(351 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 a face mask intended for personal protection, not for treating a disease or condition.
No
The device is described as an ear-loop face mask, intended to protect against transfer of microorganisms and body fluids. Its function is to act as a barrier, not to diagnose a medical condition.
No
The device description clearly outlines a physical product made of nonwoven materials with ear loops and a nose piece, intended for physical protection. 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 masks are for protecting against the transfer of microorganisms, body fluids, and particulate material between the patient and healthcare professional. This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection.
- Performance Studies: The performance studies focus on the mask's ability to filter particles, resist fluid penetration, and allow for breathing. These are all related to its function as a physical barrier.
- 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 used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
DEFEND Ear-loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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.
Product codes
FXX
Device Description
The DEFEND Ear-Loop Face Masks are comprised of four layers of nonwoven materials ultrasonically welded together along the edges with ear loops ultrasonically welded to the sides. The four layers include an outer layer (faces outward when worn), filtration layer, middle layer, and inner layer (faces the user).
The materials used in this mask meet the performance requirements for Level 3 stated in ASTM F2100 -19 Performance of Materials Used in Medical Face Masks. The mask is secured to the face with ear loops. The mask also includes a form-fitting pliable nose piece to improve fit and reduce gaps for maximum protection.
The DEFEND Ear-Loop Face Masks will be available in ASTM Level 3 in blue.
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 professional
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
Non-clinical performance data. Tests performed according to the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004. This includes performance testing according to ASTM F2100.
Study Type: Non-clinical performance testing
Sample Size:
- ASTM F1862: 32/32 per lot
- ASTM F2101: 32/32 per lot
- ASTM F2299: 32/32 per lot
- MIL-M-36954C or EN 14683 Annex C: 32/32 per lot
- 16 CFR Part 1610: Not specified
Key Results: All results of testing met ASTM F2100 acceptance criteria.
Key Metrics
- Fluid Resistance (ASTM F1862): 32/32 Pass per lot at 160 mmHg (Acceptance Criteria: 29/32 pass at 160 mmHg)
- Bacterial Filtration Efficiency (ASTM F2101): Average = 99.8% (Acceptance Criteria: >= 98%)
- Particulate Filtration Efficiency (ASTM F2299): Average = 99.7% (Acceptance Criteria: >= 98%)
- Breathing Resistance or Differential Pressure (MIL-M-36954C or EN 14683 Annex C): 3.4 - 4.0 mm H2O/cm^2 (Acceptance Criteria:
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure embracing a sphere. The FDA acronym is in a blue box, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text to the right of the acronym.
April 14, 2021
Young Dental Manufacturing Co. 1, LLC Jose Espino, Official Correspondent 13705 Shoreline Court East Earth City, Missouri 63045
Re: K201127
Trade/Device Name: DEFEND Ear-loop Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 6, 2021 Received: April 8, 2021
Dear Jose Espino:
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 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
1
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).
Sincerelv.
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
2
Indications for Use
510(k) Number (if known) K201127
Device Name DEFEND Ear-loop Face Masks
Indications for Use (Describe)
DEFEND Ear-loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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.
Level 3 Model: MK-7300
| 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) | ☑ |
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
Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks
510(k) Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.93, 510(k) summary is provided.
DATE: April 2, 2021
510(k) NUMBER: K201127
. SUBMITTER
Young Dental Manufacturing Co 1, LLC. 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 847-458-5829 ext. 2829 Email: jespino@younginnovations.com
ll. OFFICIAL CORRESPONDENCE/CONTACT PERSON
Jose Espino 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 847-458-5829 ext. 2829 Email: jespino@younginnovations.com
= 510(K) PREPARER
Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 314-372-8054 Email: bprange@younginnovations.com
IV. DEVICE
Brand Name of Device: DEFEND Ear-Loop Face Masks Common or Usual Name: Surgical Mask Classification Name: Mask, Surqical Regulation: 21 CFR 872.4040 Device Classification: Class: II
4
Product Code: FXX
V. PREDICATE DEVICE
Trade Name: Surgical Masks (Ear loop and Tie-on) Common Name: Surgical Mask 510(k) Number: K160269 (Decision Date: September 6, 2016) Manufacturer: San-M Package Co., LTD.
VI. DEVICE DESCRIPTION
The DEFEND Ear-Loop Face Masks are comprised of four layers of nonwoven materials ultrasonically welded together along the edges with ear loops ultrasonically welded to the sides. The four layers include an outer layer (faces outward when worn), filtration layer, middle layer, and inner layer (faces the user).
The materials used in this mask meet the performance requirements for Level 3 stated in ASTM F2100 -19 Performance of Materials Used in Medical Face Masks. The mask is secured to the face with ear loops. The mask also includes a form-fitting pliable nose piece to improve fit and reduce gaps for maximum protection.
The DEFEND Ear-Loop Face Masks will be available in ASTM Level 3 in blue. Table 1 lists the Model number of the masks that will be available.
| Table 1. DEFEND Ear-Loop Face Masks Model Number | ||
|---|---|---|
| Model Number | ASTM Level | Color |
| MK-7300 | Level 3 | Blue |
Table 1, DEEEND Ear-Loop Eace Masks Model Number
VII. INDICATIONS FOR USE
The DEFEND Ear-Loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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.
5
Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks
VIII. SUBSTANTIAL EQUIVALENCE (SE) COMPARISON
| Product Comparison - Similarities and Differences | ||||
|---|---|---|---|---|
| Characteristic | Proposed Device | San-M Package Co., | ||
| LTD., Surgical Face | ||||
| Masks (Ear loops | ||||
| and Tie-on) | Results | |||
| Manufacturer | Young Innovations | San-M Package Co., | ||
| Ltd. | ||||
| 510(k) Number | K201127 | K160269 | ||
| Class | Class II | Class II | Same | |
| Regulation Number | 21 CFR 872.4040 | 21 CFR 872.4040 | Same | |
| Intended Use / Indications for | ||||
| Use | The DEFEND Ear- | |||
| Loop Face Masks are | ||||
| intended to be worn | ||||
| to protect both the | ||||
| patient and | ||||
| healthcare | ||||
| professional 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, | ||||
| provided non-sterile. | Same | |||
| Product Code | FXX | FXX | Same | |
| Use | OTC | OTC | Same | |
| Length of Main body | 175 mm ± 5 mm | 175 mm ± 5 mm or | ||
| 180 mm ± 5 mm | Same | |||
| Width of Main body | 95 mm ± 5 mm | 90 mm ± 5 mm | Similar | |
| Mask Style | Flat-pleated | Flat-Pleated | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Colors | Blue | White or Blue | Similar | |
| Outer Material | Spunbond | |||
| Polypropylene | Polypropylene | Polypropylene | Same | |
| Filter Material | Meltblown | |||
| Polypropylene | ||||
| Fluid Resistant | ||||
| Polypropylene Film- | ||||
| Blue | Polypropylene | Polypropylene | ||
| spunbond | ||||
| Polypropylene | ||||
| meltblown | Same | |||
| Inner Material | Spunbond | |||
| Polypropylene | Polyethylene | Polyethylene | Similar | |
| Ear loops | Polyester | Polyester | Polyester, | |
| polyurethane | Same | |||
| Nose piece | Steel wire | Polyethylene coated | ||
| steel wire | Similar | |||
| Performance Testing (ASTM | ||||
| F2100-11) | ||||
| Fluid Resistance | ||||
| (ASTM F1862) | Level 3 (@ 160 | |||
| mmHg) | Pass @ 160 mmHg | Pass at 160 mmHg | Same | |
| Particulate | ||||
| Filtration | ||||
| Efficiency | ||||
| (ASTM F2299) | Level 3 (≥ 98%) | Pass @ 99.5% | Pass at 99.7% | Same |
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ||||
| (ASTM F2101) | Level 3 (≥ 98%) | Pass @ > 99% | Pass at > 99% | Same |
| Differential | ||||
| Pressure (EN | ||||
| 14683:2019, | ||||
| Annex C and | ||||
| MIL-M-36954C) | Level 3 ( |