(43 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML technology.
No
The device is described as a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, primarily for infection control. It is not intended to treat or ameliorate a disease or condition, nor to restore, correct, or modify body functions, which are characteristics of a therapeutic device.
No
Explanation: The device, a surgical face mask, is described as protecting from transfer of microorganisms and body fluids. Its purpose is for infection control, not for diagnosing a medical condition.
No
The device description clearly outlines physical components (three-layer mask, nose piece, ear loops) and materials (polypropylene, iron core). It is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states the surgical face mask is intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Testing on Samples: The device description and performance studies do not mention any testing performed on samples taken from a patient. The tests described (filtration efficiency, pressure, blood penetration, flammability, biocompatibility) are all related to the physical properties and safety of the mask itself, not its ability to diagnose or provide information about a patient's health based on a sample.
Therefore, based on the provided information, the surgical face mask is a medical device, but it falls under a different category than In Vitro Diagnostics.
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. This face mask is 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Face Masks are blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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 or fiberglass.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Iron core coated with polypropylene resin.
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 as was same to the predicate device.
The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration: 3 lots tested with total 96 samples, 94/96 Passed at greater than or equal to 99% /Pass.
- EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019: 3 lots tested with total 96 samples, 92/96 Passed less than 4 mmH2O/cm squared / Pass.
- ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres according to ASTMF2100:2019: 3 lots tested with total 96 samples, 96/96 Passed at greater than or equal to 99% / Pass.
- ASTM 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) according to ASTMF2100:2019for pass result: 3 lots tested with total 96 samples, 95 of 96 test articles passed at 160mmHg / Pass.
- 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100:2019: 3 lots tested with total 96 samples, 96/96 Passed greater than or equal to 3 seconds burn Time- Class 1 / Pass.
Biocompatibility Testing: According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (less than or equal to 24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
- In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity.
- Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization.
- Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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August 3, 2021
Zhejiang Hongyu Medicali Commodity CO., LTD % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211897
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 21, 2021 Received: June 21, 2021
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.
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 and Part 809 ); medical device reporting (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 Clarence W. Murray III, Ph.D. 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) K211897
Device Name Surgical Face Mask
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. This face mask is 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.
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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510(K) Summary
K211897
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date prepared: August 3, 2021
A. Applicant Information:
ZHEJIANG HONGYU MEDICALI COMMODITY CO., LTD Address: No. 668 ChanHua Road, Fotang Town Industrial Functional Area, 322002, Yiwu City, Zhejiang Province, China Contact person: Sophie Title: Business Manager Tel: +86- 0579-85980762 Fax: +86- 0579-85070207 Email: 2853571191@qq.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. Subject Device Information:
Trade Name: Surgical Face Mask Common Name: SURGICAL MASK Model: Ear Loops
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
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C. Predicate device Information: K182515 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
D. Indications for use of the device:
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. This face mask is 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.
E. Device Description:
The Surgical Face Masks are blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond 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 or fiberglass.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Iron core coated with polypropylene resin.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
F. Comparison with predicate device
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| 510K # | K211897 | K182515 | - | |
| Manufacturer | ZHEJIANG HONGYU MEDICALI | |||
| COMMODITY CO., LTD | Wuhan Dymex Healthcare Co., Ltd. | - | ||
| Model Name | SURGICAL FACE MASK | |||
| Ear loops | SURGICAL FACE MASK | |||
| Ear loops | Same | |||
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | ||
| Indication for use | The Surgical Face Mask is | |||
| intended to be worn to protect | ||||
| both the patient and | ||||
| healthcare personnel from | The Surgical Face Masks are | |||
| intended to be worn to protect both | ||||
| the patient and healthcare | ||||
| personnel from transfer of | Same | |||
| transfer of microorganisms, body fluids and particulate material. This face mask is 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. | 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. | |||
| Design Features | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same | |
| Materials | Outer layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Inner layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | |
| Filter layer | Melt-blown Polypropylene | Melt-blown Polypropylene | Same | |
| Nose wire | Iron core coated with polypropylene resin | Malleable polyethylene wire | Different | |
| Ear loops | Polyester + spandex | Spandex | Different | |
| Color | Blue | Yellow | Different | |
| Dimension (Length) | 17.5cm±0.2cm | 17.5cm±0.2cm | Same | |
| Dimension (Width) | 9.5cm±0.2cm | 9.5cm±0.2cm | Same | |
| Dimension (Ear Loops) | 17cm±0.2cm | 16.5cm±0.5cm | Similar | |
| 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 2 | Different | |
| Biocompatibility | Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic | Same |
| Irritation | Under the conditions of the study, the subject device extract was determined to be non-irritant | Under the conditions of the study, the subject device extract was determined to be non-irritant | Same | |
| Sensitization | Under the conditions of the study, the subject device extract was determined to be non-sensitizer | Under the conditions of the study, the subject device extract was determined to be non-sensitizer | Same |
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The proposed device has different material of nose piece, ear loops and different color to the predicate device, while the proposed device has been tested and the test results shown that the material and color differences do not affect the safety of the proposed device.
The proposed device is similar in design, intended use, technological characteristics, and is composed of the same or similar components as the predicate device. The product proposed under this premarket notification
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submission has the same or similar performance characteristics and conform to the same or similar standards. Differences of the penetration level between the Surgical Face Masks and predicate devices did not raise any new concerns regarding safety and effectiveness.
G. Summary of Non-Clinical Test
A
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:
| Test Method | Purpose | Pass Criteria | Results |
|---|---|---|---|
| ASTM F2101-19 Standard | |||
| TestMethod for Evaluating | |||
| the Bacterial Filtration | The purpose of the test is to | ||
| evaluate the Bacterial filtration | |||
| efficiency (BFE) (%) | ≥98% | 3 lots tested with total | |
| 96 samples, | |||
| 94/96 Passed at | |||
| ≥99% /Pass | |||
| EN 14683: 2019, Annex C | |||
| Medical face masks - | |||
| Requirements and | |||
| test methods according to | |||
| ASTM F2100:2019 | The purpose of the test is to | ||
| evaluate the Different pressure | |||
| (Delta-P) |