(108 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of surgical masks, with no mention of AI or ML technology.
No
The device is a surgical mask intended to protect against exposure to microorganisms and body fluids, not to treat or diagnose a disease or condition.
No
The Medical Surgical Mask is intended to protect from transfer of microorganisms and body fluids, not to diagnose a condition.
No
The device description clearly outlines physical components (spunbond polypropylene, meltblown polypropylene, polyethylene, iron, spandex) and manufacturing processes (welding), 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 masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of components designed to analyze samples or provide diagnostic information.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This mask does not perform any such analysis.
- Performance Studies: The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are relevant to a barrier device, not a diagnostic one.
Therefore, the Medical Surgical Masks described are considered medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications 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 to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.
Product codes
FXX
Device Description
The Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. 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 Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.
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:
- 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 of Fixed Volume at a Known Velocity)
- 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
- 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 10993-5:2009 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 irritaion and skin sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Particulate filtration efficiency: Level 2 mask: average 99.71%, Level 3 mask: average 99.93%
- Bacterial filtration efficiency: Level 2 mask: average 99.7%, Level 3 mask: average 99.9%
- Differential pressure: Level 2 mask: average 2.8mmH2O/cm2, Level 3 mask: average 4.0 mmH2O/cm2
- Flammability: Class 1
- Fluid resistance: Level 2: Pass at 120mmHg, Level 3: Pass at 160mmHg
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). 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2021
Tianjin Aoshang Outdoor Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 China
Re: K210030
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 4, 2021 Received: January 5, 2021
Dear Diana Hong:
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.
Ryan Ortega, PhD Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Medical surgical mask
Indications for Use (Describe)
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 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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Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K210030
- Date of Preparation: 03/09/2021 1.
-
- Sponsor Identification
Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District, Tianjin
Establishment Registration Number: 3016716690.
Contact Person: Xiaoning Zhang Position: QS Engineer Tel: +86-22-87702678 Fax: +86-22-87702677 Email: zhangning860222@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Medical surgical mask Common Name: Surgical mask
Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
Indication 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 to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Device Description:
The Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. 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 Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.
5. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K201479 Product Name: DemeMASK Surgical Mask
Predicate Device 2 510(k) Number: K153496
5
Product Name: Disposable Surgical Face Mask
-
- 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:
- Non-Clinical Test Conclusion
-
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 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
-
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
-
ハ EN 14683: 2019, Annex C, Medical face masks- Requirements and test methods
-
ハ ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
A ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
-
Clinical Test Conclusion 7.
No clinical study is included in this submission.
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8. Summary of Technological characteristics
| ITEM | Proposed Device K210030 | Predicate Device 1 K201479 | Predicate Device 2 K153496 | Remark |
|---|---|---|---|---|
| Product Code | FXX | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | II | Same |
| Indication 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 to reduce the potential exposure to blood and body fluids. This 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 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. | Same |
| Mask style | Flat-pleated | Flat-pleated | Flat-pleated | Same |
| ASTM F2100 Level | Level 2 and Level 3 | Level 3 | Level 2 | Similar |
| Design feature | Level 2: Ear loop | |||
| Level 3: Ear loop and Tie-on | Ear loop and Tie-on | Ear loop and Tie-on | Similar | |
| Color | Blue | Blue | Blue | Same |
| Dimension | 17.5cm×9.5cm | 17.5cm×9.5cm | 17.5cm×9.5cm | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Single Use, Disposable | Same |
| Particulate filtration efficiency | Level 2 mask: average 99.71% | |||
| Level 3 mask: average 99.93% | ≥99% | 98.46% | Different | |
| Bacterial filtration efficiency | Level 2 mask: average 99.7% | |||
| Level 3 mask: average 99.9% | ≥99% | 98.7% | Different | |
| Differential | Level 2 mask: average | $3.6mmH_2O/cm^2$ | $4.2mmH_2O/cm^2$ | Different |
| pressure | 2.8mmH2O/cm2 | |||
| Level 3 mask: average 4.0 mmH2O/cm2 | ||||
| EN 14683 | MIL-M-36954C | MIL-M-36954C | ||
| Flammability | Class 1 | Class 1 | Class 1 | Same |
| Fluid resistance | Level 2: Pass at 120mmHg | |||
| Level 3: Pass at 160mmHg | Pass at 160mmHg | Pass at 120mmHg | Similar | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Patient Contacting Material | ||||
| Outer facing layer | Spunbond Polypropylene | Spunbond Polypropylene | Spunbond Polypropylene | |
| Middle layer | Meltblown Polypropylene Filter | Meltblown Polypropylene Filter | Meltblown Polypropylene Filter | |
| Inner facing layer | Spunbond Polypropylene | Spunbond Polypropylene | Spunbond Polypropylene | |
| Nose clip | PE and Iron | Galvanized wire coated with polyethylene | Malleable aluminum wire | Different |
| Ear loop | Spandex | Spandex and Nylon - Not made from natural rubber latex | Polyester | |
| Ties | Spunbond Polypropylene | Spandex and Nylon - Not made from natural rubber latex | Spun-bond polypropylene | |
| 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. | 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. | Same |
Table 1 Comparison of Medical Surgical Masks
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Similar - ASTM F2100 Level
The proposed devices are available in two types, which are Level 2 and Level 3 based on ASTM F2100-19. The proposed Level 2 mask can be covered by the predicate device K201479 and proposed Level 3 mask can be covered by the predicate device K153496. This difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
8
Similar - Design feature
The proposed Level 2 masks are ear-loop masks. The proposed 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 two predicate devices. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
Different - Particulate filtration efficiency
The test result for particulate filtration efficiency for the proposed device is different from the two predicate devices. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the proposed device is different from the two predicate devices. However, the test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
Different - Differential pressure
The test result for differential pressure for the proposed device is different from the two predicate devices. 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 two predicate devices.
Similar - Fluid resistance
The proposed devices are available in two types, which are Level 3 based on ASTM F2100-19. The test result for the proposed device can meet the requirements of level 2 mask and Level 3 mask. Thus, this difference will not affect the safety and effectiveness between the proposed device and the two predicate devices.
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from the two predicate devices. 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
9
proposed device and the two predicate devices.
9. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(K) submission K210030, the Medical surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate devices cleared under K201479 and K153496.