Disposable Surgical Mask

• K Number: K202341
• Device Name: Disposable Surgical Mask
• Manufacturer: Shanghai Jianzhong Medical Packaging Co., Ltd.
• Date Cleared: 2021-02-12 ( 179 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

The Disposable Surgical 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 and sterile.

Device Description

The proposed device, Disposable Surgical Mask is a three-layer, flat-folded mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The color of the surgical mask is blue. The disposable surgical mask is available in three different specifications: 17.5*9.5cm, 14.5*9.5cm and 14.5*8cm. The device is single use and provided non-sterile and sterile.

Predicate Devices

K160269

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 a surgical mask, with no mention of AI or ML.

Therapeutic

No
The device is a surgical mask intended for infection control to protect from transfer of microorganisms, body fluids, and particulate material, not for treating a disease or condition.

Diagnostic

No

The device description and intended use clearly state that it is a surgical mask designed to protect against microorganisms and fluids, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, three-layer mask with ear straps and a nose clip, and the performance studies focus on physical properties like fluid resistance, filtration, and flammability. There is no mention of software components.

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 protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
• Device Description: The description details the physical construction of a mask, not a device used to examine specimens from the human body.
• Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
• Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility), not on diagnostic accuracy.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable Surgical 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 and sterile.

Models: 17.59.5cm-3ply (sterile), 14.59.5cm-3ply (sterile), 14.58cm-3ply (sterile)
17.59.5cm-3ply (non-sterile), 14.59.5cm-3ply (non-sterile), 14.58cm-3ply (non-sterile)

Product codes

FXX

Device Description

The proposed device, Disposable Surgical Mask is a three-layer, flat-folded mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The color of the surgical mask is blue. The disposable surgical mask is available in three different specifications: 17.59.5cm, 14.59.5cm and 14.5*8cm. The device is single use and provided non-sterile and 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

Non clinical 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:

• ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
• ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
• 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 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 F2101-2017 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• BS EN 14683 Medical face masks - Requirements and test methods, Annex C: Method for determination of breathability (differential pressure)

No clinical study is included in this submission.

Key Metrics

Fluid Resistance: Pass at 160 mmHg
Particulate efficiency level: Pass at >98.01%
Bacterial filtration level: Pass at >98.12%
Differential pressure: Pass at

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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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2021

Shanghai Jianzhong Medical Packaging Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K202341

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 13, 2021 Received: January 14, 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.

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For CAPT Elizabeth Claverie-Williams, MS 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202341

Device Name Disposable Surgical Mask

Indications for Use (Describe)

The Disposable Surgical 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 nonsterile and sterile.

Models: 17.59.5cm-3ply (sterile), 14.59.5cm-3ply (sterile), 14.58cm-3ply (sterile) 17.59.5cm-3ply (non-sterile), 14.59.5cm-3ply (non-sterile), 14.58cm-3ply (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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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: K202341

• Date of Preparation: 02/12/2021 1.
• 2. Sponsor Identification

Shanghai Jianzhong Medical Packaging Co., Ltd. Bldg 16, 789# Puxing Road, Minhang District, Shanghai 201114, P.R. China

Establishment Registration Number: 3005030944.

Contact Person: Nina Huang Position: Marketing Manager Tel: [phone]-5201 Fax: [phone] Email: [e-mail]

• 3. Designated Submission Correspondent
     Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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4. Identification of Proposed Device

Trade Name: Disposable Surgical Mask

Common Name: Surgical mask

Models: 17.59.5cm-3ply (sterile), 14.59.5cm-3ply (sterile), 14.5*8cm-3ply (sterile)

17.59.5cm-3ply (non-sterile), 14.59.5cm-3ply (non-sterile), 14.5*8cm-3ply (non-sterile)

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 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 and sterile.

Models: 17.59.5cm-3ply (sterile), 14.59.5cm-3ply (sterile), 14.58cm-3ply (sterile) 17.59.5cm-3ply (non-sterile), 14.59.5cm-3ply (non-sterile), 14.58cm-3ply (non-sterile)

Device Description:

The proposed device, Disposable Surgical Mask is a three-layer, flat-folded mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The color of the surgical mask is blue. The disposable surgical mask is available in three different specifications: 17.59.5cm, 14.59.5cm and 14.5*8cm. The device is single use and provided non-sterile and sterile.

• న. Identification of Predicate Device
  510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on) Models: EL 10000, EL 10010, TO 10000, TO 10010 EL 20000, EL 20010, TO 20000, TO 20010 EL 30000, EL 30010, TO 30000, TO 30010

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6. Comparison of Technological Characteristics
ITEM	Proposed Device
K202341	Predicate Device
K160269	Comparison
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 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 and sterile.
Models: 17.5*9.5cm-3ply (sterile),
14.5*9.5cm-3ply (sterile),
14.5*8cm-3ply (sterile),
17.5*9.5cm-3ply (non-sterile),
14.5*9.5cm-3ply (non-sterile),
14.5*8cm-3ply (non-sterile)	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.
Models: EL 10000, EL 10010, TO 10000, TO 10010, EL 20000, EL 20010, TO 20000, TO 20010, EL 30000, EL 30010, TO 30000, TO 30010	Similar
Configuration	ear strap
nose clip
mask body	ear strap/ Tie-on
nose clip
mask body	Similar
Dimension	17.5*9.5 cm
14.5*9.5 cm
14.5*8 cm	17.5*9 cm
18*9 cm	Different
Level	Level III	Level III	Same
Fluid
Resistance	Pass at 160 mmHg	Pass at 160 mmHg	Same
Particulate
efficiency
level	Pass at >98.01%	Passed at 99.7%	Similar
Bacterial
filtration level	Pass at >98.12%	Passed at >99%	Similar
Differential
pressure	Pass at ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals

• 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 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)

• A 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
• A ASTM F2101-2017 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
• A BS EN 14683 Medical face masks - Requirements and test methods, Annex C: Method for

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determination of breathability (differential pressure)

• 8. Clinical Test Conclusion
     No clinical study is included in this submission.
• 9. Conclusion
     Based on the technological comparison and nonclinical tests described above, the subject devices, Disposable Surgical Masks, are as safe, as effective, and perform as well or better than the legally marketed predicate device cleared under K160269.