(138 days)
Not Found
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
A therapeutic device is used to treat or cure a disease or condition. This device is described as a mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, which is a preventive measure, not a treatment.
No
The device is a medical mask designed to protect against the transfer of microorganisms and fluids, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical, multi-layered mask with ear loops and a nose piece, made of materials like polypropylene and aluminum wire. It is a tangible hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the wearer and others from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical construction and materials of a mask. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the mask's filtration efficiency, breathability, fluid resistance, and flammability. These are all related to its function as a physical barrier, not its ability to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This mask does not fit that definition.
N/A
Intended Use / Indications for Use
The Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. It 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 Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device.
This product contains no components made from natural rubber latex.
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)
Performance testing was provided to validate and verify that the Disposable Medical Mask, non-sterile, earloop met all requirements of related international standards, including biocompatibility and product specifications. These tests' results demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing:
Bacterial Filtration Efficiency (BFE, %): Average 99.79% (Pass)
Particulate Filtration Efficiency (PFE, at 0.1µm, %): Average 99.13% (Pass)
Differential Pressure (Delta P, mm H2O/cm2): 4.4mm H2O/cm² (Pass)
Resistance to penetration by synthetic blood: 31 of 32 pass at 120 mmHg (Pass)
Flame Spread: Class 1 Non-Flammable (Pass)
Biocompatibility Testing:
The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: The subject device is classified as a surface device and contact intact skin for limited contact duration. The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device.
In Vitro Cytotoxicity (ISO10993-5: 2009): Following the standard's defined conditions, the device is non-cytotoxic. (Pass)
Skin Sensitization (ISO10993-10: 2010): Following the standard's defined conditions, the device is non-sensitizing. (Pass)
Skin Irritation (ISO10993-10): Following the standard's defined conditions, the device is non-irritating. (Pass)
Clinical Test:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency (BFE, %): Average 99.79%
Particulate Filtration Efficiency (PFE, at 0.1µm, %): Average 99.13%
Differential Pressure (Delta P, mm H2O/cm2): 4.4 mm H2O/cm²
Resistance to penetration by synthetic blood: 31 out of 32 pass at 120mmHg
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.
Not Found
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 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.
January 19, 2022
Jiangsu Nanfang Medical Co., Ltd. Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K212826
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 17, 2021 Received: December 21, 2021
Dear Charles Mack:
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 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.
For Clarence W. Murray, III, Ph.D. 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)
Device Name Disposable Medical Mask
Indications for Use (Describe)
The Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use (Part 1, CFR 201, Subpart D) | On-The-Go-Grant Use (Part 1, CFR 201, Subpart J) |
|---|---|
| ------------------------------------------------------------ | ---------------------------------------------------------------- |
| | 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 K212826
I. Submitter Information
Preparation Date: January 7, 2022 Manufacturer's Name and Address: Jiangsu Nanfang Medical Co., Ltd. No.1 Guoxiang RD, Wujin Economic Development Zone, Wujin, Changzhou City, Jiangsu Province, CHINA213149 Mrs. Li Xia Sales Director Tel: 86-519-86362198 Email: singerli@nanfangmedical.com FDA Establishment Registration No.: 9710583 Designated IRC USA Submission Correspondent 2950 E Lindrick Dr., Chandler, and US Agent: Arizona 85249, USA Mr. Charles Mack Principal Engineer Tel: 931-6254938 Email: charliemack@irc-us.com Telephone Number: 931-625-4938 Email Address: charliemack@irc-us.com Trade Name: Disposable Medical Mask Device Disposable Medical Mask Common Name(s): Regulation Name(s): mask, surgical
21CFR878.4040
FXX
Class II
Device Class:
Product Code:
II.
III. Predicate Device:
Regulation Number(s):
Xiantao Rayxin Medical Products Co., Ltd. Disposable Surgical Face Mask K153496
4
IV. Device Description:
The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device.
This product contains no components made from natural rubber latex.
V. Indications for Use
The Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s), provided non-sterile.
5
VI. Comparison of Technological Characteristics with the Predicate Device
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device | Disposable Medical Mask | Disposable Surgical Face Mask | - |
| Model | Ear Loop | Ear Loop and Tie-On | - |
| 510(k) | K212826 | K153496 | - |
| Indication for Use | The Disposable Medical Mask is intended to be | ||
| worn to protect both the patient and healthcare | |||
| personnel from transfer of microorganisms, body | |||
| fluids and particulate material. It is intended for use | |||
| in infection control practices to reduce the potential | |||
| exposure to blood and body fluids. It is a single-use, | |||
| disposable device(s), provided non-sterile. | The Disposable 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. | Identical | ||
| OTC or | |||
| Prescription | OTC | OTC | Identical |
| Product Code | FXX | FXX | Identical |
| Classification | Class 2, CFR878.4040 | Class 2, CFR878.4040 | Identical |
| Material: | |||
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Identical |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Identical |
| Earloop | Polyurethane + Polyester | Polyester | Note 1 |
| Colorant | Polypropylene (PP) master batch | Polypropylene (PP) master batch | Identical |
| Design features | Color: Blue | Color: Blue | Identical |
| Ear Loop | Ear Loop | Identical | |
| Mask Style | Flat Pleated | Flat Pleated | Identical |
| Specification | |||
| and Dimension | Length: 17.5 cm ± 1 cm | Length: 17.5cm±1cm | Identical |
| Width: 9.5 cm ± 1 cm | Width: 9.5cm±1cm | Identical | |
| Sterility | Non-sterile | Non-sterile | Identical |
| Usage | Disposable, Single Use | Disposable, Single Use | Identical |
6
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Performance: | |||
| Performance | |||
| Testing (ASTM | |||
| F2100-19) | Level 2 | Level 2 | Identical |
| Fluid Resistance | |||
| Performance | |||
| ASTM F1862 | 31 out of 32 pass at 120mmHg | 32 out of 32 pass at 120mmHg | Note 2 |
| Particulate | |||
| Filtration | |||
| Efficiency ASTM | |||
| F2299 | Average 99.13% | Average 98.46% | |
| Bacterial Filtration | |||
| Efficiency ASTM | |||
| F2101 | Average 99.79% | Average 98.70% | |
| Differential | |||
| Pressure (Delta | |||
| P) EN 14683:2019, | |||
| Annex C | 4.4 mm H2O/cm² | 4.2 mm H2O/cm² | |
| Flammability 16 | |||
| CFR 1610 | Class 1 | ||
| Non Flammable | Class 1 | ||
| Non Flammable | Identical | ||
| Biocompatibility | Complied with ISO10993-1 | Complied with ISO10993-1 | Identical |
| Cytotoxicity (ISO | |||
| 10993-5) | Under the conditions of the study, not cytotoxic. | ||
| Complies with ISO-10993-5. | Under the conditions of the study, not cytotoxicity effect | Identical | |
| Sensitization (ISO | |||
| 10993-10) | Under conditions of the study, not a sensitizer. | ||
| Complies with ISO-10993-10. | Under conditions of the study, not a sensitizer. | Identical | |
| Irritation (ISO | |||
| 10993-10) | Under the conditions of the study, not an irritant. | ||
| Complies with ISO-10993-10. | Under the conditions of the study, not an irritant | Identical |
7
Discussion:
Note 1:
Although the materials used in the ear loops of the subject device and predicate masks are not the subject device confirms the same biocompatibility and performants as the predicate device. Therefore, this difference does not raise any new questions about safety and effectiveness.
Note 2
Although there is a slight difference in performance test results between the subject and predicate devices, they comply with the same performance standards ASTM F2100-19 Requirements for Level 2 face masks. The minor differences in the technological characteristics do not raise issues on the safety and effectiveness of the subject device.
8
VII. Performance Testing
Performance testing was provided to validate and verify that the Disposable Medical Mask, non-sterile, earloop met all requirements of related international standards, including biocompatibility and product specifications. These tests' results demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
Table of Conformity to Standards
| Standards | Scope |
|---|---|
| ASTM F2100-19 | |
| Standard Specification for Performance of Materials Used in | |
| Medical Face Masks | Performance |
| 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 | Performance: |
| Fluid Resistance Performance | |
| 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 | Performance: |
| Bacterial Filtration Efficiency | |
| (BFE) | |
| ASTM F2299-2003 | |
| Standard Test Method for Determining the Initial Efficiency of | |
| Materials Used in Medical Face Masks to Penetration by | |
| Particulates Using Latex Spheres | Performance: |
| Particulate Filtration Efficiency | |
| (PFE) | |
| ASTM F2100-19 | |
| EN14683: 2019 Annex C | |
| 16 CFR 1610 | Performance: |
| Differential Pressure (Delta P) | |
| Performance: | |
| Flammability | |
| ISO10993-1:2009 | |
| Biological evaluation of medical devices--Part 1: Evaluation and | |
| testing | Biocompatibility |
| ISO10993-5:2009 | |
| Biological Evaluation of Medical Devices - Part 5 Tests for In | |
| Vitro Cytotoxicity. | Biocompatibility |
| ISO10993-10:2002/Amd. 1:2006(E) | |
| Biological Evaluation of Medical Devices - Part 10: Tests for | |
| Irritation and Delayed-Type Hypersensitivity | Biocompatibility |
| FDA Guidance: Surgical Masks - Premarket Notification | |
| [510(k)] Submissions; Guidance for Industry and FDA | Guidance |
9
| Test | Standards | Acceptance Criteria
for Level 2 Mask | Result | Pass/Fail |
|--------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------|------------------------------|-----------|
| Bacterial Filtration Efficiency
(BFE, %) | ASTM F2101 | ≥ 98 | Average 99.79% | Pass |
| Particulate Filtration
Efficiency (PFE, at 0.1µm, %) | ASTM F2299 | ≥ 98 | Average 99.13% | Pass |
| Differential Pressure
(Delta P, mm H2O/cm2) | ASTM F2100-19
EN 14683:2019,
Annex C |