(210 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.
The device (surgical mask) is intended to protect against the transfer of microorganisms, blood, and body fluids, and particulate materials, which is a protective function rather than a therapeutic one (treating or curing a condition).
No
Explanation: This device is a surgical mask, clearly described as having the intended use of physically protecting against the transfer of microorganisms, blood, and body fluids. It does not analyze, detect, or provide information about a patient's health condition, which are characteristic functions of a diagnostic device.
No
The device description clearly outlines physical components (Spunbond Polypropylene, Melt Blown Polypropylene Filter, ear loops, nose clip) and performance testing related to material properties and physical characteristics, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the surgical mask's purpose is to act as a physical barrier to protect against the transfer of microorganisms, blood, body fluids, and particulate materials. It is worn on the face and mouth.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. Its function is external and protective.
- Intended Use: The intended use focuses on protection during surgical procedures and general healthcare settings, not on analyzing biological samples for diagnostic purposes.
The information provided about performance studies and key metrics relates to the mask's barrier properties and safety for use on the skin, not to the accuracy of a diagnostic test.
N/A
Intended Use / Indications for Use
The Surgical Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Product codes
FXX
Device Description
Medical surgical mask is Sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided Sterile.
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
operating room personnel and other general healthcare workers
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 testing was performed across three nonconsecutive lots to demonstrate that the subject device met the specified standards. Tests included:
- Fluid Resistance (ASTM F1862): 32 out of 32 samples passed at 120 mmHg, meeting ASTM F2100 Level 2 requirements.
- Particulate Filtration Efficiency (ASTM F2299): Achieved ≥ 98% efficiency, meeting ASTM F2100 Level 2 requirements.
- Bacterial Filtration Efficiency (ASTM F2101): Achieved ≥ 98% efficiency, meeting ASTM F2100 Level 2 requirements.
- Flammability (CFR 1610): Met Class 1 requirements.
- Differential Pressure (Delta-P) (ASTM F2100-19): Less than 6.0 mmH2O/cm², meeting ASTM F2100 Level 2 requirements.
- ASTM F2100 Level 2: All requirements met at Level 2.
- Biocompatibility Skin Irritation (ISO 10993-10): Non-irritating under the conditions of the study.
- Biocompatibility Skin Sensitization (ISO 10993-10): Non-sensitizing under the conditions of the study.
- Biocompatibility Cytotoxicity (ISO 10993-5): Non-cytotoxic under the conditions of the study.
- EO/ECH Residues (ISO 10993-7): EO ≤ 4mg/device, ECH ≤ 9mg/device, verifying low levels of sterilant residuals.
All tests passed, demonstrating that the device is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance: 32 Out of 32 pass at 120 mmHg
- Particulate Filtration Efficiency: ≥ 98%
- Bacterial Filtration Efficiency: ≥ 98%
- Flammability: Class 1
- Differential Pressure (Delta-P):
§ 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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November 24, 2021
Nanjing 3H Medical Products Co., Ltd. Chun Yang Technology Department Manager No.5 Zhushan Road Gaochun County Economic Development Zone Nanjing, Jiangsu 211300 China
Re: K211295
Trade/Device Name: Surgical Mask (sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 21, 2021 Received: October 22, 2021
Dear Chun Yang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
Yongqing Chen Date: 2021.11.24 14:38:23 -05'00' -S
For Clarence Murray III 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 (if known) K211295
Device Name Surgical mask (sterile)
Indications for Use (Describe)
The Surgical Mask is intended for single use by operating room persomel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
| 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 K211295
Submitter Information 1.
Company Name: Nanjing 3H Medical Products Co., Ltd. Establishment Registration Number: K211295 Address: No.5 Zhushan Road Gaochun County Economic Development Zone Nanjing Jiangsu, CHINA 211300 Phone: +86-25-57885555 Contact Person: Chun Yang (Technology Department manager) E-mail: rdc(@3hmedical.com Date prepared: November 23, 2021
2. Subject Device Information
Type of 510(k) submission: Traditional Common Name: Surgical Mask Trade Name: Surgical mask (sterile) Model: HKZ-01 Product Code: FXX Regulation Number: 21 CFR 878.4040
3. Predicate Device Information
Submitter: B.J.ZH.F.Panther Medical Equipment Co., Ltd Common Name: Surgical Face Mask Trade Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) 510(k) number: K202843 Product Code: FXX Regulation Number: 21 CFR 878.4040
4. Device Description
Medical surgical mask is Sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided Sterile.
5. Indications for Use
- The Surgical Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
6. Comparison of Technological Characteristics with the Predicate Device
Table 1 - General Comparison
| Elements of
| Comparison | Subject Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Product Name | Surgical Mask (sterile) | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | - | |
| 510(k) Number | K211295 | K202843 | - | |
| General Comparison | ||||
| Prescription/Over-the-counter use | Over-the-counter use | Over-the-counter use | Same | |
| The Surgical Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | Same | ||
| Type | 3 Ply, Ear Loops, Flat-Pleated Style | 3 Ply, Ear Loops, Flat-Pleated Style | Same | |
| Material | Outer facing layer: Spun-bond polypropylene | |||
| Middle layer: Melt blown polypropylene filter | ||||
| Inner facing layer: Spun-bond polypropylene | ||||
| Nose clip: Polypropylene and galvanized iron wire | ||||
| Ear loops: Nylon and spandex | Outer facing layer: Spun-bond polypropylene | |||
| Middle layer: Melt blown polypropylene filter | ||||
| Inner facing layer: Spun-bond polypropylene | ||||
| Nose clip: Polypropylene and galvanized iron wire | ||||
| Ear loops: Nylon and spandex | Same | |||
| Color | Blue | Blue | Same | |
| Dimension (Width) | $9.5cm \pm 0.4cm$ | $9.5cm$ | Similar | |
| Dimension (Length) | $17.5cm \pm 0.4cm$ | $17.5cm$ | Same | |
| Sterility | Sterile | Sterile/Non-sterile | Different | |
| Sterilization Method | Ethylene Oxide | |||
| ISO 11135 | Ethylene Oxide | |||
| ISO 11135 | Same | |||
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
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7. Summary of Non-Clinical Testing
Provided below is the nonclinical testing for the subject device. Three nonconsecutive lots were tested to demonstrate that the subject device met the standard and the test methodology.
| Test Method | Purpose | Acceptance
Criteria | Result |
|--------------------------------|---------------------------------------------------------|----------------------------------|--------|
| Fluid Resistance
ASTM F1862 | Verify the fluid resistance
meets ASTM F2100 Level 2 | 32 Out of 32 pass
at 120 mmHg | Pass |
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| requirements | |||
|---|---|---|---|
| Particulate Filtration | |||
| Efficiency | |||
| ASTM F2299 | Verify the particulate filtration | ||
| efficiency meets ASTM F2100 | |||
| Level 2 requirements | ≥ 98% | Pass | |
| Bacterial | |||
| Filtration Efficiency | |||
| ASTM F2101 | Verify the bacterial filtration | ||
| efficiency meets ASTM F2100 | |||
| Level 2 requirements | ≥ 98% | Pass | |
| Flammability Class16 | |||
| CFR 1610 | Verify the flammability meets | ||
| Class 1 requirements | Class 1 | Pass | |
| Differential | |||
| Pressure (Delta-P) | |||
| ASTM F2100-19 | Verify the differential | ||
| pressure meets ASTM F2100 | |||
| Level 2 requirements |