(116 days)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile. Serial number: ZZ-YYKZ-01, size 175x95mm, Blue ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03.size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black
The proposed device, Surgical Mask is a three-layer, plane bandage type mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The proposed device includes masks in two colors and two sizes, as shown in Table 1. The device is single use and provided sterile.
This document is a 510(k) Summary for a Surgical Mask, submitted to the FDA. It details the non-clinical testing performed to demonstrate that the proposed device is substantially equivalent to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose (from document) | Acceptance Criteria (per ASTM F2100-19) | Reported Device Performance (Blue Mask) | Reported Device Performance (Black Mask) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | Pass at 80 mmHg | 96 out of 96 pass at 80 mmHg | 96 out of 96 pass at 80 mmHg |
| Bacterial filtration efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | ≥95% | Passed at 99.60% | Passed at 99.61% |
| Particulate filtration efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | ≥95% | Passed at 99.14% | Passed at 99.14% |
| Differential pressure (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | <5.0 mmH2O/cm² | <5.0 mmH2O/cm² | <5.0 mmH2O/cm² |
| Flammability (16 CFR 1610) | Verify the flammability of the proposed device can meet the requirements for Level 1 specified in ASTM F2100-19. | Class 1 | Class 1 | Class 1 |
| In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the testing conditions. | Pass | Pass (implied, as results are for "the device") |
| Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the testing conditions. | Pass | Pass (implied, as results are for "the device") |
| Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the testing conditions. | Pass | Pass (implied, as results are for "the device") |
| EO ECH residuals (ISO 10993-7) | Verify the EO ECH residuals of the proposed device can meet the requirements of ISO 10993-7. | The average daily dose of EO to patient shall not exceed 4mg. The average daily dose of ECH to patient shall not exceed 9mg. | Pass | Pass (implied, as results are for "the device") |
| Bacterial Endotoxin (USP <85>) | Verify the bacterial endotoxin of the proposed device can meet the requirements of USP <85>. | Bacterial Endotoxin Levels were below the level of 20 EU/device. | Pass | Pass (implied, as results are for "the device") |
| Package Integrity (ASTM F series) | Verify the package integrity of the proposed device can meet the requirements of ASTM F1886 / F1886M-16, ASTM F88/F88M-15, ASTM F1929-15. | There should be no channel on the package and no damage on device. The maximum seal strength should be no less than 2.0N/15mm. There should be no dye penetration on the package. | Pass | Pass (implied, as results are for "the device") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for performance tests: For Fluid Resistance, Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Differential Pressure, and Flammability, the sample size was "three lots, 32 per lot" for a total of 96 samples per test.
- Data Provenance: The tests were conducted by the submitting company, Guangdong Zhizhen Biological Medical Co., Ltd, which is based in China. The document does not specify if the data is retrospective or prospective, but based on the nature of device testing for 510(k) clearance, it is typically prospective for the purpose of demonstrating performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document describes non-clinical laboratory testing (e.g., physical properties, filtration efficiency, biocompatibility). It does not involve "experts" establishing ground truth in the sense of medical diagnosis or interpretation of images. The "ground truth" is established by adherence to standardized test methods (e.g., ASTM, ISO, EN standards) and their predefined acceptance criteria. Thus, the expertise lies in the accredited laboratories and personnel performing these specific, standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the study involves standardized laboratory testing against specific criteria, not human interpretation or adjudication of cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for AI/imaging devices, not for a surgical mask.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a physical surgical mask, not an algorithm. The performance tests are for the physical properties of the mask (e.g., filtration, fluid resistance).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these tests is defined by established international standards and regulations (e.g., ASTM F2100-19, ISO 10993 series, EN 14683, 16 CFR 1610, USP <85>). The performance of the device is measured against the quantitative and qualitative acceptance criteria specified in these standards.
8. The sample size for the training set
- This is not applicable. The submission describes non-clinical testing of a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable, as there is no training set for a physical device like a surgical mask.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 14, 2022
Guangdong Zhizhen Biological Medical Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K212997
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: October 11, 2021 Received: October 15, 2021
Dear Diana Hong:
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,
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) K212997
Device Name Surgical Mask
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile. Serial number: ZZ-YYKZ-01, size 175x95mm, Blue
ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03.size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black
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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K212997
- Date of Preparation: 01/12/2022 1.
-
- Sponsor Identification
Guangdong ZhiZhen Biological Medicine Co., Ltd.
3rd and 4th floors of Building 2 & 1ª and 3nd Building 3, No.5 South Street, Datian First Team, Minzhu Village, Tanbu Town, Huadu District Guangzhou Guangdong, China
Establishment Registration Number: 3015457451
Contact Person: Caiyun Zhou Position: Manager of Regulations Department Tel: +86-20-37713902 Fax: +86-20-37713902 Email: gfpeng@zhizhenmedic.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: +360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Surgical Mask Common Name: Surgical mask
Regulatory Information Classification Name: Mask, Surgical; Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040; Review Panel: General Hospital;
Indication for use:
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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 sterile.
Serial number: ZZ-YYKZ-01, size 175x95mm, Blue
ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03, size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black
Device Description:
The proposed device, Surgical Mask is a three-layer, plane bandage type mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The proposed device includes masks in two colors and two sizes, as shown in Table 1. The device is single use and provided sterile.
| Serial number | Length (mm) | Width (mm) | Color |
|---|---|---|---|
| ZZ-YYKZ-01 | 175 | 95 | Blue |
| ZZ-YYKZ-02 | 145 | 95 | Blue |
| ZZ-YYKZ-03 | 175 | 95 | Black |
| ZZ-YYKZ-04 | 145 | 95 | Black |
Table 1 Product Model
ર. Identification of Predicate Device
Predicate Device:
510(k) Number: K202905 Product Name: Disposable Face Mask
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Technological Characteristic Comparison Table 6.
| Table 1 Comparison of Surgical Mask | ||||
|---|---|---|---|---|
| ITEM | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Product Code | FXX | FXX | same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | same | |
| Class | II | II | same | |
| Indication for Use | The surgical mask is intended to be worn toprotect both the patient and healthcarepersonnel from transfer of microorganisms,body fluids and particulate material. Thesemasks are intended for use in infectioncontrol practices to reduce the potentialexposure to blood and body fluids. This is asingle use, disposable device, providedsterile.Serial number: ZZ-YYKZ-01, size175x95mm, BlueZZ-YYKZ-02, size 145x95mm, BlueZZ-YYKZ-03, size 175x95mm, BlackZZ-YYKZ-04, size 145x95mm, Black | The Disposable Face Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids, andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. | different | |
| Configuration | ear strapnose clipmask body | ear strapnose clipmask body | same | |
| Mask color | Blue, Black | Blue | different | |
| Dimension | 17.5×9.5 cm14.5×9.5 cm | 14.5×9.5cm,17.0×9.5cm,17.5×9.5cm | different | |
| Level | Level I | Level I | same | |
| Fluid Resistance | Pass at 80mmHg | Pass at 80mmHg | same | |
| Particulate efficiencylevel | Blue: Passed at 99.14%Black: Passed at 99.14 % | ≥95% | different | |
| Bacterial filtrationlevel | Blue: Passed at 99.60%Black: Passed at 99.61 % | ≥95% | different | |
| Differential pressure | <5 mmH2O/cm² | <5mmH2O/cm² | same | |
| Flammability | Class 1 | Class 1 | same | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | same | |
| Patient Contacting Material | ||||
| Ear strap | Polyamide and Polyurethane | Spandex and Polyester | different | |
| Nose clip | Polyethylene terephthalate and Iron | HDPE and Iron | different | |
| Maskbody | Outermaterial | Polypropylene nonwoven fabric | PP meltblown non-woven cloth | |
| Middlematerial | Polypropylene melt-blown cloth | PP spunbond non-woven cloth | ||
| Innermaterial | Polypropylene nonwoven fabric | PP spunbond non-woven cloth | ||
| Biocompatibility | ||||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | same | |
| Sensitization | No Sensitization | No Sensitization | same | |
| Irritation | No Irritation | No Irritation | same | |
| Sterilization | ||||
| Method | EO sterilized | Non-sterile | different | |
| SAL | 10-6 | / |
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Different Analysis 1- Indication for Use The proposed device and predicate devices have essentially same indications for use.
Different Analysis 2- Color The color of the proposed device is different from the predicate device.
Different Analysis 3- Dimension The dimension for the proposed device is similar to the predicate device,
Different Analysis 4-Particulate efficiency level The test result for particulate efficiency for the proposed device is different from predicate device.
Different Analysis 5-Bacterial filtration level The test result for bacteria efficiency for the proposed device is different from predicate device.
Different Analysis 6-Patient Contacting Material The patient contact material for the propose device is different from predicate device.
Different Analysis 7-Sterilezation
The final product status of the proposed device is different from predicate device,
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7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications and the acceptance criteria in the standard and test methodology. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ASTM F1862/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)
-
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
-
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
16 CFR 1610 Standard for the Flammability of Clothing Textiles Corrections
-
EN14683 Medical face masks-Requirements and test methods
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The results of performance tests, biocompatibility test, conducted on the Surgical Mask demonstrate that the device met the specification and the acceptance criteria. A summary of the tests performed is provided in the table below:
| Test | Purpose | AcceptanceCriteria per ASTMF2100-19 | Results(Statistics of three lots,32 per lot) | |
|---|---|---|---|---|
| Blue | Black | |||
| Fluid Resistance(ASTM F1862) | Verify the fluid resistance of theproposed device can meet therequirements for Level 1specified in ASTM F2100-19. | Pass at 80 mmHg | 96 out of 96pass at 80mmHg | 96 out of 96pass at 80mmHg |
| Bacterial filtrationefficiency (BFE)(ASTM F2101) | Verify the bacterial filtrationefficiency of the proposed devicecan meet the requirements forLevel 1specified in ASTM F2100-19. | ≥95% | Passed at99.60% | Passed at99.61% |
| Particulatefiltrationefficiency (PFE)(ASTM F2299) | Verify the particulate filtrationefficiency of the proposed devicecan meet the requirements forLevel 1specified in ASTM F2100-19. | ≥95% | Passed at99.14% | Passed at99.14% |
| Differentialpressure(EN 14683) | Verify the differential pressure ofthe proposed device can meet therequirements for Level 1specified in ASTM F2100-19. | <5.0mmH2O/cm² | <5.0mmH2O/cm² | <5.0mmH2O/cm² |
| Flammability(16 CFR 1610) | Verify the flammability of theproposed device can meet therequirements for Level 1specified in ASTM F2100-19. | Class 1 | Class 1 | Class 1 |
| Table 2 Performance Testing | |
|---|---|
| ----------------------------- | -- |
Table 3 Biocompatibility Testing
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| In vitro Cytotoxicity(ISO 10993-5) | Verify that the proposed device extract isnon-cytotoxic. | The extract is non-cytotoxicunder the testing conditions. | Pass |
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| Skin Irritation(ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the testing conditions. | Pass |
|---|---|---|---|
| Skin Sensitization(ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the testing conditions. | Pass |
Table 4 Sterilization
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| EO ECH residuals(ISO 10993-7) | Verify the EO ECH residualsof the proposed device canmeet the requirements of ISO10993-7. | The average daily dose of EO topatient shall not exceed 4mg.The average daily dose of ECHto patient shall not exceed 9mg. | Pass |
| Bacterial Endotoxin(USP <85>) | Verify the bacterial endotoxinof the proposed device canmeet the requirements of USP<85>. | Bacterial Endotoxin Levelswere below the level of 20EU/device | Pass |
| Package Integrity(ASTM F1886 /F1886M-16, ASTMF88/F88M-15,ASTM F1929-15) | Verify the package integrity ofthe proposed device can meetthe requirements of ASTMF1886 / F1886M-16, ASTMF88/F88M-15,ASTMF1929-15. | There should be no channel on thepackage and no damage on device.The maximum seal strengthshould be no less than2.0N/15mm.There should be no dyepenetration on the package | Pass |
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in the 510(k) submission, the Surgical Masks are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K202905.
§ 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.