(428 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No.
This device is intended to protect against the transfer of microorganisms, blood and body fluids, and particulate materials, rather than to treat, mitigate, or prevent a disease or condition.
No
Explanation: The device is a surgical face mask, which is a barrier device intended to prevent the transfer of microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (polypropylene non-woven cloth, polyurethane, spandex, iron-zinc strip, polyethylene terephthalate) and performance metrics related to material properties and physical barriers, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states the device is a "disposable surgical face mask" intended to "protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials." This is a barrier device, not a device used to analyze specimens from the body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient or user.
- Intended Use: The intended use is for physical protection, not for providing diagnostic information about a patient's health status.
Therefore, based on the provided information, the disposable surgical face mask is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The disposable 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.
Product codes
FXX
Device Description
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop 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 Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. 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
Operating room personnel and other general healthcare workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion 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 F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- 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
- EN 14683:2019 Medical face masks-Requirements and test methods
- CPSC CS-191-53 Flammability Test Method (16 CFR 1610)
- ISO 10993-7:2008 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
Summary of Non-clinical Testing:
Particulates Filtration Efficiency (ASTM F2299/F2299M-03(2017)):
- Ear loop: ≥98% accepted, Passed (3 non-consecutive lots tested, 125/lot sample size). Lot 1: 98.81%, Lot 2: 98.78%, Lot 3: 98.8%.
- Tie-on: ≥98% accepted, Passed (3 non-consecutive lots tested, 125/lot sample size). Lot 1: 98.82%, Lot 2: 98.78%, Lot 3: 98.79%.
Bacterial filtration efficiency (ASTM F2101-19): - Ear loop: ≥98% accepted, Passed (3 non-consecutive lots tested, 125/lot sample size). Lot 1: 99.9%, Lot 2: 99.91%, Lot 3: 99.91%.
- Tie-on: ≥98% accepted, Passed (3 non-consecutive lots tested, 125/lot sample size). Lot 1: 99.91%, Lot 2: 99.9%, Lot 3: 99.91%.
Fluid Resistance (ASTM F1862/F1826M-17): - Ear loop: 120 mmHg accepted, Passed (3 non-consecutive lots tested, 125/lot sample size). No penetration at 120 mmHg for all lots.
- Tie-on: 120 mmHg accepted, Passed (3 non-consecutive lots tested, 125/lot sample size). No penetration at 120 mmHg for all lots.
Differential Pressure (EN 14683:2019): - Ear loop: △P
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2022
Lyncmed Medical Technology (Beijing) Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 China
Re: K212649
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 26, 2022 Received: September 30, 2022
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.
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
1
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 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,
Bifeng Qian, M.D., 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) K212649
Device Name Disposable Surgical Face Mask
Indications for Use (Describe)
The disposable 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.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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: K212649
-
- Date of Preparation: 10/24/2022
-
- Sponsor Identification
Lyncmed Medical Technology (Beijing) Co., Ltd.
Room 1601, Building No.2, Zhubang 2000 Business Building, Balizhuang Xili 99, Chaoyang District, 100022 Beijing, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: 3013678400
Contact Person: Joyce Jiang Position: RA Manager Tel: +86-10-8646 8058 Email: joycejiang@lyncmed.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: Disposable Surgical Face 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 disposable 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.
Device Description:
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop 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 Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
-
న్. Identification of Predicate Device
510(k) Number: K202029 Product Name: Medical Surgical Mask -
- Comparison of Technology with Predicate Device
| ITEM | Proposed Device K212649 | 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 disposable surgical face mask is intended for single use by operating room personnel and | The medical surgical mask is intended for single use by operating room personnel and | Same |
| other general healthcare workers | |||
| to protect both patients and | |||
| healthcare workers against transfer | |||
| of microorganisms, blood and | |||
| body fluids, and particulate | |||
| materials. | other general healthcare workers | ||
| to protect both patients and | |||
| healthcare workers against | |||
| transfer of microorganisms, | |||
| blood and body fluids, and | |||
| particulate materials. | |||
| Mask style | Flat pleated | Flat pleated | Same |
| Mask color | Blue | Blue | Same |
| Design feature | Ear loop or tie-on | Ear loop or tie-on | Same |
| Dimension | 175mm×95 mm | ||
| 165mm×85mm | 175mm×95mm | ||
| 145mm×90mm | |||
| 120mm×70mm | Difference | ||
| Level | Level II | Level II | Same |
| Fluid Resistance | Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate efficiency level | Average 99.9% | Average 98.87% | Difference |
| Bacterial filtration level | Average 99.9% | Average 99.46% | Difference |
| Differential pressure | Average 3.63mmH2O/cm2 | Average 3.72mmH2O/cm2 | Difference |
| 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 | Polyurethane and spandex | Nylon and polyurethane (PU) | Difference |
| Tie strings | PP non-woven cloth | Nylon | |
| Nose clip | Iron, zinc and polyethylene (PE) | ||
| crosslinking material | Iron and polyethylene | ||
| Mask body | 25g/m2 Polypropylene (PP) non- | ||
| woven cloth | 25g/m2 Polypropylene (PP) 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 | EO sterilized | Same |
| SAL | 10-6 | 10-6 | |
| Ethylene oxide residuals | EO ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity |
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- A 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 F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
-
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
-
EN 14683:2019 Medical face masks-Requirements and test methods
-
CPSC CS-191-53 Flammability Test Method (16 CFR 1610)
-
ISO 10993-7:2008 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
7
| No | Item | Test Method/
Standard | Type | Acceptance
Criteria | Results |
|----|------------------------------------------|------------------------------------|----------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Particulates
Filtration
Efficiency | ASTM F2299/
F2299M-
03(2017) | Ear loop | ≥98% | Passed
3 non-consecutive lots tested, using a
sample size of 125/lot
Lot 1: 98.81%
Lot 2: 98.78%
Lot 3: 98.8% |
| | | | Tie-on | ≥98% | Passed
3 non-consecutive lots tested, using a
sample size of 125/lot
Lot 1: 98.82%
Lot 2: 98.78%
Lot 3: 98.79% |
| 2 | Bacterial
filtration
efficiency | ASTM F2101-19 | Ear loop | ≥98% | Passed
3 non-consecutive lots tested, using a
sample size of 125/lot
Lot 1: 99.9%
Lot 2: 99.91%
Lot 3: 99.91% |
| | | | Tie-on | ≥98% | Passed
3 non-consecutive lots tested, using a
sample size of 125/lot
Lot 1: 99.91%
Lot 2: 99.9%
Lot 3: 99.91% |
| 3 | Fluid
Resistance | ASTM F1862/
F1826M-17 | Ear loop | 120 mmHg | Passed
3 non-consecutive lots tested, using a
sample size of 125/lot
Lot 1: No penetration at 120 mmHg
Lot 2: No penetration at 120 mmHg
Lot 3: No penetration at 120 mmHg |
| | | | Tie-on | 120 mmHg | Passed
3 non-consecutive lots tested, using a
sample size of 125/lot
Lot 1: No penetration at 120 mmHg
Lot 2: No penetration at 120 mmHg
Lot 3: No penetration at 120 mmHg |
| 4 | Differential
Pressure | EN 14683:2019 | Ear loop | △P