(135 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard face mask, with no mention of AI or ML.
No
The device is a surgical mask intended for infection control, not for treating or diagnosing a disease or condition.
No
The device description clearly states its purpose is to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly outlines a physical, multi-layered mask with specific material components (polypropylene, polyester, polyurethane, polyethylene) and physical features (ear loops, nose piece). The performance studies focus on bench testing of physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware devices, not software.
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 over the mouth and nose. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of a mask, not a device designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, breathability, flammability, biocompatibility) related to its barrier function. They do not involve analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, assays, or diagnostic algorithms described.
In summary, the device is a physical barrier intended for infection control, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene.
The proposed device is provided non-sterile and is intended to be a single use, disposable device.
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
Adult use
Intended User / Care Setting
Healthcare personnel, infection control practices
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)
Biocompatibility testing:
- In vitro Cytotoxicity (ISO 10993-5): Pass, The extract is non-cytotoxic under the research conditions.
- Skin Irritation (ISO 10993-10): Pass, The polar and non-polar extracts are non-irritating under the research conditions.
- Skin Sensitization (ISO 10993-10): Pass, The polar and non-polar extracts are non-sensitizing under the research conditions.
Performance testing - Bench:
- Fluid Resistance (ASTM F1862): 96 out of 96 pass at 160 mmHg, meets Level 3 requirements.
- Bacterial filtration efficiency (BFE) (ASTM F2101): 99.8%~>99.9% (Average: ≥99.9%), meets Level 3 requirements (≥98%).
- Particulate filtration efficiency (PFE) (ASTM F2299): 99.0%~99.8% (Average: 99.6%), meets Level 3 requirements (≥98%).
- Differential pressure (Delta-P) (EN 14683): (2.8~4.5) mmH2O/cm² (Average: 3.7 mmH2O/cm²), meets Level 3 requirements (99.9% (Average: ≥99.9%)
- Particulate filtration efficiency (PFE): 99.0%~99.8% (Average: 99.6%)
- Differential pressure (Delta-P): (2.8~4.5) mmH2O/cm² (Average: 3.7 mmH2O/cm²)
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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December 15, 2021
Hubei Kimsoul Industrial Co., Ltd Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K212398
Trade/Device Name: Surgical Face Mask (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 16, 2021 Received: Nov 1, 2021
Dear Grace Liu:
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.
1
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 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.
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212398
Device Name Surgical Face Mask (Non-sterile)
Indications for Use (Describe)
The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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.
| 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
Product: Surgical Face Mask (Non-sterile)
Version: A/0
510(k) Summary
K212398
1. Contact Details
- 1.1 Applicant information
| Applicant Name | HUBEI KIMSOUL INDUSTRIAL CO., LTD |
|---|---|
| Address | NO. 1, Industrial Zone, Guohe Town, Xiantao City, Hubei |
| Province, China | |
| Contact person | Faming Zhang |
| Phone No. | +86-177 0727 3453 |
| zhangfaming@ks-nonwoven.com.cn | |
| Date Prepared | 2021-10-16 |
1.2 Submission Correspondent
| Image: Logo | Shenzhen Joyantech Consulting Co., Ltd
1713A, 17th Floor, Block A, Zhongguan Times Square,
Nanshan District, Shenzhen, Guangdong Province, China |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 卓 远 天 成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Surgical Face Mask (Non-sterile) |
|---|---|
| Common name | Surgical Face Mask |
| Model | 2020, 2030 |
| Classification | II |
| Classification name | Mask, Surgical |
| Product code | FXX |
| Regulation No. | 21 CFR 878.4040 |
3. Legally Marketed Predicate Device
| Trade Name | Ear-Friendly Mask |
|---|---|
| 510(k) Number | K211105 |
| Product Code | FXX |
| Manufacturer | RAY Co., Ltd |
4. Legally Marketed Reference Device
Trade Name Disposable Surgical Mask
4
| Version: A/0 | |
|---|---|
| 510(k) Number | K202341 |
|---|---|
| Product Code | FXX |
| Manufacturer | Shanghai Jianzhong Medical Packaging Co., Ltd. |
5. Device Description
The proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene.
The proposed device is provided non-sterile and is intended to be a single use, disposable device.
6. Intended Use/Indication for Use
The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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.
7. Technological Characteristics Comparison
| Item | Proposed Device
(K212398) | Predicate Device
(K211105) | Reference Device
(K202341) | Comment |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product name | Surgical Face Mask
(Non-sterile) | Ear-Friendly Mask | Disposable Surgical Mask | / |
| Manufacturer | HUBEI KIMSOUL
INDUSTRIAL CO., LTD | RAY Co., Ltd | Shanghai Jianzhong
Medical Packaging Co.,
Ltd. | / |
| Product Code | FXX | FXX | FXX | Same |
| Regulation
Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Class II | Same |
| OTC use | Yes | Yes | Yes | Same |
| ASTM Level | Level 3 | Level 3 | Level 3 | Same |
| Indications for
use | The masks are intended to
be worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate | When properly worn, the
Ear-Friendly Masks are
intended to protect both
patient and healthcare
workers from transfer of
microorganisms, body | The Disposable Surgical
Masks are intended to be
worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body | Similar |
| | material. These masks are
intended for adult 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. | fluids and particulate
material. This device is non
sterile and for single use
only. | 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 and sterile.
Models:
17.59.5cm-3ply (sterile),
14.59.5cm-3ply (sterile),
14.58cm-3ply (sterile)
17.59.5cm-3ply
(non-sterile),
14.59.5cm-3ply
(non-sterile),
14.58cm-3ply (non-sterile) | |
| Design
feature | Ear-loop | Ear-loop | Ear-loop | Same |
| Mask style | 3-ply, Flat Pleated | 3-ply, Flat Pleated | 3-ply, Flat Pleated | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Single Use, Disposable | Same |
| Color | White | White | Blue | Same |
| Specifications
and
Dimensions | 2020:
(145±5) mm x (95±5) mm
2030:
(175±5) mm x (95±5) mm | Length: (175±10) mm
Width: (95±10) mm | 17.59.5 cm
14.59.5 cm
14.5*8 cm | Different |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile, Sterile | Same |
| Materials | | | | |
| Outer layer | Spunbond polypropylene | Spunbond polypropylene | Polypropylene | Same |
| Middle layer | Meltblown polypropylene
filter | Meltblown polypropylene
filter | Polypropylene melt-blown | Same |
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Polypropylene | Same |
| Nose piece | Polyethylene (PE) | Single Galvanize wire,
coated By PE | Polyvinylchloride coated
iron wire | Different |
| Ear loop | Polyester and
Polyurethane | Elastic non-woven Fabric
(Made With PE&PP mixed) | Polyurethane | Different |
| Performance | | | | |
| Resistance | | | | |
| Bacterial
Filtration
Efficiency | Pass at ≥98% | Pass at ≥98% | Pass at >98.12% | Same |
| Particulate
Filtration
Efficiency | Pass at ≥98% | Pass at ≥98% | Pass at >98.01% | Same |
| Differential
Pressure
(Delta-P) | Pass at ASTM F2100-20 Standard Specification for Performance of Materials Used in Medical Face Masks
-
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
-
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
ASTM F2299/F2299M-03 (R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
-
EN 14683:2019+AC:2019 Medical Face Masks - Requirements and Test Methods
-
16 CFR 1610 Standard for the Flammability of Clothing Textiles
| Test | Purpose | Acceptance Criteria
per ASTM
F2100-20
(AQL=4.0%) | Results
(Statistics of three lots, 32
per lot) |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------|
| Fluid
Resistance
(ASTM F1862) | Verify the fluid resistance of
the proposed device can meet
the requirements for Level 3
specified in ASTM F2100-20. | Pass at 160 mmHg | 96 out of 96 pass at 160
mmHg |
| Bacterial
filtration
efficiency (BFE)
(ASTM F2101) | Verify the bacterial filtration
efficiency of the proposed
device can meet the
requirements for Level 3
specified in ASTM F2100-20. | ≥98% | 99.8%~>99.9%
(Average: ≥99.9%) |
| Particulate
filtration
efficiency (PFE)
(ASTM F2299) | Verify the particulate filtration
efficiency of the proposed
device can meet the
requirements for Level 3
specified in ASTM F2100-20. | ≥98% | 99.0%~99.8%
(Average: 99.6%) |
| Differential
pressure
(Delta-P) | Verify the differential pressure
of the proposed device can
meet the requirements for |