(155 days)
No
The device is a standard surgical face mask and the summary describes only physical and filtration properties, with no mention of AI or ML.
No.
The device (a face mask) is intended to provide protection against the transfer of microorganisms, body fluids, and particulate material, which is a preventive function, not a therapeutic one.
No
The device description and intended use clearly state that it is a surgical mask for protection and infection control, not for diagnosis.
No
The device description and performance studies clearly indicate a physical, disposable face mask, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Description and Intended Use: The provided text clearly describes a face mask intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier device used on the body, not a device used to test samples from the body.
- Performance Studies: The performance studies listed (resistance to penetration, filtration efficiency, differential pressure, flammability, biocompatibility) are all relevant to the physical barrier and protective properties of a face mask, not to the analytical performance of a diagnostic test.
The device described is a surgical mask, which is a type of personal protective equipment (PPE) used in healthcare settings. It falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The device 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.
Product codes
FXX
Device Description
The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, single-use, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-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
Not Found
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 Testing:
Resistance to Penetration by Synthetic blood (ASTM F1862/F1862M-17): Pass at 120mmHg.
Bacterial Filtration Efficiency (ASTM F2101-2019): Average 98.61% (Acceptance Criteria: >=98%)
Particulate Filtration Efficiency (ASTM F2299/F2299M-03 (2017)): Average 98.58% (Acceptance Criteria: >=98%)
Differential Pressure (EN 14683:2019): Average 4.41 mm H2O/cm² (Acceptance Criteria: =98%
Bacterial filtration level: >=98%
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.
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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.
February 10, 2021
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K202605
Trade/Device Name: Standard Procedure Mask, Standard Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 20, 2020 Received: November 19, 2020
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 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 CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Standard Procedure Mask; Standard Surgical Mask
Indications for Use (Describe)
The device 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.
| 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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K202605
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
-
- Date of Preparation: 01/29/2021
-
- Sponsor Identification
Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
No.217 East Wencheng Road, Economic Development Zone, Siyang, Jiangsu, 223700, China
Contact Person: Shuying An Position: Product Manager Tel: +86-527-80300123 Fax: +86-527-80300123 Email: zongzhu@medplusgroup.com
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
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 Devices
Trade Name: Standard Procedure Mask; Standard Surgical 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 device 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.
Device Description:
The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.
- Identification of Predicate Device
510(k) Number: K153496 Product Name: Disposable Surgical Face Mask
- Summary of Non-Clinical Testing
The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.
| Name of the Test
| Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Resistance to Penetration | |||
| by Synthetic blood | |||
| ASTM F1862/F1862M-17 | |||
| Standard Test Method for | The test was performed in accordance with ASTM F1862-17 Standard Test Method for Resistance of | No penetration at 120 mmHg | Pass at 120mmHg |
| Resistance of Medical | Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) to evaluate the effectiveness of the test sample from possible exposure to blood and other body fluids | ||
| Bacterial Filtration | |||
| Efficiency | |||
| 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 | The test was performed in accordance with 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 to | |||
| determine the bacterial | |||
| filtration efficiency (BFE) of | |||
| the test article. | $\ge98%$ | Average 98.61% | |
| Particulate Filtration | |||
| Efficiency | |||
| 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 | The test was performed in accordance with ASTM | ||
| F2299-03 (Reapproved |
- Standard Test Method
for Determining the Initial
Efficiency of Materials Used
in Medical Face Masks to
Penetration by Particulates
Using Latex Spheres, to
determine the Particle
Filtration Efficiency. | $\ge98%$ | Average 98.58% |
| Differential Pressure
EN 14683:2019 Medical
face masks- Requirements
and test methods | The test was performed in accordance with EN
14683:2019 Medical face
masks-Requirements and test
methods, to determine the
differential pressure. | $