(111 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device is described as a "Surgical Face Mask" intended for protection against the 'transfer of microorganisms, blood and body fluids, and particulate materials', which indicates a protective, not a therapeutic function.
No
The device, a surgical face mask, is described as intended for protection against the transfer of microorganisms, blood, and body fluids, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (three-layer mask, non-woven cloth, tie strings/ear loops, nosepiece, nose clip) and performance studies focus on physical properties and biological safety, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, blood, body fluids, and particulate materials. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical components of a mask designed for physical protection.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health, diagnose a condition, or monitor treatment.
- Performance Studies and Metrics: The performance studies and key metrics focus on the physical and biological barrier properties of the mask (filtration, pressure, flammability, biocompatibility), not on diagnostic accuracy or analytical performance related to biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
The Surgical Face Mask is intended for single use by operation 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
The proposed device, Surgical Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in 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
operation 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 tests, including biological tests and performance tests, has been performed on the proposed device according to the following standards:
- ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials
- ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- 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 A Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
- ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- EN 14683:2019 Medical face mask- Requirements and test methods- Annex C Method for determination of breathability (differential pressure)
All test results of non-clinical tests showed that the device passed the acceptance criteria for:
- In Vitro Cytotoxicity Test: No Cytotoxicity Observed
- Skin Sensitization Test: No Skin Sensitization Observed
- Skin irritation Test: No Skin irritation Observed
- Bacterial Filtration: Level 2: >98% (MIN: 98.99%, 98.46%, 98.36%; AVG: 99.53%, 99.10%, 99.2%)
- Differential Pressure: Level 2: 98% (MIN: 98.99%, 98.30%, 98.45%; AVG: 99.58%, 99.25%, 99.11%)
- Resistance to Penetration: Level 2: 120 mmHg (Pass at 120 mmHg for all lots)
- Seal strength of immediate package: >= 2N/15mm (MIN: 2.2, 3.2, 2.2; AVG: 3.04, 3.54, 2.9)
- Seal leak of immediate package: No apparent solution channel through the whole seal edge in the whole seal area (No for all lots)
- EO ECH Residue: EO residue
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
June 14, 2021
Shandong Haidike Medical Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K210518
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 10, 2021 Received: May 13, 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.
For 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) K210518
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical Face Mask is intended for single use by operation 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.
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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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: K210518
-
- Date of Preparation: 05/10/2021
-
- Sponsor Identification
Shandong haidike Medical Products Co.,Ltd.
Tianfu Road, Dongcheng District, Shan County, 274300 Heze City, Shandong Province, China.
Establishment Registration Number: 3016426842.
Contact Person: Lili Xu Position: Registration Manager Tel: +86-530-4660062 Fax: +86 530 4660055 Email: registration@suturescn.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (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
- Identification of Proposed Device 4. Trade Name: Surgical Face Mask Common Name: Surgical Face 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 Face Mask is intended for single use by operation 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.
Device Description:
The proposed device, Surgical Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in sterile.
- న. Identification of Predicate Device
510(k) Number: K202029
Product Name: Medical Surgical Mask
6. Non-Clinical Test Conclusion
Non clinical tests, including biological tests and performance tests, has been performed on the
proposed device according to the following standards:
- A ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
-
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- A 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);
5
- ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of A Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
-
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
EN 14683:2019 Medical face mask- Requirements and test methods- Annex C Method for determination of breathability (differential pressure)
And all the test results of non-clinical tests are summarized in the following table:
| Test/Purpose | Test Method/
Standard | Acceptance Criteria | Result |
|----------------------------|--------------------------|-----------------------------------------------------------|----------------------------------------|
| In Vitro Cytotoxicity Test | ISO 10993-5: 2009 | Reduction of cell viability shall be not more than 30%. | Passed: No Cytotoxicity Observed |
| Skin Sensitization Test | ISO 10993-10: 2010 | The skin reactions grades shall be less than 1. | Passed: No Skin Sensitization Observed |
| Skin irritation Test | ISO 10993-10: 2010 | The irritation response category shall be slight or less. | Passed: No Skin irritation Observed |
Table 1 Summary of Biocompatibility Test Results
Table 2 Summary of Performance Testing
| Performance
Test/ Purpose | Test
Standard | Acceptance Criteria | Test Results | | |
|------------------------------|------------------|-----------------------------|------------------------|------------------------|------------------------|
| | | | Lot #1 | Lot #2 | Lot #3 |
| Bacterial | ASTM F2101-2019 | Level 2: >98% | MIN:
98.99% | MIN:
98.46% | MIN:
98.36% |
| Filtration | | | AVG:
99.53% | AVG:
99.10% | AVG:
99.2% |
| | | | | | |
| Differential
Pressure | EN 14683 Annex C | Level 2: 98% | 98.99%
AVG:
99.58% | 98.30%
AVG:
99.25% | 98.45%
AVG:
99.11% |
| Resistance to
Penetration | ASTM
F1862/F1862M-17 | Level 2: 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg |
| Seal strength of
immediate
package | ASTM
F88/F88M-15 | Seal strength $\ge$ 2N/15mm | MIN: 2.2
AVG: 3.04 | MIN: 3.2
AVG: 3.54 | MIN: 2.2
AVG: 2.9 |
| Seal leak of
immediate
package | ASTM F1929-15 | No apparent solution channel through the whole seal edge in the whole seal area | No | No | No |
| EO
ECH
Residue | ISO 10993-7:2008 | EO residue $\le$ 4mg/device
ECH residue $\le$ 9mg/device | EO Residue:
0.01
mg/device
ECH
Residue:
0.0053
mg/device | EO Residue:
0.0053
mg/device
ECH
Residue:
0.0027
mg/device | EO Residue:
0.006
mg/device
ECH
Residue:
0.01
mg/device |
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
- Summary of Technological characteristics
Table 1 General Comparison | ||
---|---|---|
| ITEM | Proposed Device | Predicate Device
K202029 | 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 Face Mask is
intended for single use by
operation room personnel and
other general healthcare workers
to protect both patients and
healthcare workers against
transfer of microorganisms, | The medical 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, | Same | |
| | blood and body fluids, and
particulate materials. | blood and body fluids, and
particulate materials. | | |
| Mask style | Flat pleated | Flat pleated | Same | |
| Mask Color | Blue | Blue | Same | |
| Design feature | Ear loops or tie-on | Ear loops or tie-on | Same | |
| Dimensions (mm) | Mask body: 175mm*95mm
Ear loops: 180mm
Ear strings: 380mm
Nose clip: 101mm
Tolerance: ±5% | Mask body: 175mm×95mm
(Tolerance: ±1mm)
Ear loops: (2.5-3)mm×200mm
Ear strings: 90mm×9mm
Nose clip: 100mm×(2.5-3.5)mm
Mask body: 145mm×90mm
(Tolerance: ±1mm)
Ear loops: (2.5-3)mm×160mm
Ear strings: 80mm×9mm
Nose clip: 80mm×(2.5-3.5)mm
Mask body: 120mm×70mm
(Tolerance: ±1mm)
Ear loops: (2.5-3)mm×140mm
Ear strings: 70mm×9mm
Nose clip: 70mm×(2.5-3.5)mm
Tolerance: ±1mm | Similar 1 | |
| | ASTM F2100 Level | Level 2 | Level 2 | Same |
| | Performance | | | |
| | Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Same |
| | Particulate efficiency level | Average 99.19% | Average 98.87% | Similar 2 |
| Bacterial filtration level | Average 99.23% | Average 99.46% | Similar 3 | |
| Differential pressure | Average 3.81 mmH2O/cm² | Average 3.72mmH2O/cm² | Similar 4 | |
| 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 Loops | Spandex, nylon | Nylon and PU | Similar 5 | |
| Nose clip | Polyethylene, galvanized wire | Iron strip covered by
polypropylene covering | Similar 6 | |
| Mask body | 25g/m² PP non-woven cloth | 25g/m² PP non-woven cloth | Same | |
| Biocompatibility | | | | |
| Sensitization | No Sensitization | No Sensitization | Same | |
| Irritation | No Irritation | No Irritation | Same | |
| Sterilization | | | | |
| Method | EO sterilized | EO sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
7
8
Similar 1-Dimensions
The dimensions of proposed device are different from the predicate device. However, the dimensions of the proposed device are similar with the largest specification of the predicate device, and performance test result of the propose device can meet the requirements of level 2 mask according to the ASTM F2100-19. This difference does not affect intended use and will not raise any safety issues. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.
Similar 2-Particulate efficiency level
The particulate efficiency level of the proposed device is different from predicate device. However, the test result of the propose device can meet the requirements of level 2 mask according to the ASTM F2100-19. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.
Similar 3-Bacterial filtration level
The bacterial filtration level for the proposed device is different from predicate device. However the test result of the proposed device can meet the requirements of level 2 mask according to the ASTM F2100-19. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.
Similar 4-Differential pressure
The differential pressure of the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask according to the ASTM F2100-19. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.
Similar 5-Ear loops
The material of ear loops for the proposed device is partly different from predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, this difference does not affect substantially equivalence between the proposed
9
device and predicate device.
Similar 6- Nose clip
The material of the Nose clip for proposed device is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, this difference does not affect substantially equivalence between the proposed device and predicate device.
-
- Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device K202029.
- Conclusion