(88 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
Surgical masks are protective barriers intended to prevent the transfer of microorganisms and fluids, not to treat or cure a disease or condition.
No
Surgical masks are protective barriers designed to prevent the transfer of microorganisms and particulate material, not to diagnose medical conditions.
No
The device description clearly outlines a physical product (surgical masks) made of non-woven fabric and melt-blown polypropylene filter, with ear loops and a nose piece. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are worn to protect healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). This aligns with a physical barrier device, not a diagnostic assay or instrument.
- Performance Studies and Key Metrics: The performance studies focus on properties like fluid resistance, filtration efficiency (particulate and bacterial), breathability (differential pressure), flammability, and biocompatibility (irritation, sensitization, cytotoxicity). These are all characteristics relevant to a protective barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Disposable surgical masks are 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(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Disposable surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' 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 layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection);
- ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Face Masks by Particulates using Latex Sphere;
- 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;
- Determine breathing resistance or differential pressure as directed in EN 14683:2019, Annex C;
- ASTM F2100-2019 Standard Specification for Performance of Materials Used in Medical Face Masks;
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization.
Key Results:
- Fluid Resistance (ASTM F1862): 29 out of 32 pass at 120 mmHg (Pass)
- Particulate Filtration Efficiency (ASTM F2299): Lot1: 98.43%, Lot2: 98.18%, Lot3: 98.54% (≥ 98% criteria, Pass)
- Bacterial Filtration Efficiency (ASTM F2101): Lot1: 99.9%, Lot2: 99.9%, Lot3: 99.9% (≥ 98% criteria, Pass)
- Differential Pressure (MIL-M-36954C): Lot1: 3.5mmH2O/cm², Lot2: 3.1mmH2O/cm², Lot3: 3.3mmH2O/cm² (
§ 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, 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.
May 23, 2022
Xiamen Blue Star Enterprise Co., Ltd. % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co.,Ltd. 609 Room,No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China
Re: K220532
Trade/Device Name: Disposable surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 5, 2021 Received: February 24, 2022
Dear Sam Lin:
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,
for
Brent 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
2
Indications for Use
510(k) Number (if known) K220532
Device Name Disposable surgical mask
Indications for Use (Describe)
The Disposable surgical masks are 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(s), provided non-sterile.
Type of Use (Select one or both, as applicable)
| Research Use (21 CFR 201.26) | Sample Use (21 CFR 201.26) |
|---|---|
| ------------------------------------------------------- | ---------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Type of submission | Traditional |
|---|---|
| Date prepared | July 5, 2021 |
| Submission sponsor | |
| Manufacturer Name | Xiamen Blue Star Enterprise Co., Ltd. |
| Address | Room 201, South Building, No.506, Haiming Road, |
| Maxiang Town, Xiang'an District, Xiamen, China | |
| Tel | 86-13015920500 |
| 13015920500@163.com | |
| Contact Person | Jincong Zhang |
| Device identification | |
| Trade Name | Disposable surgical mask |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Name | Mask, Surgical |
| Device Classification | Class II |
| Product Code | FXX |
| Panel | General Hospital |
| Previous Submissions | None |
| Application correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New |
| District, Shanghai, China | |
| Tel | 86-18717927910 |
| sam@spicagloble.com | |
| Contact Person | Sam Lin |
Page 1 of 8 K220532
4
Predicate device information
| Sponsor | WUHAN DYMEX HEALTHCARE CO., LTD. |
|---|---|
| Trade/Device Name | SURGICAL FACE MASK |
| 510(K) number | K182515 |
| Regulation Number | 21 CFR 878.4040 |
Indications for use
The Disposable 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 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.
Device description
The Disposable surgical masks are single use, three-layer, flat - folded masks with ear loops and nose piece. The Disposable surgical masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric (polypropylene), and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' 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 layers of facemask is to allow the user to fit the facemask around their nose, which is made of spandex wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
5
510(K) Summar
echnological Characteristic Compariso
Provided below is a comparison of the subject device with the predicate device
able 6A: General Compariso
| Proposed Device | Predicate Device | Differences | |
|---|---|---|---|
| Discussion | |||
| Device name | Disposable surgical mask | SURGICAL FACE MASK | N/A |
| 510(k) number | K182515 | N/A | |
| Manufacturer | Xiamen Blue Star Enterprise Co., Ltd. | Wuhan Dymex Healthcare Co., Ltd | N/A |
| Product regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification name | Mask, Surgical | Mask, Surgical | Same |
| Regulation class | 2 | 2 | Same |
| Product code | FXX | FXX | Same |
| Indications for use | The Disposable 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 face masks | The 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 | Same | ||
| Rx or OTC | |||
| 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. | are intended for use in infection control practices 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. | Same | |
| OTC | OTC | Same | |
| Model | |||
| Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same | |
| Material | |||
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose clip | Polyethylene | Malleable polyethylene wire | Similar |
| Ear loops | Spandex | Spandex | Same |
| Color | Blue | Blue | Same |
| Dimension | 17cm X 9.5cm | 17.5cm X 9cm | Similar |
| Sterility | Non-Sterile | Non-Sterile | Same |
Page 3 of 8
K220532
6
510(K) Summary
Page 4 of 8
K220532
7
| Use | Single Use, Disposable | Single Use, Disposable | Same | ||
|---|---|---|---|---|---|
| Summary of Non-Clinical Testing | |||||
| Provided below is a summary of the performance testing of the subject devices to demonstrate that the device meets the specification or acceptance criteria of the standards and test methods shown below. | |||||
| Table 6B: Comparison of Non-clinical testing | |||||
| Item | Proposed device | Acceptance Criteria | Result | ||
| Fluid | |||||
| ASTM F1862 | Resistance | Performance 3 non-consecutive lots tested | 29 out of 32 pass at 120 mmHg | Pass | |
| Particulate | |||||
| ASTM F2299 | Filtration | Efficiency 3 non-consecutive lots tested | |||
| Lot1: 98.43% | |||||
| Lot2: 98.18% | |||||
| Lot3: 98.54% | ≥ 98% | Pass | |||
| Bacterial | |||||
| ASTM F2101 | Filtration | Efficiency 3 non-consecutive lots tested | |||
| Lot1: 99.9% | |||||
| Lot2: 99.9% | |||||
| Lot3: 99.9% | ≥ 98% | Pass | |||
| Differential | |||||
| MIL-M-36954C | Pressure (Delta P) | 3 non-consecutive lots tested | |||
| Lot1: 3.5mmH2O/cm² | |||||
| Lot2: 3.1mmH2O/cm² |