(140 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 suggest the use of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device's intended use is to protect from the transfer of microorganisms, body fluids, and particulate matter, for infection control practices, which is preventive in nature rather than therapeutic.
No
The text explicitly states that 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." This function is protective, not diagnostic.
No
The device description clearly outlines a physical product made of materials like polypropylene, 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical face 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 or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, fluid resistance, and flammability. These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
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. Surgical Face Masks are single use, disposable devices, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
Surgical Face Mask contains one model called YOD2001. YOD2001 Surgical Face Mask is in white, barrier level 2, size 173mm*97mm, flat pleated and ear loop type. YQD2001 Surgical Face Mask is a flat pleated type mask composed of three layers. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of polypropylene to provide a firm fit over the nose.
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 Performance Tests:
- Bacterial Filtration Efficiency: ASTM F2101 Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus. Pass Criteria: >=98%. Test Results: Pass.
- Differential Pressure (Delta-P): EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019. Pass Criteria: =98%. Test Results: Pass.
- Resistance to Penetration by Synthetic Blood: 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). Pass Criteria: Fluid resistant claimed at 120 mm Hg. Test Results: Pass.
- Flammability: 16 CFR Part 1610 Standard for the Flammability of Clothing. Pass Criteria: Class 1. Test Results: Pass.
Biocompatibility Testing (Based on ISO 10993-1:2018):
- In Vitro Cytotoxicity Test per ISO 10993-5: 2009. Result: non-cytotoxic.
- Skin Sensitization Tests per ISO 10993-10: 2010. Result: non-sensitizing.
- Skin Irritation Tests per ISO 10993-10: 2010. Result: non-irritating.
No clinical study is included in this submission.
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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December 6, 2021
Shanghai Yunqing Industrial Co., Ltd. Ryan Li RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, 200040 China
Re: K212235
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 28, 2021 Received: November 8, 2021
Dear Ryan Li:
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 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.
For Clarence W. Murray III, PhD 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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Indications for Use
510(k) Number K212235
Device Name Surgical Face Mask
Indications for Use (Describe)
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. Surgical Face Masks are single use, disposable devices, 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-K212235
I. SUBMITTER:
Shanghai Yunqing Industrial Co., Ltd. 2nd buliding1818, shangsu road,fengxian district, Shanghai, China Contact Person: Hulin Title: QA Manager Tel: +86 15921265138 Email: HL@yqgroup.vip
Submission Correspondent: Ryan Li Email: ryan.li(@mind-link.net Tel:+86 13701581791
Summary prepared: October 26, 2021
II. DEVICE
Name of Device: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX
III. PREDICATE DEVICE
Primary predicate device:
Predicate: K182514 Trade/Device Name: Surgical Face Mask Manufacturer: Xiantao Zhibo Non-Woven Products Co., Ltd Product Code: FXX Classification Name: Mask, surgical Regulation Number: 21 CFR 878.4040
IV. DEVICE DESCRIPTION
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Surgical Face Mask contains one model called YOD2001.
YOD2001 Surgical Face Mask is in white, barrier level 2, size 173mm*97mm, flat pleated and ear loop type.
YQD2001 Surgical Face Mask is a flat pleated type mask composed of three layers. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of polypropylene to provide a firm fit over the nose.
V. INDICATIONS FOR USE
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. Surgical Face Masks are single use, disposable devices, provided non-sterile.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Surgical Face Masks are compared with the predicate device Surgical Face Mask (K182514). The results are shown below in the Technological Characteristics Comparison Table:
| DEVICE | Subject Device | Primary Predicate Device | Remark |
|---|---|---|---|
| Surgical Face Mask | Surgical Face Mask (K182514) | ||
| Intended Use | 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 for use in infection control practices to reduce the potential exposure to blood and body fluids. Surgical Face Masks are single | 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 for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided | Same |
| use, disposable devices, providednon-sterile. | |||
| non-sterile. | |||
| Classification | FXX | FXX | Same |
| Product Code | |||
| Model | Ear Loop | Ear loop | Same |
| Materials | |||
| Outer Facing Layer | Spun-bond | ||
| non-woven fabric | polypropylene Spun-bond polypropylene | Similar | |
| Note 1 | |||
| Middle Layer | Polypropylene | ||
| non-woven fabric | melt-blown Melt blown polypropylene filter | Similar | |
| Note 1 | |||
| Inner Facing Layer | Spun-bond | ||
| non-woven fabric | polypropylene Spun-bond polypropylene | Similar | |
| Note 1 | |||
| Nose Clip | Iron wire coated | ||
| polypropylene | with Malleable aluminum wire | Similar | |
| Note 1 | |||
| Ear Loop/Headband | 20% Spandex 80% Polyester | Polyester | Similar |
| Note 1 | |||
| Design Features | |||
| Style | Flat pleated | Flat pleated | Same |
| Multiple Layers | 3 Layers | 3 Layers | Same |
| Single Use | Single use | Single use | Same |
| Sterility | |||
| Sterile | Non-sterile | Non-sterile | Same |
| Dimension | |||
| Length Width | 173mm X 97mm | 175mm X 95mm | Different |
| Note 2 | |||
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 2 | |||
| Fluid Resistance | |||
| ASTM F1862 | Pass at 120mmHg | Pass at 120mmHg | Similar |
| Particulate Filtration | |||
| Efficiency (PFE) | |||
| ASTM F2299 | Pass at >98% | Pass at >98% | Similar |
| Bacterial Filtration | |||
| Efficiency (BFE) | |||
| ASTM F2101 | Pass at >98% | Pass at >98% | Similar |
| Differential Pressure | |||
| (Delta P) | |||
| MIL-M-36954C | Pass at |