ValuMax" Surgical Masks is 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 materials.

Device Description

ValuMax" Surgical Masks are pleated 3-ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. The nose piece for all ValuMax® Face Masks is malleable aluminum wire. Fog free masks have an anti-fog strip. Masks with splash visors have anti-fog treated plastic shield attached to masks. All of the material used in the construction of the ValuMax® Surgical Masks are being used in currently marketed devices (see predicate information).

AI/ML Overview

The provided document describes the acceptance criteria and performance of ValuMax Surgical Masks. However, it does not include a study that proves the device meets the acceptance criteria in the way a typical AI healthcare device study would. Instead, it outlines non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test. Instead, it concludes that "Performance Testing met all relevant requirements of the aforementioned test standards." The performance categories tested are:

Acceptance Criteria Category	Reported Device Performance / Evaluation
Bacterial Filtration Efficiency (BFE)	Met all relevant requirements of test standards.
Pressure Differential (Delta P)	Met all relevant requirements of test standards.
Latex Particle Challenge (PFE)	Met all relevant requirements of test standards.
Flammability	Met all relevant requirements of test standards.
Biocompatibility (per ISO 10933)	Met all relevant requirements of test standards.
Fluid Resistant Synthetic Blood Penetration Resistant Test	Met all relevant requirements of test standards.

Study Details (Based on the provided text)

Since this is for a physical medical device (surgical masks) and not an AI/software device, many of the requested categories (like sample size for test set, experts for ground truth, MRMC study, training set) are not applicable or not provided in the typical sense for an AI study. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."

Here's what can be extracted:

Sample size used for the test set and the data provenance: Not specified in the provided text, as the "tests" refer to non-clinical performance evaluations of the masks themselves, not a diagnostic algorithm. The provenance would be the manufacturing facility, Qing Dao Tong Hui Clothing Co., Ltd. in China, where the masks are produced and tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of tests (filtration efficiency, breathability, flammability, etc.) is established through standardized laboratory procedures and measurements, not expert consensus on medical images or diagnoses.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance tests are objective measurements based on established standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical surgical mask, not an AI diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is based on the objective physical properties and performance characteristics of the mask as measured by standardized laboratory test methods (e.g., bacterial filtration rate, pressure differential, particle filtration, flammability).
The sample size for the training set: Not applicable. There is no AI model or algorithm being trained for this device.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (surgical masks). It establishes substantial equivalence to a predicate device based on non-clinical performance testing against established standards, rather than a clinical trial or AI model validation study. Therefore, many of the requested details specific to AI device studies are not present or not relevant.

Summary

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ValuMax International Inc.

848 Hausman Road. Allentown PA 18104 Tel: 86-532-7937188 Fax: 86-532-7937288

C. 510(K) SUMMARY- Revised 5-6-04

This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

The assigned 510K number is K040333

1. Submitter & Foreign Manufacturer Identification

Qing Dao Tong Hui Clothing Co., Ltd. Xue-Chi Road, Hong Dao Industrial Park, Cheng Yang District, Qing Dao, Shan Dong, China 266114 Tel: 86-532-7937188 Fax: 86-532-7937288 Submitter's FDA Registration Number: 9616875

2. US Agent & Applicant

ValuMax International Inc. 848 Hausman Road Allentown PA 18104 Fax: 610-336-0102 Tel: 610-336-0101

3. Contact Person

Ms. Janet Jia. President ValuMax International Inc. 848 Hausman Road Allentown PA 18104 Tel: 610-336-0101 Fax: 610-336-0102

Date of Summary: January 21, 2004

4. Name of the Device:

ValuMax " Surgical Ear Loop Masks Blue, Pink, Green, Yellow, White, Peach ●
ValuMax" Surgical Fog Free Ear-Loop Masks- Blue, Pink, Green, White, Peach .
ValuMax Surgical Tie-On Masks Blue, Pink, Green, Yellow, White, Peach ●
ValuMax Surgical Fog Free Tie-On Masks Blue, Pink, Green, Yellow, White .
ValuMax" Surgical Ear-Loop Masks with splash visor Blue, Pink, Peach ●
ValuMax" Surgical Tie-On Masks with splash visor Blue, White, Peach ●

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ValuMax International Inc.

848 Hausman Road, Allentown PA 18104 Tel: 86-532-7937188 Fax: 86-532-7937288

C. 510(K) SUMMARY - Continued

5. Classification Name: Mask, Surgical

6. Predicate Device Information: K012602 - Crosstex Surgical Masks

7. Device Description:

8. Intended Use - Revised on 5-27-2004:

The following ValuMax" Surgical Masks are intended for use 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 materials.

ValuMax" Surgical Ear Loop Masks Blue, Pink, Green, Yellow, White, Peach .
ValuMax Surgical Fog Free Ear-Loop Masks- Blue, Pink, Green, White, Peach .
ValuMax" Surgical Tie-On Masks Blue, Pink, Green, Yellow, White, Peach .
ValuMax" Surgical Fog Free Tie-On Masks Blue, Pink, Green, Yellow, White .
ValuMax" Surgical Ear-Loop Masks with splash visor Blue, Pink, Peach .
ValuMax" Surgical Tie-On Masks with splash visor Blue, White, Peach .

9. Comparison to Predicate Devices:

See previous attached documents

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ValuMax International Inc.

848 Hausman Road, Allentown PA 18104 Tel: 86-532-7937188 Fax: 86-532-7937288

C. 510(K) SUMMARY - Continued

10. Discussion of Non-Clinical Tests Performed for Dertermination of Substantial Equivalent are as Follows:

Bacterial Filtration Efficiency (BFE) a.
Pressure Differential (Delta P) b.
c. Latex Particle Challenge (PFE)
d. Flammability
Biocompatibility per ISO 10933 e.
Fluid Resistant Synthetic Blood Penetration Resistant Test f.

It is our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards.

11. Discussion of Clinical Tests Performed:

Not Applicable

12. Conclusions:

The ValuMax" Surgical Masks have the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness. The ValuMax® Surgical Masks are substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Ms. Janet Jia President ValuMax International, Incorporated 848 Hausman Road Allentown, Pennsylvania 18104

Re: K040333

Trade/Device Name: Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or without Visors, Ties and Earloops. Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: May 27, 2004 Received: June 1, 2004

Dear Ms. Jia:

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 approvisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), it may of bacyoo in the Code of Federal Regulations, Title 21, Parts 800 to 898. In Jour act FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jia

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and registments, including, but not limited to: registration You must comply with an the rice b required (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 807), abouting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality bjocks. (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) IThis letter will anow you to ough mading of substantial equivalence of your device to a premarket notification. - The PDF innulis in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at 7.0 Tompliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may oveant other generalational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chris Liu, Ph.D.

Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number: K040333

Device Name:

ValuMax® Surgical Ear Loop Masks -- Blue, Pink, Green, Yellow, White, Peach ValuMax® Surgical Fog Free Ear-Loop Masks- Blue, Pink, Green, White, Peach ValuMax® Surgical Tie-On Masks - Blue, Pink, Green, Yellow, White, Peach ValuMax Surgical Fog Free Tie-On Masks - Blue, Pink, Green, Yellow, White ValuMax® Surgical Ear-Loop Masks with splash visors - Blue, Pink, Peach ValuMax® Surgical Tie-On Masks with splash visors - Blue, White, Peach

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kain Mulvey

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K040333

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.