(280 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a surgical mask intended to protect against microorganisms and body fluids, not to treat or cure a disease or condition.
No
The document describes a Medical Surgical Mask intended for protection from transfer of microorganisms, body fluids, and particulate material. Its function is barrier protection, not diagnosis of a disease or medical condition.
No
The device description clearly outlines physical components like polypropylene fabric, iron wire, and spandex, 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 is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical components and materials of a surgical mask. There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (PFE, BFE, differential pressure, flammability, fluid resistance) and biocompatibility. These are relevant to a barrier device, not a diagnostic test.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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 Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 2 and Level 3 based on ASTM F2100-19.
The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask.
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
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device.
Performance testing:
- Test Item: Particulate Filtration Efficiency (PFE)
Reference Standard: ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres.
Acceptance criteria: >= 98%
Test results: Pass - Test Item: Differential Pressure
Reference Standard: ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks.
Acceptance criteria: = 98%
Test results: Pass - Test Item: Flammability of Clothing Textiles
Reference Standard: 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
Acceptance criteria: Class I
Test results: Pass - Test Item: Synthetic Blood Penetration Resistance
Reference Standard: 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);
Acceptance criteria: Level 2: Pass at 120mmHg, Level 3: Pass at 160mmHg
Test results: Pass
Biocompatibility testing:
Biocompatibility of the Medical Surgical Mask was evaluated in accordance with ISO 10993-1:2018.
- Test Item: In Vitro Cytotoxicity
Reference Standard: ISO10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Acceptance criteria: Under the conditions of the study, the proposed device extract is determined to be non-cytotoxic
Test results: Pass - Test Item: Skin Irritation
Reference Standard: ISO10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
Acceptance criteria: Under the conditions of the study, the proposed device extract is determined to be non-irritating
Test results: Pass - Test Item: Skin Sensitization
Reference Standard: ISO10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Acceptance criteria: Under the conditions of the study, the proposed device extract is determined to be non-sensitizing
Test results: Pass
No clinical tests were performed.
Key Metrics
Not Found
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 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 19, 2024
Azur Medical Company Inc. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
Re: K231719
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 8, 2024 Received: March 8, 2024
Dear Esther Zhang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231719
Device Name Medical Surgical Mask
Indications for Use (Describe)
The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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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4
510(k) summary K231719
l Submitter
Device submitter: Azur Medical Company Inc. 6710 Everglades Dr., Richmond, Virginia, VA 23225, USA
Contract manufacturer: Wepon Medical Technology CO., LTD. Floor 4, Building A, No. 58, Jinhu Road, Chengdong Street, Wenling Zhejiang, CN 317500
Contact person: Di Zhao General Manager Phone: 928-5922380 Email: dzhao@azur-ppe.com Date: March 14, 2024
II Device
Trade Name of Device: Medical Surqical Mask Common name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation name: Mask, Surgical Regulatory Class: II Product code: FXX Review Panel: General Hospital
III Correspondent
Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: Esther.zhang@llins-tech.com
IV Predicate Device
| 510(k) Number: | K210030 |
|---|---|
| Trade/Device Name: | Medical Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FXX |
5
V Device description
The Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 2 and Level 3 based on ASTM F2100-19.
The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask.
This is a single use, disposable device(s), provided non-sterile.
VI Indications for use
The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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.
VII Comparison of technological characteristics with the predicate device
The Medical Surgical Mask has similar intended use, technology, design and performance specifications to the proposed legally marketed predicate device.
| Item | Subject device
(K231719) | Predicate device
(K210030) | Discussion |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Medical Surgical Mask | Disposable Surgical Face
Mask | NA |
| Product Code | FXX | FXX | identical |
| Intended use | The Medical Surgical Mask
is intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. These surgical
masks are intended for use | The Medical Surgical Masks
are intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material.
These surgical
masks are intended for use
in infection control practices | identical |
| | 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. | to reduce the potential
exposure to blood and body
fluids. This is a single use,
disposable device(s),
provided non-sterile. | identical |
| Mask style | Flat-pleated | Flat-pleated | identical |
| ASTM F2100 Level | Level 2 and Level 3 | Level 2 and Level 3 | identical |
| Design feature | Level 2: Ear loop
Level 3: Ear loop | Level 2: Ear loop
Level 3: Ear loop and Tie-on | Different, see
explanation
below |
| Color | Blue | Blue | identical |
| Dimension | 17.5cmx9.5cm | 17.5cmx9.5cm | identical |
| Sterility | Non-Sterile | Non-Sterile | identical |
| Shelf life | 2 years | Unknown | Different, see
explanation
below |
| Use | Single Use, Disposable | Single Use, Disposable | identical |
| Particulate
filtration
efficiency | Level 2 and Level 3:
average 99.96% | Level 2 mask: average
99.71%
Level 3 mask: average
99.93% | Different, see
explanation
below |
| Bacterial filtration
efficiency | Level 2 and Level 3:
average 99.9% | Level 2 mask: average
99.7%
Level 3 mask: average
99.9% | Different, see
explanation
below |
| Differential pressure | Level 2 and Level 3:
average 2.8 mmH2O/cm 2 | Level 2 mask: average
2.8mmH2O/cm 2
Level 3 mask: average 4.0
mmH2O/cm 2
EN 14683 | Different, see
explanation
below |
| Flammability | Class 1 | Class 1 | identical |
| Fluid resistance | Level 2: Pass at 120mmHg
Level 3: Pass at 160mmHg | Level 2: Pass at 120mmHg
Level 3: Pass at 160mmHg | identical |
| Label/Labeling | Complied with 21 CFR part
801 | Complied with 21 CFR part
801 | identical |
| Patient
Contacting | Outer
facing
layer
polypropylene non-woven
fabric | Spunbond Polypropylene | Different, see
explanation
below |
| | Middle layer | polypropylene meltblown fabric | Meltblown Polypropylene Filter |
| | Inner facing layer | polypropylene non-woven fabric | Spunbond Polypropylene |
| | Nose clip | polypropylene and iron wire | PE and Iron |
| | Ear loops | spandex | Spandex |
| Biocompatibility | | ISO 10993-5 and ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to
be non-cytotoxic, non-
sensitizing, and non-
irritating. | ISO 10993-5 and ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to
be non-cytotoxic, non-
sensitizing, and non-
irritating. |
| | | identical | |
Table 5-1 Substantial equivalence discussion - Medical Surgical Mask
6
7
Different- Design feature
The proposed masks are ear-loop masks. The predicate Level 3 masks are available in two types, ear-loop and Tie-on. The design features of the two levels of masks for the proposed device can be covered by the design features of the predicate device. Thus, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
Different-Shelf life
The shelf life of the predicate device is unknown and the proposed mask is 2 years. Shelf life testing has been conducted for the proposed device based on accelerated aging. A real-time aging study is underway. Therefore, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
Different - Particulate filtration efficiency
The test result for particulate filtration efficiency for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask based on ASTM F2100-19. Thus, this
8
difference will not affect the safety and effectiveness between the proposed device and the predicate device.
Different - Differential pressure
The test result for differential pressure for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from the predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
VIII Summary of Non-Clinical Tests
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device.
| No. | Test Item | Reference Standard | Acceptance criteria | Test results |
|---|---|---|---|---|
| 1. | Particulate | |||
| Filtration | ||||
| Efficiency | ||||
| (PFE) | ASTM F2299/F2299M-03 (2017) | |||
| Standard Test Method for | ||||
| Determining the Initial Efficiency of | ||||
| Material Used in medical Face | ||||
| Masks to Penetration by | ||||
| Particulates using Latex Spheres. | $\ge$ 98% | Pass | ||
| 2. | Differential | |||
| Pressure | ASTM F2100: 2019 Standard | |||
| Specification for Performance of | ||||
| Materials Used in Medical Face | ||||
| Masks. | $ |