(162 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a standard medical face mask, with no mention of AI or ML technologies.
No
The mask is designed to protect from the transfer of microorganisms and body fluids, not to treat a disease or condition.
No
The device is a medical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its function is protective, not diagnostic.
No
The device description clearly outlines a physical, multi-layered face mask made of non-woven materials with ear loops and a nose clip. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware devices. There is no mention of software components or functions.
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 healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It's a physical barrier device.
- Device Description: The description details the physical construction and materials of the mask.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are not tests related to analyzing samples from the human body.
- 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 treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic or other health-related information. This medical face mask does not fit that description.
N/A
Intended Use / Indications for Use
The Single-use medical face mask is intended to be worn to protect 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, provided nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire.
The proposed device(s) are sold non-sterile and are intended to be 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
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 Performance Testing:
- Test Methodology: Fluid Resistance Performance (mmHg) ASTM F1862
Purpose: In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3.
Acceptance Criteria for Level 3: Pass at 160mmHg
Test Results: PASS Average of 3 batch numbers: 160mmHg - Test Methodology: Particulate Filtration Efficiency Performance (%) ASTM F2299
Purpose: In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3.
Acceptance Criteria for Level 3: ≥ 98%
Test Results: PASS Average of 3 batch numbers: 98.79% - Test Methodology: Bacterial Filtration Efficiency Performance (%) ASTM F2101
Purpose: In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3.
Acceptance Criteria for Level 3: ≥ 98%
Test Results: PASS Average of 3 batch numbers: 99.87% - Test Methodology: Differential Pressure (Delta-P) (mmH2O/cm²) MIL-M-36954C
Purpose: In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3.
Acceptance Criteria for Level 3:
§ 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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July 22, 2021
Zhuhai Herald Datanetics Limited. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China
Re: K210391
Trade/Device Name: Single-use medical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 11, 2021 Received: June 17, 2021
Dear Cassie Lee:
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.
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
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Indications for Use
510(k) Number (if known) K210391
Device Name
Single-use medical face mask (Model: HD0969)
Indications for Use (Describe)
The Single-use medical face mask is intended to be worn to protect 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, provided nonsterile.
| 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
510(k) Summary
This summary of 510(K)is being submitted in accordance with the requirement of 21 CFR 807.92.
Subject Device: Single-use medical face mask (Model: HD0969) 510(k) Number: K210391
1. Date of the summary prepared: July 22, 2021
2. Submitter's Information
510(k) Owner's Name: Zhuhai Herald Datanetics Limited. Establishment Registration Number: Applying Address: Building#2, No.1 Pingxi Road 6, Nanping Science and Technology Industrial Park, Zhuhai, Guangdong, China Contact Person: Jackson Leung Email: jacksonleung@heraldata.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: requlatory@share-info.com
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Surgical Face Mask Trade Name: Single-use medical face mask Model Name: HD0969 Review Panel: Surqical Apparel Product Code: FXX Requlation Number: 878.4040 Requlatory Class: 2
4. Predicate Device Information
Sponsor: DemeTECH Corporation Trade Name: DemeMASK Surgical Mask Classification Name: Surgical Face Mask 510(K) Number: K201479 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulation Class: 2
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5. Indications for Use
The Single-use 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, provided non-sterile,
6. Device Description
The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
| Elements of
| Comparison | Subject Device | Predicate Device | Result | |
|---|---|---|---|---|
| Company | Zhuhai Herald Datanetics Limited. | DemeTECH Corporation | -- | |
| 510 (k) Number | K210391 | K201479 | -- | |
| Trade Name | Single-use medical face mask | DemeMASK Surgical Mask | -- | |
| Classification | ||||
| Name | Surgical Face Mask | Surgical Face Mask | Same | |
| Classification | Class II Device, FXX (21 | |||
| CFR 878.4040) | Class II Device, FXX (21 | |||
| CFR 878.4040) | Same | |||
| Indication for | ||||
| use | The Single-use 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, | ||||
| 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 provided | ||||
| nonsterile. | Same | |||
| Material | Outer | |||
| facing | ||||
| layer | Spun-bonded non-woven | Spun-bond polypropylene | Similar | |
| Note 1 | ||||
| Middle | ||||
| layer | Melt-Blown non-woven | Melt blown polypropylene filter | Similar | |
| Note 1 | ||||
| Inner | ||||
| facing | Spun-bonded non-woven | Spun-bond polypropylene | Similar | |
| Note 1 |
7. Summary of Technological Characteristics
Provided below is a comparison of the subject device and predicate device
5
| Elements of
| Comparison | Subject Device | Predicate Device | Result | |
|---|---|---|---|---|
| layer | ||||
| Nose | ||||
| clip | PE coated Tin-plate wire | Galvanized wire coated with | ||
| polyethylene | Similar | |||
| Note 1 | ||||
| Ear | ||||
| loops | Spandex | Spandex and Nylon - Not | ||
| made from natural rubber | ||||
| latex | Similar | |||
| Note 1 | ||||
| Color | white + blue | Not Applicable | Similar | |
| Note 1 | ||||
| Dimensions | 175mm×95mm | Length: 17.5 cm±1 cm | ||
| Width: 9.5 cm±1 cm | Similar | |||
| Note 1 | ||||
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 | ||||
| Level | Level 3 | Level 3 | Same | |
| Fluid Resistance | ||||
| Performance | Pass at 160 mmHg | Pass at 160 mmHg | Same | |
| Particulate | ||||
| Filtration | ||||
| Efficiency | ≥ 98% | Pass at ≥99% | Similar | |
| Note 2 | ||||
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ≥ 98% | Pass at ≥99% | Similar | |
| Note 2 | ||||
| Differential | ||||
| Pressure | On average of 4.7 mmH2O/cm2 | Average 3.6 mmH2O/cm2 | Similar | |
| Note 2 | ||||
| Flammability | Class 1 | Class 1 | Same |
Comparison in Detail(s): Note 1:
Although the "Material" "Color" and "Dimensions" of subject device are slightly difference with predicate device, it meets the requirement standard ASTM F2100, ASTM F2101, and ISO 10993. Note 2:
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is a little different from the predicate device, and they all meet the requirements of essential performance standard ASTM F2100.
Summary of Non-Clinical Performance Testing Performance Testing summary
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| Test Methodology | Purpose | Acceptance Criteria
for Level 3 | Test Results |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------|---------------------------------------------------------|
| Fluid Resistance Performance
(mmHg)
ASTM F1862 | In order to verify whether the subject
equipment meets the performance
requirements of ASTM F2100 level 3. | Pass at 160mmHg | PASS
Average of 3
batch numbers:
160mmHg |
| Particulate Filtration Efficiency
Performance (%)
ASTM F2299 | In order to verify whether the subject
equipment meets the performance
requirements of ASTM F2100 level 3. | ≥ 98% | PASS
Average of 3
batch numbers:
98.79% |
| Bacterial Filtration Efficiency
Performance (%)
ASTM F2101 | In order to verify whether the subject
equipment meets the performance
requirements of ASTM F2100 level 3. | ≥ 98% | PASS
Average of 3
batch numbers:
99.87% |
| Differential Pressure (Delta-P)
(mmH2O/cm²)
MIL-M-36954C | In order to verify whether the subject
equipment meets the performance
requirements of ASTM F2100 level 3. |