(162 days)
No
The document describes a standard surgical face mask with no mention of AI or ML technology in its design, function, or performance evaluation.
No
The device is a surgical face mask designed to protect from the transfer of microorganisms, body fluids, and particulate material, not to treat a disease or condition.
No
The device description, intended use, and performance studies all indicate that the device is a surgical face mask designed for barrier protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines a physical product made of nonwoven materials with specific filtration properties and ear loops or tie straps. The performance studies and key metrics relate to the physical characteristics and barrier function of the mask, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical face masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical structure and materials of the mask, emphasizing its filtering capabilities. There is no mention of reagents, assays, or any components used to analyze biological samples for diagnostic purposes.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical and barrier properties of the mask (filtration efficiency, pressure, flammability, resistance to penetration) and biocompatibility. These are relevant to a protective device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the device functions as a physical barrier for protection, which is not the purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surgical face masks are 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 Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use.
The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free.
It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
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)
The following performance data were provided in support of the substantial equivalence determination.
Performance test: Flammability, Bacterial Filtration Efficiency, Different Pressure, Sub-Micron Particle Filtration Efficiency, Resistance to Penetration by synthetic blood.
Biocompatibility: Cytotoxicity, Sensitization, Skin Irritation, Acute systemic toxicity.
Simulated transportation
Level 2 product:
Flammability: Class 1 ASTM F2100 (Pass)
Bacterial Filtration Efficiency: Level 2: >= 98% ASTM F2100 (Pass)
Different Pressure: Level 2: = 98% ASTM F2100 (Pass)
Resistance to Penetration by synthetic blood: Level 2: pass at 120 mmHg ASTM F2100 (Pass)
Cytotoxicity: Grade = 98% ASTM F2100 (Pass)
Different Pressure: Level 3: = 98% ASTM F2100 (Pass)
Resistance to Penetration by synthetic blood: Level 3: pass at 160 mmHg ASTM F2100 (Pass)
Cytotoxicity: Grade
§ 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 contains the logo of the U.S. Food & 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.
January 26, 2022
Foshan Nanhai Plus Medical CO LTD % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K212610
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 21, 2021 Received: December 27, 2021
Dear Olivia Meng:
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 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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Indications for Use
510(k) Number (if known) K212610
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical face masks are 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.
Level 2 Surgical Face Mask Models: Tie strap type: 522-001, 522-003, 522-005 Ear loop type: 522-002, 522-004, 522-006 Level 3 Surgical Face Mask Models: Tie strap type: 533-001, 533-003, 533-005 Ear loop type: 533-002, 533-004, 533-006
| 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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Image /page/3/Picture/0 description: The image shows the logo for Plus Medical. The logo features the letters "PM" in a bold, sans-serif font, with the letters stacked on top of each other. A red swoosh runs horizontally through the letters. Below the letters, the words "PLUS MEDICAL" are written in a smaller, sans-serif font.
K212610
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Foshan Nanhai Plus Medical CO LTD Shijiang Industrial Zone, Shatou, Jiujiang Town, Nanhai, Foshan City, Guangdong, China Phone: +86-757-86914198 Fax: +86-755-27343466
| Primary Contact Person: | Olivia Meng
Regulatory Affairs Manager
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Tel: (+86)-20-6231 6262
Fax: (+86)-20-8633 0253 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact Person: | Suyi Li
Regulatory Affairs Manager
Foshan Nanhai Plus Medical CO LTD
Phone: +86-757-86914198
Fax: +86-755-27343466 |
| Date prepared | Dec 19th , 2021 |
| 2. DEVICE | |
| Device Name: | Surgical face mask |
| Common name: | Mask, Surgical |
| Model: | 522-001, 522-002, 522-003, 522-004, 522-005, 522-006, 533-001, 533-002, 533-003, 533-004, 533-005, 533-006 |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | 2 |
| Product Code: | FXX |
3. PREDICATE DEVICE
K160269, Surgical Face Masks (Ear loops and Tie-on) This predicate has not been subject to a design-related recall.
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Image /page/4/Picture/0 description: The image shows the logo for Plus Medical. The logo features the letters 'PM' in a bold, sans-serif font, with the letters colored in a bright blue. A red swoosh or curved line runs horizontally through the middle of the letters, adding a dynamic element to the design. Below the letters, the words 'PLUS MEDICAL' are written in a smaller, sans-serif font, also in blue.
4. DEVICE DESCRIPTION
The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use.
The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free.
lt is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
| Model# | Ear Type | ASTM F2100 Level |
|---|---|---|
| 522-001 | Tie strap | |
| 522-002 | Ear loop | Level 2 |
| 522-003 | Tie strap | |
| 522-004 | Ear loop | |
| 522-005 | Tie strap | |
| 522-006 | Ear loop | |
| 533-001 | Tie strap | |
| 533-002 | Ear loop | Level 3 |
| 533-003 | Tie strap | |
| 533-004 | Ear loop | |
| 533-005 | Tie strap | |
| 533-006 | Ear loop |
Twelve models are included in this submission, the differences listed below:
Six models including 522-001, 522-002, 522-004, 522-005, 522-005, 522-006 are level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- Bacterial filtration efficiency (BFE) ≥98%
- Sub-micron particle filtration efficiency ≥98%
- Different pressure: 98%
Level 2: > 98%
Level 3: > 99% | Similar | |
| Differential
Pressure | For 3 non-consecutive lots,
32 out of 32 pass.
Level 2: 4.4 mm $H_2O/cm^2$
Level 3: 5.06 mm $H_2O/cm^2$ | Level 1: pass at 2.0 mm $H_2O/cm^2$
Level 2: pass at 1.6 mm $H_2O/cm^2$
Level 3: pass at 2.5 mm $H_2O/cm^2$ | Similar | |
| Sub-Micron
Particle Filtration
Efficiency | For 3 non-consecutive lots,
32 out of 32 pass.
Level 2: average at 99.54%
Level 3: average at 99.67% | Level 1: 99.6%
Level 2: 99.6%
Level 3: 99.7% | Similar | |
| Resistance to
Penetration by
Synthetic Blood | For 3 non-consecutive lots,
≥29 out of 32 pass
(which met the requirements).
Level 2: at 120 mmHg
Level 3: at 160 mmHg | Level 1: pass at 80 mmHg
Level 2: pass at 120 mmHg
Level 3: pass at 160 mmHg | Similar | |
| Biocompatibility | | | | |
| Cytotoxicity | Under the conditions of the
study, show potential cytotoxicity. | Under the conditions of the study,
not cytotoxic. | Different | |
| Irritation | Under the conditions of the
study, not an irritant. | Under the conditions of the study,
not an irritant. | Same | |
| Sensitization | Under conditions of the study,
not a sensitizer. | Under conditions of the study, not
a sensitizer. | Same | |
| Acute systemic
toxicity | Under the conditions of the
study, no systemic toxicity from
the device. | -- | Similar | |
| Test item | Test purpose | Acceptance criteria | Results | |
| Performance
test | Flammability | Testing the characteristics of a
material that pertain to its relat
ive ease of ignition and relative
ability to sustain combustion. | Class 1
ASTM F2100 | Pass |
| | Bacterial Filtration
Efficiency | Testing the effectiveness of
medical face mask material in
preventing the passage of
aerosolized bacteria. | Level 2: ≥ 98%
ASTM F2100 | Pass |
| | Different Pressure,
mm H2O/cm² | Measuring the pressure of
dropping across a medical face
mask material. | Level 2: