This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Device Description

Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Epard Protective Products Surgical Face Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Test Method	Predicate Results (K022256)	Acceptance Criteria (New Device)	New Device Performance	Passes/Fails
Fluid Resistance (mmHg)	ASTM F 1862	No visual detection of penetration	Passed	No visual detection of penetration	Passes
Particulate Filtration Efficiency (%) (0.1um)	ASTM F2299	2.0 microns	98.7%	N/A (implied >= 98.7%)	Passes
Bacterial Filtration Efficiency (%)	ASTM F2101-01	97.9%	99.9%	N/A (implied >= 99.9%)	Passes
Differential Pressure (Delta-P) (mm H2O/cm2)	Mil- M369454C	1.8	2.0 - 2.5	N/A (implied 2.0-2.5)	Passes
Flammability Class	16 CFR 1610	2	Classified as Class I	N/A (implied Class I)	Passes

Notes on the Table:

"N/A (implied)": The document states "Equivalence is demonstrated through intended use, materials, design and testing methods" and "no significant differences between the application device and the predicate." For performance characteristics where the predicate result is given as the "Acceptance Criteria or Results" for the new device, this implies the new device met or exceeded these values. The document doesn't explicitly list the new device's numerical performance for each criterion but rather indicates it passed against the established criteria, which are the predicate's results for some metrics.
"Passed": For Fluid Resistance, the predicate's result was "No visual detection of penetration," and this was also the acceptance criteria for the new device, which it passed.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size used for the test set for any of the performance characteristics.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are standard ASTM and military specifications, implying laboratory testing. The submission is from Epard Protective Products, Ltd. in Hubei, China, so the testing was likely conducted by or contracted by this manufacturer, possibly in China or a certified testing facility elsewhere. The nature of the performance tests suggests individual product testing, rather than human data that would be classified as retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given the nature of the device (surgical face mask) and the performance criteria (fluid resistance, filtration efficiency, differential pressure, flammability), the "ground truth" is established through objective laboratory testing according to standardized protocols (ASTM, Mil-Spec, CFR).

Therefore, no human experts were used to establish ground truth in the way one might for diagnostic imaging interpretation. The "ground truth" is the result derived from the physical testing methods themselves.

4. Adjudication Method for the Test Set

As the "ground truth" is established through objective, standardized physical testing rather than human interpretation, no adjudication method (like 2+1 or 3+1 consensus) was applicable or used. The test results are quantitative or qualitative (e.g., "no visual detection") outcomes of the laboratory procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned or conducted. This type of study is typically relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved in assessing cases. Surgical face masks are passive protective equipment, and their performance is evaluated through material science and physical property testing, not through human reader interpretation of cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to a surgical face mask. Standalone performance studies refer to the performance of an algorithm or AI without human involvement, common in AI-powered diagnostic tools. A surgical face mask is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and observations derived from standardized laboratory performance tests. These are:

Quantitative measurements: Percentage for filtration efficiency, mm H2O/cm2 for differential pressure.
Qualitative observation: "No visual penetration" for fluid resistance.
Classification: "Flammability Class."

This is akin to laboratory/physical property ground truth.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set." The testing described evaluates the manufactured product's inherent physical properties against established standards.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for a surgical face mask.

Summary

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K093901/5004

Section 5: 510(k) Summary

SEP 1 0 2010

1. Original Preparation Date: December 17, 2009

Submitted by:

ﺎﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

Epard Protective Products, Ltd. No. 1 Bailongguan Quijialing District Jinshan Hubei, China 431821

Contact Person/Prepared by:

Darren Reeves Phone: (804) 307-7706 Fax: (866) 393-4954 Email: dpdist@bww.com

3. Device Identification:

Trade Name: Surgical Face Mask Common Name: Mask, Surgical Classification: Surgical Apparel (21 CFR 878.4040, Product Code FXX)

Tucker & Associates, Surgical Face Mask (K022256) Predicate Device: 4.

5. Device Description:

Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue

6. Intended Use:

This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

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K093901/S004

7. Comparison to Predicate:

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Device and Predicate Device Descriptions

Description	Your Device	Predicate = K022256
Materials	Same	Outer Coverstock: Spunbond polypropyleneInner Coverstock: Spunbond polypropyleneFilter: Melt Blown PolypropyleneNose band: AluminumTape: PolypropyleneTie: Polypropylene3-ply, White, Blue, Green, Yellow and Pink
Specifications and dimensions	Same	7 X 3.75 pleated mask with 15-16 inch ties and 5 inch aluminum nose band
Mask style	Same	Pleat tucks at 1.5, 2.1 and 2.7 inches
Design features	Same	Tie-On or ear loops
NIOSH certification number (when available)	N/A	N/A
Performance Characteristics	Test Method	Predicate Results (K022256)	Acceptance Criteria or Results
Fluid Resistance Performance (mmHg)	ASTM F 1862 - 80 mmHg	No visual detection of penetration.	Passed
Particulate Filtration Efficiency Performance (%)	ASTM F2299 - 0.1um	2.0 microns	98.7%
Bacterial Filtration Efficiency Performance (%)	ASTM F2101-01	97.9%	99.9%
Differential Pressure (Delta-P) (mm H2O/cm2)	Mil- M369454C	1.8	2.0 - 2.5
Flammability class Class 1	16 CFR 1610	2	Classified as Class I

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K093901/5004

8. Conclusion:

The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and testing methods.

Similarities/Differences of the proposed device when compared to the predicate: 9.

The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a sans-serif font and is black. To the left of the text is a symbol that appears to be a stylized representation of a person.

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

Epard Protective Products, Limited C/O Mr. Darren Reeves DP Distribution & Consulting, LLC 15637 Fox Cove Circle Moseley, Virginia 23120

SEP 1 0 2010

Re: K093901

Trade/Device Name: Surgical Face Mask ear loop yellow Surgical Face Mask ear loop blue Surgical Face Mask tie-on vellow Surgical Face Mask tie-on blue

Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 31, 2010 Received: September 2, 2010

Dear Mr. Reeves:

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 Aci 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 Eederal Register.

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Page 2- Mr. Reeves-

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. 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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K 093901/5004

Indications for Use

510(k) Number (if known):

Device Name:

Surgical Face Mask ear loop yellow .
Surgical Face Mask ear loop blue .
Surgical Face Mask tie-on yellow .
Surgical Face Mask tie-on blue .

Surgical Face Mask

Indications for Use:

This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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) ोक्ति

(Disister Billing Diffit) (Division of Anastlessiskogy General Hospitalal Division Controlo Dental Devicesses

1093901

510(k) Number.:

SEP 1 0 2010

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.