SURGICAL MASKS

• K Number: K111559
• Device Name: SURGICAL MASKS
• Manufacturer: SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD.
• Date Cleared: 2011-09-16 ( 102 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.

Device Description

The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid. The proposed devices are available in four models with same mask (3-ply) and different configurations, such as ear loop, tie on, eye shield and foam. Detail configurations of them are presented in Table V-1 Surgical Masks Description. All of the proposed devices are non-sterile, and only for single use.

Predicate Devices

K061864

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of surgical masks, with no mention of AI or ML.

Therapeutic

No.

The device is a surgical mask indicated for protection against microorganisms and body fluids, not for treating or rehabilitating a medical condition.

Diagnostic

No
The device is a surgical mask, which is a protective barrier, not a diagnostic tool used to identify medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical surgical mask made of 3-ply material with different configurations (ear loop, tie on, etc.). The performance studies are bench tests on the physical properties of the mask materials. There is no mention of software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the masks are for "protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures." This is a physical barrier function, not a diagnostic one.
• Device Description: The description reinforces the physical barrier function and mentions different configurations for wearing the mask. There is no mention of analyzing samples from the body or providing diagnostic information.
• Performance Studies: The performance studies focus on the physical properties of the mask, such as filtration efficiency, fluid resistance, flammability, and biocompatibility. These are relevant to the mask's function as a barrier, not as a diagnostic tool.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro examination of specimens.

In summary, the device is a physical barrier intended for protection during medical procedures, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.

The proposed devices are available in four models with same mask (3-ply) and different configurations, such as ear loop, tie on, eye shield and foam. Detail configurations of them are presented in Table V-1 Surgical Masks Description.
All of the proposed devices are non-sterile, and only for single use.

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 workers and patients involved in medical and surgical procedures.

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)

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies: with the following standards:

• ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face a. Masks.
• ف Fluid Resistance per ASTM F 1862-07 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• Bacterial Filtration Efficiency (BFE) Test per EN 14683: 2005 Surgical masks, Requirements and ن test methods.
• Particulate Filtration Efficiency (Latex Particle Challenge) Test per ASTM F 2299-03 Standard Test di Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
• Flammability , per 16 CFR 1610, Standard for the Flammability of Clothing Textiles; Corrections e.
• Differential Pressure (Delta-P) Test per Mil M36954C Military Specification- Mask, Surgical, f. Disposable
• Biocompatibility :Cytotoxicity, Sensitization, Irritation g.
  • Including: ISO 10993-5:2009 "Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
    • ISO 10993-10:2002 Standard, "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity"
    • ISO 10993-10:2002 Standard and Amendment 1, 2006. "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT I"

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K061864

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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SEP 1 6 2011

AI I for K111559 Surgical Masks

Exhibit #1 510(k) Summary

Exhibit # 1 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

• 1. Date of Submission: May 20, 2011
• 2. Sponsor

Shanghai Neo-Medical Import & Export Co.,Ltd Room 1503, No.2368, ZhongShanxi Road, Shanghai, 200030, China Establishment Registration Number: 3005327291 Contact Person: Pei Zhang Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]

• 4. Proposed Device Identification Proposed Device Name: Surgical Masks Proposed Model: NM-MA-008, NM-MA-010, NM-MA-011 and NM-MA-018 Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General & Plastic Surgery .
     Intended Use Statement:

1

The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.

• 5. Predicate Device Identification 510(k) Number: K061864 Product Name: Non Sterile Surgical Mask Manufacturer: Dukal Corporation
• 6. Device Description

The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.

The proposed devices are available in four models with same mask (3-ply) and different configurations, such as ear loop, tie on, eye shield and foam. Detail configurations of them are presented in Table V-1 Surgical Masks Description.

| Product

Model:	Model Description
	Mask	Ear loop	Tie on	Shield
NM-MA-010	X	X
NM-MA-011	X		X
NM-MA-008	X		X	X
NM-MA-018	X	X		X

Table III-1 Surgical Masks Description

All of the proposed devices are non-sterile, and only for single use.

• 7. Non-Clinical Test Conclusion
     Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies: with the following standards:

• ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face a. Masks.

• ف Fluid Resistance per ASTM F 1862-07 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

2

2

• Bacterial Filtration Efficiency (BFE) Test per EN 14683: 2005 Surgical masks, Requirements and ن test methods.
• Particulate Filtration Efficiency (Latex Particle Challenge) Test per ASTM F 2299-03 Standard Test di Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
• Flammability , per 16 CFR 1610, Standard for the Flammability of Clothing Textiles; Corrections e.
• Differential Pressure (Delta-P) Test per Mil M36954C Military Specification- Mask, Surgical, f. Disposable
• Biocompatibility :Cytotoxicity, Sensitization, Irritation g.
  • Including: ISO 10993-5:2009 "Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
    • ISO 10993-10:2002 Standard, "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity"
    • ISO 10993-10:2002 Standard and Amendment 1, 2006. "Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT I"
• 8. Substantially Equivalent Conclusion

The proposed devices are determined to be Substantially Equivalent (SE) to the predicate device, Non Sterile Surgical Mask (K061864) in respect of safety and effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 1 6 2011

Shanghai Neo Medical Import & Export Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237

Re: K111559

Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 9, 2011 Received: August 26, 2011

Dear Ms. 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. 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.

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Page 2 - Ms. Hong

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn fo

Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit #3 IFU Statement

510(k) Number: K111559 Device Name: Surgical Masks Models: NM-MA-008, NM-MA-010, NM-MA-011, NM-MA-018

Indications for Use:

The Surgical Masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid.

□PRESCRIPTION USE (Part 21 CFR 801 Subpart D) ZOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Elliott F. Currie W.K.

(ISON 2008) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111559