Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a disposable surgical face mask, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No
The device is described as a Disposable Surgical Face Mask intended for protection against microorganisms and fluids, which falls under infection control rather than therapy.

Diagnostic

No
Explanation: The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It is not designed to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of materials like polypropylene, PE, iron, Nylon, and spandex, and the performance studies focus on physical properties and biological interactions, not software functionality.

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 mask is for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn over the mouth and nose. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components designed to analyze biological samples.
Performance Studies: The performance studies focus on the physical properties of the mask, such as filtration efficiency, fluid resistance, breathability, flammability, and biocompatibility (skin irritation and sensitization). These are tests related to the mask's ability to act as a barrier and be safely worn, not tests related to diagnosing a condition or analyzing a biological sample.
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 is a physical barrier intended for infection control, 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 Disposable Surgical Face Mask 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 a single use, disposable device(s), provided non-sterile.

Product codes

FXX

Device Description

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On (model: JB-DM04) or Ear Loops (model: JB-DM03) way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The model JB-DM04 of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

The model JB-DM03 of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex.

The nose chip contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and iron.

The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

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

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device meets the acceptance criteria with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5. 2004:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
EN 14683, Medical Face Masks-Requirements and Test Methods;
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
A ASTM F2299, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
16 CFR 1610, Standard for the Flammability of clothing textiles;

Key Metrics

Fluid Resistance Performance ASTM F1862:

Proposed Device 1 (model: JB-DM04): 32 out of 32 pass at 160 mmHg
Proposed Device 2 (model: JB-DM03): 32 out of 32 pass at 120 mmHg
Acceptance Criteria (level 2&3): 29 out of 32 pass at 160 mmHg for level 3, 29 out of 32 pass at 120 mmHg for level 2

Particulate Filtration Efficiency ASTM F2299:

Proposed Device 1 (model: JB-DM04): 99.9%
Proposed Device 2 (model: JB-DM03): 99.9%
Acceptance Criteria (level 2&3): ≥ 98%

Bacterial Filtration Efficiency ASTM F2101:

Proposed Device 1 (model: JB-DM04): >99.9%
Proposed Device 2 (model: JB-DM03): >99.9%
Acceptance Criteria (level 2&3): ≥ 98%

Differential Pressure (Delta P) EN 14683 Annex C:

Proposed Device 1 (model: JB-DM04): 2.21mmH2O/cm²
Proposed Device 2 (model: JB-DM03): 2.53mmH2O/cm²
Acceptance Criteria (level 2&3):

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

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a sans-serif font.

April 6, 2021

Anhui Jiabao Protective Equipments Co., Ltd % Mandy Wu Consultant Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K203801

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: December 28, 2020 Received: December 28, 2020

Dear Mandy Wu:

We have reviewed vour 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/cdrl/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.

Clarence W. Murray III -S

For Ryan Ortega, PhD Acting 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

Indications for Use

510(k) Number (if known) K203801

Device Name Disposable Surgical Face Mask

Indications for Use (Describe)

The Disposable Surgical Face Mask 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 a single use, disposable device(s), provided non-sterile.

Type of Use (Select one or both, as applicable)	X
-------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------

| | 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary

for K203801

4

312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China,

237000

510(K) Summary

K203801

Summary prepared date:2021-03-05

A. Applicant:

Name: Anhui Jiabao Protective Equipments Co., Ltd Address: 312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China, 237000 Contact Person: Mark Zhang Tel: +86 564-3963993, +86 180 7272 9283 Fax: +86 564-3963997 Mail: mark.zhang@jjabaofs.com

Submission Correspondent: Primary contact: Ms. Mandy Wu Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: min.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com

B. Device:

Trade Name: Disposable Surgical Face Mask Common Name: Surgical Face Mask Model(s):JB-DM03 (Ear Loops), JB-DM04 (Tie on)

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K153496 Disposable Surgical Face Mask K200923 Single-use Surgical Mask

5

312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China,

237000

D. Indications for use of the device:

The Disposable Surgical Face Mask is intended to be worn to protect 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 a single use, disposable device(s), provided non-sterile.

E. Device Description:

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On (model: JB-DM04) or Ear Loops (model: JB-DM03) way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The model JB-DM04 of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.

The model JB-DM03 of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex.

The nose chip contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and iron.

The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

F. Technological Characteristics Comparison with predicate device

Device	Proposed Device	Predicate Device	Comparison
Manufacturer	Anhui Jiabao Protective
Equipments Co., Ltd	BYD Precision
Manufacturer Co. Ltd	-
510K number	K203801	K200923	-
Classification	Class II Device, FXX (21
CFR878.4040)	Class II Device, FXX (21
CFR878.4040)	Same
Indications for use	The Disposable Surgical
Face Mask 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 a single use,	The Single-use Surgical
Masks (Model: FE2311)
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.	Similar

Table 1 General Comparison

6

312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu' an City, Anhui Province, China,

| | | disposable device(s),
provided non-sterile. | This is a single use,
disposable device(s),
provided non-sterile. | Comparison |
|------------------------------------|-----------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------|
| Ear loop model
and tie-on model | | JB-DM03(Ear Loops, Flat
Pleated, 3 layers)
JB-DM04(Tie-On, Flat
Pleated, 3 layers), | Ear Loops, Flat Pleated, 3
layers | Analysis |
| Mate
rial | Outer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle
layer | Melt blown
polypropylene filter | Melt blown polypropylene
filter | Same |
| | Inner | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose clip | | PE and iron | Malleable aluminum wire | Analysis |
| Tie-one | | Spun-bond polypropylene | / | Analysis |
| Ear loops | | Nylon and spandex | Polyester | Analysis |
| Color | | Blue | Blue | Same |
| Dimension | | 17.5 cm +/- 0.5 cm | 17.5 cm +/- 0.4 cm | Analysis |
| Dimension | | 9.5 cm +/- 0.5 cm | 9.5 cm +/- 0.4 cm | Analysis |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Use | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 level | | Level 2 and 3 | Level 3 | Analysis |
| Biocompatibility | | ISO10993 | ISO10993 | Same |

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device meets the acceptance criteria with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5. 2004:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
EN 14683, Medical Face Masks-Requirements and Test Methods;
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of > Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;

7

312 State Road Intersection With Dongwu Road, Economic Development Zone, Lu'an City, Anhui Province, China,

237000

A ASTM F2299, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
16 CFR 1610, Standard for the Flammability of clothing textiles;

Test Methodology	Proposed device1 (model: JB-DM04)	Proposed device2 (model: JB-DM03)	Acceptance Criteria (level 2&3)	Result
Fluid Resistance
Performance ASTM F1862	32 out of 32 pass at 160 mmHg	32 out of 32 pass at 120 mmHg	29 out of 32 pass at 160 mmHg for level 3
29 out of 32 pass at 120 mmHg for level 2	PASS
Particulate
Filtration
Efficiency
ASTM F2299	99.9%	99.9%	≥ 98%	PASS
Bacterial
Filtration
Efficiency
ASTM F2101	>99.9%	>99.9%	≥ 98%	PASS
Differential Pressure
(Delta P) EN 14683
Annex C	2.21mmH2O/cm²	2.53mmH2O/cm²