(40 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a standard surgical face mask. There is no mention of any computational or analytical functions that would involve AI or ML.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is intended for protection from transfer of microorganisms and particulate material, not for treatment.
No
A diagnostic device is used to identify a disease, condition, or injury. This surgical face mask is intended to protect against the transfer of microorganisms and particulate material, not to diagnose any condition.
No
The device description clearly outlines the physical components and materials of a surgical face mask, which is a hardware device. There is no mention of software as part of the device itself.
No, 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. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, resistance to penetration, flammability, biocompatibility). These are not studies related to the accuracy or performance of a diagnostic test.
- Key Metrics: The key metrics are related to the mask's ability to filter and resist penetration, not diagnostic values like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This surgical face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Surgical 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 Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Face Masks are blue color, four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer, second facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.
The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the second facing layer is made of nylon single way filting net, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.
The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.
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 specification.
Study Type: Performance Testing (Bacterial Filtration Efficiency, Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, Flammability) and Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation).
Key Results:
- Bacterial Filtration Efficiency: Passed (≥98%)
- Differential Pressure: Passed (
§ 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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June 6, 2022
Shanghai Hua En Industrial CO LTD % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K221222
Trade/Device Name: Surgical Face Mask (HNFM0304) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 27, 2022 Received: April 27, 2022
Dear Ivy Wang:
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.
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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.
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
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Indications for Use
510(k) Number (if known) K221222
Device Name Surgical Face Mask (HNFM0304)
Indications for Use (Describe)
The Surgical 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 Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided nonsterile.
| Type of Use (Select one or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
(As requirement by 21 CFR 807.92)
Date prepared: 1st, June, 2022
A. Applicant:
Name: SHANGHAI HUA EN INDUSTRIAL CO LTD Address: #30, NO988 HUI JI ROAD, XUANQIAO TOWN, PUDONG,SHANGHAI CHINA 201314 Contact: Lisa Zhao Title: General Manager Tel: +86- 15618875177 Email: lisa.zhao@hnind.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device: Trade Name: Surgical Face Mask Model: HNFM0304
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device: K212097 Disposable medical surgical mask Hebei Titans Hongsen Medical Technology Co., Ltd
D. Indications for use of the device:
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The Surgical 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 Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Surgical Face Masks are blue color, four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer, second facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.
The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the second facing layer is made of nylon single way filting net, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.
The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.
F. Non-clinical Test Conclusion
The Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.
| Test Methodology | Purpose | Acceptance Criteria for Level
3 Barrier | Result |
|---------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------|--------|
| Bacterial Filtration
Efficiency
ASTM F2101 | Measure bacterial filtration
efficiency | ≥98% | Passed |
| Differential Pressure
(mmH2O/cm²)
EN 14683:2019
Annex C | Determine breathability of
the mask | ISO 10993-05:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
-
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- A EN 14683, Medical Face Masks - Requirements and Test Methods
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
-
ASTM F2299. Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles
Clinical Test Conclusion I.
No clinical study is included in this submission.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K212097.