX Classification Panel: Orthopedic Regulatory Class: II Regulation Number: 21 CFR 878.4040
Predicate Device
K202598: Surgical Masks with Ear Loops or Ties, Level 1, Level 2, Level 3
Device Description
The Medline Surgical Face Mask and Medline Procedural Face Mask are single-use, disposable device, provided non-sterile. Depending on the configurations, the Medline Surgical Face Mask and Medline Procedural Face Mask are composed of three or four layers of nonwoven materials: an outer layer, middle filtration layer(s) and an inner facing layer. The outer/inner facing layers are constructed of non-woven fabric and the middle filtration layer(s) are constructed of melt blown non-woven fabric.
4
Image /page/4/Picture/1 description: The image features the Medline logo, which is set against a blue square background. The word "MEDLINE" is written in white, bold, sans-serif letters. A white, stylized starburst or cross-like symbol is positioned behind the text, with its center aligned with the middle of the word. A gray bar is located in the upper right corner of the image.
Aedline Industries. Three Lakes Drive Northfield, IL 60093
Each mask contains tie strings or ear loops to secure the user's face and mouth, and come in a flat pleated style that includes a malleable nosepiece to provide a firm fit over the nose. The Medline Surgical Face Mask and Medline Procedural Face Mask may also come equipped with an antifog foam stripe, anti-glare stripe and/or a face shield to cover the upper part of the face. The Medline Surgical Face Mask and Medline Procedural Face Mask may also be provided in an ASTM Fluid level of Level 1, Level 2 or Level 3. The color of the facemasks will be available in white, yellow, blue, or pink stripes.
Indications for Use
The Medline Surgical Face Mask and Medline Procedural Face Mask is intended to be worn to protect both the patient and the healthcare worker from the 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. These masks are single use, disposable, non-sterile devices.
Summary of Technological Characteristics
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Medline Surgical Face Mask and Medline
Procedural Face Mask | Surgical Masks with Ear Loops or Ties, Level 1,
Level 2, Level 3 | N/A |
| 510(k)
Reference | TBD | K202598 | N/A |
| Product Owner | Medline Industries LP | 3A Medical Products Co., Ltd | N/A |
| Regulation
Number | 878.4040 | 878.4040 | Same |
| Product Code | FXX | FXX | Same |
| Intended Use | This mask is intended to be worn to
protect both the patient and the healthcare
worker from the 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. These masks are
single use, disposable, non-sterile devices | This mask is intended to be worn to protect both
the patient and healthcare worker from the transfer
of microorganisms, body fluids and Particulate
material. This mask is intended for use in infection
control practices to reduce the potential exposure
to blood and body fluids. This is a single use
device provided nonsterile. | Same |
| Design Features | Pleated
Nose Piece | Pleated
Nose Piece | Similar-
Additionally |
| | Face Shield | Ties | Medline offers the
facemask in a face
shield, anti-glare
and anti- fog style.
There are no safety
or risk concern with
these optional
features. |
| | Anti-glare strip | Ear loops | |
| | Anti-fog foam strip | | |
| | Ties | | |
| | Ear loops | | |
| Color
Configurations | | | Similar – Medline
offers the facemasks
in more colors.
There is no safety or
risk concern with
the additional colors
based on
biocompatibility
testing |
| | Blue | | |
| | Yellow | Blue | |
| | White | | |
| | Pink Stripe | | |
| Materials | Face Mask: | | Similar – Medline
offers more fabric
variations but there
is no safety or risk
concern based on
performance and
biocompatibility
testing |
| | 1. Spunbond/Meltblown/Spunbond | | |
| | 2. Cellulose/Meltblown/Spunbond | | |
| | 3. Cellulose/Meltblown/Cellulose | | |
| | 4. Cellulose/Meltblown
Spunbond/Cellulose | Face Mask:
- Polypropylene/Spunbond/Polypropylene
- Polypropylene/Meltblown/Polypropylene | |
| | 5. Thermalbond/Meltblown/Spunbond | | |
| | Ear Loops: | Ear Loops: - Polyester/Spandex | |
| | 1. PP& Lycra - Polyester & Spandex
- Polypropylene
- Polyester, Spandex & Urethane | | |
| | Ties: - PP | Ties:
- Polypropylene Spunbond | |
| | Nose Strip: - HDPE, Paper, Wire
- Polypropylene & iron
- Aluminum
- Iron & PE
- Steel & PE | Nose Strip :
- Polyethylene coated Steel Wire | |
| Prescription vs.
OTC | OTC | OTC | Same |
5
Image /page/5/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white graphic. The graphic resembles a starburst or a stylized medical symbol, with sharp, angular lines converging towards a central point.
Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093
K223236 Page 3 of 4
6
Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white starburst or lightning bolt symbol positioned vertically behind the text. The background is a solid dark blue color. The logo is simple and modern, with a clean design.
Sterile vs. Non-Same Non-Sterile Non-Sterile Sterile Disposable vs. Same Disposable Disposable Non-Disposable Same Single Use vs. Single Use Single Use Reusable ASTM F2100 Same Level 1, 2, 3 Level 1, 2, 3 Level
Summary of Non-Clinical Testing
Non-clinical performance testing was completed on the Medline Surgical Face Mask and Medline Procedural Face Mask to demonstrate the safety and effectiveness of the subject device with the relevant test methods described in Table 2 below.
| ISO 10993-5 | ISO MEM Elution Using L-929 Mouse Fibroblast Cells |
|---|---|
| ISO 10993-10 | Repeated Patch Dermal Sensitization Test |
| ISO 10993-10 | ISO Intracutaneous Irritation Test |
| ISO 10993-1 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process |
| ASTM F2101-19 | Bacterial filtration efficiency (BFE) |
| ASTM F1862 | Resistance to penetration by synthetic blood |
| 16 CFR Part 1610 | Standard for the Flammability of Clothing |
| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical Face Masks |
| EN 14683:2019 | Differential Pressure (Delta-P) |
| ASTM F2299 | Sub-micron particulate filtration efficiency (PFE) |
Table 2. Non-Clinical Performance Testing Standards
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Summary of Clinical Testing
Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, LP. concludes that the Medline Surgical Face Mask and Medline Procedural Face Mask are as safe and as effective for their intended use as the predicate device, Surgical Masks with Ear Loops or Ties, Level 1, Level 2, Level 3 (K202598).