(264 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of a face mask, with no mention of AI or ML technologies.
No.
The device is a face mask intended for infection control by protecting wearers from microorganisms, body fluids, and particulate material, not for treating a disease or condition.
No
The device is a face mask intended for protection against microorganisms and particulate matter, not for diagnosing medical conditions.
No
The device description clearly states it is a physical face mask made of 3-layer non-woven material with ear loops and a nose band. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability. There is no mention of software components or 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 by being worn. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and filtration capabilities of the mask material.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility), not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The LAITEST Surgical Face Mask 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users.
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
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 performed on the proposed device, conforming to the standards and requirements in the "Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission" issued on March 5, 2004.
Studies performed include:
- Fluid Resistance Performance (ASTM F1862): Determined synthetic blood penetration resistance. Result: Pass (>=29 of 32 pass at 120 mmHg).
- Particulate Filtration Efficiency (ASTM F2299): Determined bacterial filtration efficiency. Result: Pass (>98%).
- Bacterial Filtration Efficiency (ASTM F2101): Determined submicron particulate filtration efficiency. Result: Pass (>98%).
- Differential Pressure (Delta P) (EN 14683): Determined breathing resistance or differential pressure. Result: Pass ( 98%
Particle Filtration Efficiency (PFE): > 98%
Virus Filtration Efficiency (VFE): 99%
Fluid Resistance: >=29 of 32 pass at 120 mmHg
Differential Pressure (Delta P):
§ 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). 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.
September 13, 2022
R&R Medical Corporation Ltd. % Chih-Hao Kao Vice President Voler Biotech Consulting Co., Ltd. No. 3-1, Lane 58, Hejiang St., Zhongshan Dist. Taipei City, 10480 Taiwan
Re: K214035
Trade/Device Name: LAITEST Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 23, 2022 Received: August 31, 2022
Dear Chih-Hao Kao:
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, 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) K214035
Device Name LAITEST MEDICAL FACE MASK
Indications for Use (Describe)
The LAITEST MEDICAL FACE MASK 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Type of Use (Select one or both, as applicable)
| Production Use: Part 21 CFR 601.2, Subpart E |
|---|
| Compassionate Use: Part 21 CFR 601.2, Subpart I |
| | 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
[As required by 21 CFR 807.92]
1. Submission Information
| Preparation date: | August 23th, 2022 |
|---|---|
| Submitter: | R&R Medical Corporation Ltd. |
| No.4, Ln. 38, Zhongxing N. St., Sanchong Dist., New Taipei | |
| City 24158, Taiwan (R.O.C.) | |
| Submitter contact: | Wilson Chang |
| Tel: +886-2-2697-6618/Fax: +886-2-2697-6609 | |
| E-mail: wcchang@taiwanstanch.com | |
| Official correspondent: | Chih Hao, Kao |
| Tel: + 886-933852972/Fax: + 886-78419003 | |
| E-mail: leon.howard01@gmail.com |
2. Device Name and Classification
| Product Name: | LAITEST Surgical Face Mask |
|---|---|
| Classification Name: | Mask, Surgical |
| Common or Usual Name: | Surgical face mask |
| Regulation medical specialty: | General & Plastic Surgery |
| Regulation Description: | Surgical apparel. |
| Review Panel: | General Hospital |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class 2 |
| Product Code: | FXX |
3. Primary Predicate Device(s)
| Product Name: | Surgical Face Mask (K182515) |
|---|---|
| Classification: | Class II |
| Common or Usual Name: | Surgical face mask |
| Classification Panel: | Surgical Apparel |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class 2 |
| Product Code: | FXX |
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4. Device Description
LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users.
5. Indications for Use
The LAITEST 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(s), provided non-sterile.
5
6. Substantial Equivalence
| | Proposed Device | Primary predicate
device
K182515 | Differences | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------|
| Item | LAITEST Surgical
Face Mask | Surgical Face Mask | NA | |
| Classification | 2
(21CFR878.4040) | 2
(21CFR878.4040) | Same Classification | |
| Product Code | FXX | FXX | Same Product Code | |
| Indications for Use | The LAITEST
Surgical Face Mask
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. | 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. | Both devices are
surgical face mask
and have same
intended use. | |
| Basic design | Ear Loops, Flat
Pleated, 3 layers | Ear Loops, Flat
Pleated, 3 layers | Same | |
| | | Proposed Device | Primary predicate
device
K182515 | Differences |
| Item | | LAITEST Surgical
Face Mask | Surgical Face Mask | NA |
| | External
layer | Spun-bond
polypropylene | Spun-bond
polypropylene | Same |
| Material | Filter
layer | Melt blown filter | Melt blown
polypropylene filter | Same |
| | Inner
layer | Spun-bond
polypropylene | Spun-bond
polypropylene | Same |
| Nose band | | PE coating Aluminum
Line | Malleable
polyethylene wire | Different |
| Ear loops | | Nylon + Spandex | Spandex | Similar |
| | Color | Blue | Yellow | Different |
| Dimension-Width | | 17.5 cm ± 5% cm
(0.875 cm) | 17.5cm±0.2cm | Similar |
| Dimension-Length | | 9.5 cm±5% cm
(0.475 cm) | 9.5cm±0.2cm | Similar |
| OTC use | | Yes | Yes | Same |
| | Sterility | Non-Sterile | Non-Sterile | Same |
| Use | | Single Use,
Disposable | Single Use,
Disposable | Same |
| | ASTM F2100 Level | Level 2 | Level 2 | Same |
6
7
Performance Data
Non-clinical Test performed on the proposed device
The proposed devices were 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.
| Item | Purpose | Proposed device | Acceptance
Criteria | Result |
|-------------------------------------------------------|------------------------------------------------------------------------|-------------------------------|-------------------------------|--------|
| Fluid
Resistance
Performance
ASTM F1862 | Determine
synthetic
blood
penetration
resistance | ≥29 of 32 pass at
120 mmHg | ≥29 of 32 pass at
120 mmHg | Pass |
| Particulate
Filtration
Efficiency
ASTM F2299 | Determine the
bacterial
filtration
efficiency | > 98% | ≥ 98% | Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | Determine
submicron
particulate
filtration
efficiency | > 98% | ≥ 98% | Pass |
| Differential
Pressure
(Delta P)
EN 14683 | Determine
breathing
resistance
Or
differential
pressure |