(109 days)
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a standard face mask, with no mention of AI or ML.
No.
This device is designed to prevent the transfer of microorganisms and body fluids, acting as a barrier, rather than directly treating or curing a medical condition.
No
The device description and intended use clearly state that face masks are used to protect individuals from the transfer of microorganisms by being worn, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt-blown polypropylene, ear loops, iron wire nose piece) and the performance studies focus on material properties and physical barriers, 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 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 in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask, consistent with a barrier device.
- Performance Studies: The performance studies focus on the physical and biological barrier properties of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility), not on analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would lead to a diagnosis or provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens from the human body 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 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. The Face Masks are single use, disposable devices, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (Iron wire covered by polypropylene) to provide a firm fit over the nose.
There are two models for Face Mask with different colors and sizes.
For Type A model is in blue, barrier level 2 and size 145mm95mm, ear loop type.
For Type B model is in blue, barrier level 2 and size 175mm95mm, ear loop type.
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
Not Found
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 conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Face Masks complies with the following standards:
- ASTM F2100-19 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 14683:2019+AC2019(E) Annex C .
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of . Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101 Standard Method for Evaluating the Bacterial Filtration . Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- MIL-M- 36954C Military Specification, Mask, Surgical, Disposable ●
- 16 CFR Part 1610 Standard for the Flammability of Clothing ●
- ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process
- . ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices
- ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance ASTM F1862: 32 out of 32 pass at 120mmHg
- Particulate Filtration Efficiency (PFE) ASTM F2299: Pass at 99.70%
- Bacterial Filtration Efficiency (BFE) ASTM F2101: Pass at 99.95%
- Differential Pressure (Delta P)MIL-M-36954C: Pass at 3.0 mmH2O/cm^2
- Flammability 16 CFR PART 1610: Class 1 Non-Flammable
- Cytotoxicity: Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.
- Irritation: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.
- Sensitization: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing
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.
K202491, Model: EL-M02 and EL-L02 Level 2
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 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.
April 23, 2021
Jinhua Jingdi Medical Supplies Co., Ltd % Julie Chen RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shangha, 200040 China
Re: K210007
Trade/Device Name: Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 4, 2021 Received: March 8, 2021
Dear Julie Chen:
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,
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) K210007
Device Name Face Mask
Indications for Use (Describe)
The 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. The Face Masks are single use, disposable devices, 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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3
510(K) Summary - K210007
I. SUBMITTER:
Jinhua Jingdi Medical Supplies Co.,Ltd Building 2, Ditian Function, Xiaoshun Town, JindongZone, Jinhua City, Zhejiang, China Contact Person: Hu Xiaojiang Title: Quality Manager Tel: +86 13989428215 Email: xiaojianghu@jhjingdi.com
Submission Correspondent: Julie Chen Email: julie.chen(@mind-link.net Tel:+86 13918045781
Summary prepared: 12/04/2020
II. DEVICE
Name of Device: Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX
III. PREDICATE DEVICE
Primary predicate device: Surgical Face Masks (K182514)
IV. REFERENCE DEVICE
Reference device: Disposable Surgical Face Mask (K202491, Model: EL-M02 and EL-L02 Level 2)
4
V. DEVICE DESCRIPTION
Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (Iron wire covered by polypropylene) to provide a firm fit over the nose.
There are two models for Face Mask with different colors and sizes.
For Type A model is in blue, barrier level 2 and size 145mm95mm, ear loop type. For Type B model is in blue, barrier level 2 and size 175mm95mm, ear loop type.
VI. INDICATIONS FOR USE
The 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. The Face Masks are single use, disposable device, provided non-sterile.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. THE PREDICATE DEVICE
The Face Masks are compared with the predicate device (Surgical Face Masks (K182514)). The results are shown below in the Technological Characteristics Comparison Table:
| DEVICE | Subject Device Face
Mask | Primary Predicate Device
Surgical Face Mask
(K182514) | Reference Device
Disposable Surgical Face
Mask
(K202491, Level 2) | Remark |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Intended Use | The 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 | 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 | The Disposable 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 | Same |
| | to reduce the potential
exposure to blood and
body fluids. The Face
Masks are single use,
disposable device,
provided non-sterile. | infection control practices
to reduce the potential
exposure to blood and
body fluids. This is a
single-use, disposable
device, provided non-
sterile. | to reduce the potential
exposure to blood and
body fluids. The Disposable
Surgical Face Masks are
single use, disposable
devices, provided non-sterile. | |
| Classification | FXX | FXX | FXX | Same |
| Product Code | | | | |
| Ear Loop
Model | Ear Loops | Ear Loops | Ear Loops | Same |
| | | Materials | | |
| Outer Facing
Layer | Spun-bond polypropylene
non-woven fabric | Spun-bond polypropylene | Spun-bond Polypropylene
non-woven fabric | Similar
Note 1 |
| Middle Layer | Melt-blown
polypropylene | Melt blown polypropylene
filter | Melt blown polypropylene | Similar
Note 1 |
| Inner Facing
Layer | Spun-bond polypropylene
non-woven fabric | Spun-bond polypropylene | Spun-bond polypropylene
non-woven fabric | Similar
Note 1 |
| Nose Piece | Iron wire
covered
polypropylene | Malleable aluminum wire | Malleable iron wire with
plastic covering | Similar
Note 1 |
| Ear Loops | 75%Polyamie
25% Spandex | Polyester | Spandex Elastic cord | Similar
Note 1 |
| | | Design Features | | |
| Color | Blue | White | Blue | Different
Note 1 |
| Style | Flat - Pleated | Flat - Pleated | Flat - Pleated | Same |
| Multiple
Layers | 3 Layers | 3 Layers | 3 Layers | Same |
| Single Use | Single use | Single use | Single use | Same |
| | | Sterility | | |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| | | Dimensions | | |
| Length ×
Width | 145×95mm(±5mm)
175×95mm (±5mm) | 175×95mm(±10mm) | 145×95mm (±5mm)
175×95mm (±5mm) | Different
Note 2 |
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 - Meets Level 2 | | | | |
| Fluid
Resistance
ASTM F1862 | 32 out of 32 pass at
120mmHg | 32 out of 32 pass at
120mmHg | Pass at 120mmHg | Same |
| Particulate
Filtration
Efficiency
(PFE) | Pass at 99.70% | Pass at 99.88% | Pass at >99.8% | Same |
| ASTM F2299 | | | | |
| Bacterial
Filtration
Efficiency
(BFE)
ASTM F2101 | Pass at 99.95% | Pass at 99.6% | Pass at $\ge$ 99.8% | Same |
| Differential
Pressure
(Delta P)MIL-
M-36954C | Pass at $3.0 mmH_2O/cm^2$ | Pass at $3.0 mmH_2O/cm^2$ | Pass at $