(147 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable medical mask, with no mention of AI or ML.
No
The device is a medical mask intended for protection and infection control, not for treating or preventing disease.
No
Explanation: The device is a medical mask intended to protect against the transfer of microorganisms, not to diagnose any condition.
No
The device description clearly outlines physical components (non-woven fabric, melt blown fabric, ear loops, nose clamp) and the performance studies focus on material properties and physical tests, indicating it is a hardware device.
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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. 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, ear loops, nose clamp). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical and barrier properties of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility), not on the accuracy or reliability of a diagnostic test.
In summary, the Disposable Medical Masks described are a physical barrier device used for infection control, not a device used to perform diagnostic tests on samples outside of the body.
N/A
Intended Use / Indications for Use
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.
Product codes
FXX
Device Description
The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.
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
Non-clinical tests were conducted using 3 nonconsecutive lots with 32 samples for each model of surgical mask to verify that the proposed device met all design specifications as was same to the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted using 3 nonconsecutive lots with 32 samples for each model of surgical mask. Key results indicate that the proposed device complies with the following standards:
- Fluid Resistance, Synthetic Blood Penetration ASTM F1862: PASS (32 out of 32 passes at 160 mmHg for level 3, meeting acceptance criteria of >=29 samples out of 32 pass (AQL 4%) at 160 mmHg for level 3)
- Particulate Filtration Efficiency ASTM F2299: PASS (meeting acceptance criteria of >=98% for 29 out of 32)
- Bacterial Filtration Efficiency ASTM F2101: PASS (meeting acceptance criteria of >=98% for 29 out of 32)
- Differential Pressure (Delta P) EN 14683 Annex C: PASS (meeting acceptance criteria of = 98%.
- Bacterial Filtration Efficiency: >= 98%.
- Differential Pressure:
§ 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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September 1, 2022
Hantech Medical Device Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K221038
Trade/Device Name: Disposable Medical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2022 Received: August 29, 2022
Dear Mr. Yungvirt:
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221038
Device Name Disposable Medical Masks
Indications for Use (Describe)
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.
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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510(k) SUMMARY
I. SUBMITTER
Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi City, Ningbo City, Zhejiang Province, 315326, PEOPLE'S REPUBLIC OF CHINA Name: Arnold YANG Title: Regulatory Affairs Phone: +86 18917368988 Fax: +86 574 5899 5557 E-mail: arnoldyang@hantechmedical.com
II. Correspondent Contact Information
Bruce Cai (Contact Person) Humiss Inc. Tel: +86-13585598660 E-mail: cc401vip@126.com Summary Preparation Date: 2021.12.6
III. DEVICE
| Name of Device | Disposable Medical Masks |
|---|---|
| Models | Neo101, Neo102 |
| Common Name | SURGICAL MASK |
| Classification Name | Mask, Surgical |
| Classification | Class II |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Number | FXX |
| Review Panel: | General Hospital |
IV. PREDICATE DEVICE
Predicate Device 510k number: K211899 Predicate Device Manufacturer: Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD
V. Device Description
V1. Indications for use of the device:
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
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V2. Device Description:
The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.
| Models | Subject Device | Predicate Device
K211899 | Comparison |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Product name | Disposable Medical
Masks, Neo101,
Neo102 | SURGICAL FACE
MASK, Ear loops | Similar |
| Product code | FXX | FXX | Same |
| Regulation
number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indications for
use | The Disposable Medical
Masks are intended to
be worn to protect both
the patient and
healthcare personnel
from transfer of
microorganisms, body
fluids and particulate
material. They are
intended for use in
infection control
practices to reduce the
potential exposure to
blood and body fluids. | 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. They 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. | Same |
| Design Features | Ear Loops, Flat-pleated,
3 layers | Ear Loops, Flat-pleated, 3
layers | Same |
| Materials | | | |
| Outer layer | Non-woven fabric
(polypropylene) | Spunbond Polypropylene | Differences
resolved by
biocompatibility |
| | | | |
| Inner layer | White non-woven fabric
(polyethylene,
polyester) | Spunbond Polypropylene | Differences resolved by biocompatibility testing |
| Filter layer | Melt-blown Polypropylene | Melt-blown Polypropylene | Same |
| Nose clip (Nose clamp) | Galvanized iron wire wrapped with PE material | iron bar coated with polyolefin | Differences resolved by biocompatibility testing |
| Ear loops | Polyamide & Spandex | Spandex | Differences resolved by biocompatibility testing |
| Other Design Features | | | |
| Color | White, Blue, Purple | White | Differences resolved by biocompatibility testing |
| Dimension (Length* Width) | 17.5 x 9.5cm | (16.0cm±0.5cm) x
(11.0cm±0.5cm) | Differences resolved by performance testing |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single Use | Yes | Yes | Same |
| Sterile | No | No | Same |
| ASTM F2100 Level | Level 3 | Level 2 | Subject device demonstrates ed higher resistance to fluid penetration |
| Biocompatibility | Comply with ISO 10993-5, ISO 10993-10 | Comply with ISO 10993-5, ISO 10993-10 | Same |
VI. Predicate Comparison
Table 6 1 Surgical Eac Mock Dradionto C
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VII. Summary of Non-Clinical Test
Non-clinical tests were conducted using 3 nonconsecutive lots with 32 samples for each model of surgical mask to verify that the proposed device met all design specifications as was same to the predicate device.
The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submissions (Document issued on: March 5, 2004 and a
6
correction posted on July 14, 2004)
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- . ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
- . ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at A Known Velocity);
- EN 14683, Medical Face Masks - Requirements and Test Methods;
- . ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus:
- . ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- 16 CFR 1610, Standard for the Flammability of clothing textiles;
| Test Methodology | Purpose | Acceptance Criteria:
ASTM F2100 Level 3 | Result |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------|
| Fluid Resistance,
Synthetic Blood
Penetration ASTM
F1862 | The purpose of the test is to evaluate the Resistance to penetration by synthetic blood, Minimum pressure in mmHg | ≥29 samples out of 32 pass (AQL 4%) at 160 mmHg for level 3 | PASS
32 out of 32
passes at
160 mmHg
for level 3 |
| Particulate Filtration
Efficiency ASTM
F2299 | The purpose of the test is to evaluate the Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥ 98%
29 out of 32 pass | PASS |
| Bacterial Filtration
Efficiency ASTM
F2101 | The purpose of the test is to evaluate the Bacterial filtration efficiency (BFE) (%) | ≥ 98%
29 out of 32 pass | PASS |
| Differential Pressure
(Delta P) EN 14683
Annex C | The purpose of the test is to evaluate the Different pressure (Delta-P) |