(210 days)
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.
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.
This document describes the non-clinical testing performed for the HKZ-01 Surgical Mask (subject device) to demonstrate its substantial equivalence to a legally marketed predicate device (Surgical Face Mask, K202843).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | Verify the fluid resistance meets ASTM F2100 Level 2 requirements | 32 Out of 32 pass at 120 mmHg | Pass |
| 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 Class 16 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 | < 6.0 mmH20/cm² | Pass |
| ASTM F2100 Level 2 ASTM F2100 | Verify all ASTM F2100 Level 2 requirements are met | Meets requirements at Level 2 | Pass |
| Biocompatibility Skin Irritation ISO 10993-10 | Verify the device is non-irritating under ISO 10993-10 testing | Under the conditions of the study, non-irritating | Pass |
| Biocompatibility Skin Sensitization ISO 10993-10 | Verify the device is not a sensitizer under ISO 10993-10 testing | Under the conditions of the study, non-sensitizing | Pass |
| Biocompatibility Cytotoxicity ISO 10993-5 | Verify the device is not cytotoxic under ISO 10993-5 testing | Under the conditions of the study, non-cytotoxic | Pass |
| EO/ECH Residues ISO 10993-7 | Verify low levels of sterilant residuals | EO ≤ 4mg/device, ECH ≤ 9mg/device | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Three nonconsecutive lots were tested to demonstrate that the subject device met the standard and the test methodology." (Page 4) Specific sample numbers for each test (e.g., how many masks were tested for fluid resistance) are not provided.
- Data Provenance: Not explicitly stated as country of origin, but the submission is from Nanjing 3H Medical Products Co., Ltd., China. The tests are non-clinical, likely conducted in a laboratory setting. The data is retrospective in the sense that these tests were conducted on completed products prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the tests are non-clinical, performance-based tests, not requiring expert ground truth for interpretation. The ground truth is defined by the established industry standards (e.g., ASTM, ISO).
4. Adjudication Method for the Test Set
- This information is not applicable as the tests are non-clinical, objective measurements against defined standards, not requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "No clinical testing was included in this submission." (Page 5)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a surgical mask, not an algorithm or AI-powered system. The testing performed is physical and biological performance testing of the mask itself.
7. The Type of Ground Truth Used
- The ground truth for these non-clinical tests is established by objective, quantitative performance criteria defined by recognized national and international standards such as ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR 1610, ASTM F2100-19, and ISO 10993 (various parts).
8. The Sample Size for the Training Set
- This information is not applicable as this is a physical medical device (surgical mask), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as this is a physical medical device (surgical mask) and does not involve a training set.
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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 ofComparison | 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 polypropyleneMiddle layer: Melt blown polypropylene filterInner facing layer: Spun-bond polypropyleneNose clip: Polypropylene and galvanized iron wireEar loops: Nylon and spandex | Outer facing layer: Spun-bond polypropyleneMiddle layer: Melt blown polypropylene filterInner facing layer: Spun-bond polypropyleneNose clip: Polypropylene and galvanized iron wireEar 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 OxideISO 11135 | Ethylene OxideISO 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 | AcceptanceCriteria | Result |
|---|---|---|---|
| Fluid ResistanceASTM F1862 | Verify the fluid resistancemeets ASTM F2100 Level 2 | 32 Out of 32 passat 120 mmHg | Pass |
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| requirements | |||
|---|---|---|---|
| Particulate FiltrationEfficiencyASTM F2299 | Verify the particulate filtrationefficiency meets ASTM F2100Level 2 requirements | ≥ 98% | Pass |
| BacterialFiltration EfficiencyASTM F2101 | Verify the bacterial filtrationefficiency meets ASTM F2100Level 2 requirements | ≥ 98% | Pass |
| Flammability Class16CFR 1610 | Verify the flammability meetsClass 1 requirements | Class 1 | Pass |
| DifferentialPressure (Delta-P)ASTM F2100-19 | Verify the differentialpressure meets ASTM F2100Level 2 requirements | < 6.0 mmH20/cm² | Pass |
| ASTM F2100Level 2 ASTM F2100 | Verify all ASTM F2100 Level 2requirements are met | Meets requirementsat Level 2 | Pass |
| Biocompatibility SkinIrritation ISO 10993-10 | Verify the device is non-irritating under ISO 10993-10testing | Under the conditionsof the study, non-irritating | Pass |
| Biocompatibility SkinSensitization ISO10993-10 | Verify the device is not asensitizer under ISO 10993-10testing | Under the conditionsof the study, non-sensitizing | Pass |
| BiocompatibilityCytotoxicity ISO-10993-5 | Verify the device is notcytotoxic under ISO 10993-5testing | Under the conditionsof the study, non-cytotoxic | Pass |
| EO/ECH ResiduesISO 10993-7 | Verify low levels of sterilantresiduals | EO ≤ 4mg/deviceECH ≤ 9mg/device | Pass |
8. Clinical Testing
No clinical testing was included in this submission.
9. Conclusion
The conclusions from the nonclinical testing demonstrate that the HKZ-01 Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Surgical Face Mask (K202843).
§ 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.