(116 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, a surgical mask, is intended to protect from the transfer of microorganisms, body fluids, and particulate material, rather than directly treat a disease or condition.
No
A surgical mask is used to protect from transfer of microorganisms and body fluids, not to diagnose a condition.
No
The device description clearly states it is a physical surgical mask made of three layers with ear straps and a nose clip, and the performance studies are based on physical properties and biological tests, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask, which is consistent with a barrier device.
- Lack of Diagnostic Elements: There is no mention of any components or processes that would be used to test samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the mask's ability to filter particles, resist fluids, and its biocompatibility – all characteristics of a protective barrier, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This surgical mask does not perform any such function.
N/A
Intended Use / Indications 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 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
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
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 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
The results of performance tests, biocompatibility test, conducted on the Surgical Mask demonstrate that the device met the specification and the acceptance criteria.
Performance Testing (Statistics of three lots, 32 per lot):
- Fluid Resistance (ASTM F1862): Blue: 96 out of 96 pass at 80 mmHg; Black: 96 out of 96 pass at 80 mmHg. (Acceptance Criteria: Pass at 80 mmHg)
- Bacterial filtration efficiency (BFE) (ASTM F2101): Blue: Passed at 99.60%; Black: Passed at 99.61%. (Acceptance Criteria: >=95%)
- Particulate filtration efficiency (PFE) (ASTM F2299): Blue: Passed at 99.14%; Black: Passed at 99.14%. (Acceptance Criteria: >=95%)
- Differential pressure (EN 14683): Blue: ): Result Pass. (Acceptance Criteria: Bacterial Endotoxin Levels were below the level of 20 EU/device)
- Package Integrity (ASTM F1886 / F1886M-16, ASTM F88/F88M-15, ASTM F1929-15): Result Pass. (Acceptance Criteria: 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)
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance: 96 out of 96 pass at 80 mmHg for both blue and black masks.
Bacterial filtration efficiency (BFE): Blue: 99.60%, Black: 99.61%.
Particulate filtration efficiency (PFE): Blue: 99.14%, Black: 99.14%.
Differential pressure:
§ 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.
0
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.
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); 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
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
5
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 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 | The Disposable Face Mask is | |||
| 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 non-sterile. | different | |||
| Configuration | ear strap | |||
| nose clip | ||||
| mask body | ear strap | |||
| nose clip | ||||
| mask body | same | |||
| Mask color | Blue, Black | Blue | different | |
| Dimension | 17.5×9.5 cm | |||
| 14.5×9.5 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 efficiency | ||||
| level | Blue: Passed at 99.14% | |||
| Black: Passed at 99.14 % | ≥95% | different | ||
| Bacterial filtration | ||||
| level | Blue: Passed at 99.60% | |||
| Black: Passed at 99.61 % | ≥95% | different | ||
| Differential pressure | 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
8
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 | Acceptance
Criteria per ASTM
F2100-19 | Results
(Statistics of three lots,
32 per lot) | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------------------------------|------------------------------------|
| | | | Blue | Black |
| 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. | ) | Verify the bacterial endotoxin
of the proposed device can
meet the requirements of USP
. | Bacterial Endotoxin Levels
were below the level of 20
EU/device | Pass |
| Package Integrity
(ASTM F1886 /
F1886M-16, ASTM
F88/F88M-15,
ASTM F1929-15) | 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 |
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
10
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.