(63 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a disposable face mask, with no mention of AI or ML.
No
The device is a medical face mask, intended to prevent the transfer of microorganisms, body fluids, and particulate material, and to reduce exposure to blood and body fluids. It is a barrier and not used for treatment or therapy.
No
The device is a medical face mask intended to protect against the transfer of microorganisms and body fluids. Its purpose is protective, not diagnostic.
No
The device description clearly outlines physical components (Spunbond polypropylene, Meltblown polypropylene, ear loops, nose clip) and performance studies focus on material properties and physical resistance, indicating it is a physical medical device, not software-only.
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 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.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility), which are relevant to its function as a barrier, not as a diagnostic tool.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This face mask does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Medical 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.
Product codes
FXX
Device Description
The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear.
The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering.
This is a single use, disposable device(s), provided non-sterile.
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 conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
- 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: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- EN 14683: 2019. Annex C. Medical face masks- Requirements and test methods
- ISO 10993-5:2012 Biological evaluation of medical device- Part 12: Sample preparation and reference materials
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
The patient contacting material biocompatibility test results do not show any adverse effect.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include:
- Particulate filtration efficiency:
- Lot 1: 99.926%
- Lot 2: 99.93%
- Lot 3: 99.936%
- Bacterial filtration efficiency:
- Lot 1: ≥99%
- Lot 2: ≥99%
- Lot 3: ≥99%
- Differential pressure: Tested across 3 non-consecutive lots, using a sample size of 32/lot. No specific numerical results provided for subject device, but predicate device results are 3.6 mm H2O/cm^2 and 3.7 mm H2O/cm^2.
- Flammability: Class1
- Fluid resistance: Pass at 120 mmHg (32 out of 32 per lot pass at 120 mmHg, 3 non-consecutive lots tested)
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 26, 2022
Hubei Mediunion Medical Products Co., Ltd. Jason Sheen Vice President No.1 ChuangYe Road, Zhongling Industrial Zone, Pengchang Town Xiantao. Hubei 433000 China
Re: K220487
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 9, 2022 Received: February 22, 2022
Dear Jason Sheen:
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 L. 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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Indications for Use
510(k) Number (if known) K220487
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The Disposable Medical 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.
| 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
Section 3-510(k) summary
I Submitter
| Device submitter: Hubei Mediunion Medical Products Co., Ltd. |
|---|
| No.1 Chuang Ye Road, Zhongling Industrial Zone, Pengchang Town |
| Xiantao city, Hubei province, China |
- Contact person: Jason Sheen Vice President Phone: 0086-574-27882323 E-mail: jason@cehcare.com Date Prepared: April 25, 2022
II Proposed Device
| Trade/Device Name: | Disposable medical face mask |
|---|---|
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Regulatory Class: | Class II |
| Product code: | FXX |
III Predicate Devices
| 510(k) Number: | K202211 |
|---|---|
| Trade/Device Name: | Disposable Medical Surgical Face Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | Guangdong Kaidi Garments Co.,Ltd |
IV Device description
The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear.
The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering.
4
This is a single use, disposable device(s), provided non-sterile.
V Indication for use
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable medical face mask is 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.
VI Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
- A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- A 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)
- A ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- A ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
- EN 14683: 2019. Annex C. Medical face masks- Requirements and test methods >
- A ISO 10993-5:2012 Biological evaluation of medical device- Part 12: Sample preparation and reference materials
- A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
VII Clinical Test Conclusion
No clinical study is included in this submission.
VIII Summary of Technological characteristics
Table 1 Comparison of Disposable Medical face Mask
| Item | Subject device | Predicate device | Discussion | |
|---|---|---|---|---|
| Product name | Disposable medical face | |||
| mask | Disposable Medical | |||
| Surgical Face Masks | NA | |||
| 510K number | K202211 | NA | ||
| Product Code | FXX | FXX | identical | |
| Intended use | The Disposable Medical | |||
| Face Mask is intended to | ||||
| be worn to protect both the | The disposable medical | |||
| surgical face masks are | identical | |||
| patient and healthcare | ||||
| personnel from transfer of | ||||
| microorganisms, body | ||||
| fluids and particulate | ||||
| material. The Disposable | ||||
| Medical Face Mask is | ||||
| 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. | 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),provide | ||||
| non-sterile. | ||||
| ASTM F2100Level | Level 2 | Level 2 | identical | |
| Design feature | ear loop or tie-on | ear loop | Similar | |
| Color | Blue | Blue | identical | |
| Dimension | 175mmx95mm | 175mmx95mm | identical | |
| Sterility | Non-Sterile | Non-Sterile | identical | |
| Use | Single Use, Disposable | Single Use, Disposable | identical | |
| Particulate | ||||
| filtration | ||||
| efficiency | 3 non-consecutive lots | |||
| tested, using a sample size | ||||
| of 32/lot. | ||||
| Lot 1: 99.926% | ||||
| Lot 2: 99.93% | ||||
| Lot 3: 99.936% | 3 non-consecutive lots | |||
| tested, using a sample size | ||||
| of 32/lot. | ||||
| Lot 1: 99.68% | ||||
| Lot 2: 99.56% | ||||
| Lot 3: 99.81% | Similar | |||
| Bacterial filtration | ||||
| efficiency | 3 non-consecutive lots | |||
| tested, using a sample size | ||||
| of 32/lot. | ||||
| Lot 1: ≥99% | ||||
| Lot 2: ≥99% | ||||
| Lot 3: ≥99% | 3 non-consecutive lots | |||
| tested, using a sample size | ||||
| of 32/lot. | ||||
| Lot 1: 99.9% | ||||
| Lot 2: 99.9% | ||||
| Lot 3: 99.9% | Similar | |||
| Differential pressure | 3 non-consecutive lots | |||
| tested, using a sample size | ||||
| of 32/lot. | 3 non-consecutive lots | |||
| tested, using a sample size | ||||
| of 32/lot. | Similar | |||
| Lot 2: |