The Wellmien Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

Device Description

WELLMIEN's surgical masks (for single use only) are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire. All of the materials used in the construction of the WELLMIEN's surgical masks are being used in currently marketed devices.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Wellmien Surgical Mask (K101000)

This document describes the acceptance criteria and the study performed to demonstrate that the Wellmien Surgical Mask meets these criteria, as presented in the 510(k) submission K101000.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance of the predicate device (K060776) and relevant consensus standards. The study aimed to demonstrate substantial equivalence by showing comparable performance.

Test	Acceptance Criteria (Predicate Device K060776)	Reported Device Performance (Wellmien Surgical Mask)	Status
Fluid Resistance Performance	Fluid Resistance	Fluid Resistance	Met
Particle Filtration Efficiency (PFE)	96.8%	99.8%	Met
Bacteria Filtration Efficiency (BFE)	At least 99.9%	99.9%	Met
Differential Pressure (Delta P)	Average 2.34 (mm Water/cm²)	3.7-4.0 (mm Water/cm²)	Met
Flammability	Class 1 None Flammable	Class 1 None Flammable	Met
Biocompatibility	Biocompatible	Biocompatible	Met

Note on Acceptance Criteria: For some tests like Fluid Resistance and Biocompatibility, the acceptance criterion is a qualitative assessment (e.g., "Fluid Resistance" or "Biocompatible") rather than a specific numerical threshold explicitly stated as separate acceptance criteria for the predicate device within this document. The study demonstrates that the Wellmien device also meets this qualitative assessment. For Delta-P, the Wellmien device's measured range falls within a generally acceptable range for surgical masks and is considered comparable to the predicate device, even if the average numerical value is different.

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

The document does not explicitly state the sample size used for each specific test (e.g., number of masks tested for BFE, PFE, etc.). However, it indicates that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These standards would inherently specify sample sizes for each test.

The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer's testing facilities or contract labs. The study is a retrospective evaluation based on laboratory bench testing of the finished device.

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

This information is not applicable as the evaluation involved objective laboratory performance tests against established standards, not interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective clinical or imaging studies involving human readers. This information is not applicable as the study involved objective laboratory performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a physical device like a surgical mask.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study is typically associated with AI/software algorithms. This information is not applicable as the device is a physical surgical mask, and its performance is evaluated through material and filtration characteristics, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests was established by objective laboratory measurements against the specified consensus standards (e.g., ASTM F2101-07 for BFE, ASTM F2299-03 for PFE, 16 CFR 1610 for flammability, ISO 10993 for biocompatibility, ASTM F1682-07 for fluid resistance). The performance of the predicate device also serves as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. The Wellmien Surgical Mask is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for a physical device.

Summary

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K101000

Section 5: 510(k) Summary:

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

1. Contact Information

AUG - 5 ZUIU

Submitter & Foreign Manufacturer Identification Wellmien (Suzhou) Imp. & Exp. Trading Co., Ltd 1-711, No.636 Ganjiang East Road Suzhou, Jiangsu Province, China, Zip code: 215005 Tel: 86-512-81881706

Submitter's FDA Registration Number : N/A

US Agent and Contact Person Chengyu Shen Manton Business and Technology Services 5 Carey Street, Pennington, NJ 08534 Tel: 608-217-9358, Email: cyshen@aol.com

Date of Summary: March 23, 2010 Date of Revision 1: June 5, 2010

2. Regulatory Information

Name of Device: Surgical Mask (For Single Use Only) Panel: General Hospital Class: Class 2 Regulation Number: 21 CFR 807.4040 Product Code: FXX Classification Name: Mask, Surgical

Predicate Device Information: 3.

K060776: Surgical Face Mask (Yellow, White, Green, Pink) by Hong Ya Non-Woven Products Co., Ltd

4. Device description:

WELLMIEN's surgical masks (for single use only) are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media。 Ear-loops are made of soft elastic loops. The nose piece for all WELLMIEN's face masks is malleable aluminum wire. All of the materials used in the construction of the WELLMIEN's surgical masks are being used in currently marketed devices. (see Predicate Device information )

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5. Intended Use:

6. Comparison to Predicate Devices

WELLMIEN Surgical Mask (for single use only) is compared with it Predicate Device: K060776: Surgical Face Mask (Yellow, White, Green, Pink) by Hong Ya Non-Woven Products Co., Ltd. The design, material, and performance of both devices are very similar, and the two products are substantially equivalent in safety and effectiveness.

Description	Our Device	Predicate Device (K060776)
Indication forUse	Nose and mouth covering for healthcare workers and patients to preventmicroorganism, body fluid, andparticulate aerosol transfer.	Same
Layers	Three	Three
Materials	Outer layer is made of 100% spun-bond polypropylene.	Outer layer is made of 100% spun-bond polypropylene.
	Middle player is made of 100% meltblown polypropylene filter media.	Middle player is made of 100% meltblown polypropylene filter media.
	Inner layer is made of 100% spun-bond polypropylene.	Inner layer is made of 100% spun-bond-polypropylene.
	Ear-loops are made of soft elastic loops.The nose piece is malleable aluminum wire	Ear-loops are made of soft elastic loops.The nose piece is malleable aluminum wire
Dimensions	Large: 18x9cm, Medium:17.5x9.5cm, Small: 14.5x9 cm	N/A
Mask style	Flat Pleated	Flat Pleated
Design	Ear Loop	Ear Loop
Color	Blue	Yellow, White, Green, Pink
NIOSHcertification	N/A	N/A

Comparison of Intended Use, Design, Material, and Specifications

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Comparison of Device Performance
Test	Our Device	Predicate Device (K060776)
Fluid ResistancePerformance	Fluid Resistance	Fluid Resistance
Particle FiltrationEfficiency	99.8%	96.8%
Bacteria FiltrationEfficiency	99.9%	At least 99.9%
DifferentialPressure (Delta-P)	3.7-4.0 (mm Water/cm²)	Average 2.34 (mm Water/cm²)
Flammability	Class 1 None Flammable	Class 1 None Flammable
Biocompatibility	Biocompatible	Biocompatible

7. Discussion of Non-Clinical Tests Performed to Determine Substantial Equivalence

The following non-clinical tests were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the respective consensus standards. Test results met all relevant requirements in the test standards, and are comparable to the predicate device.

Bacterial Filtration Efficiency (BFE) : ASTM F2101-07 (1)
Pressure Differential (Delta P) (2)
(3) Latex Particle Challenge(PFE): ASTM F2299-03
Flammability: 16 CFR 1610 (4)
Biocompatibility per ISO 10933 (ર)
Fluid Resistant Synthetic Blood Penetration Resistant Test: ASTM (6) F1682-07

More detailed comparison of the design, technical, and performance characteristics to the predicate device are summarized in Section 7: Summary Report. More details of non-clinical tests are summarized in Section 7.5 and 7.6.

8. Discussion of Clinical Tests Performed Not applicable

9. Conclusions

The WELLMIEN's surgical masks (for single use only) have the same intended use and technological characteristics as the predicate devices.

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Moreover, bench testing contained in this submission demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness。 WELLMIEN's surgical masks (for single use only) are substantially equivalent to the predicate device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Wellmien (Suzhou) Import and Export Company, Limited C/O Mr. Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, New Jersey 08534

Re: K101000

Trade/Device Name: Wellmien Surgical Mask (for single use only) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: June 2, 2010 Received: June 25, 2010

Dear Mr. Shen:

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.

AUG - 9 2010

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Page 2- Mr. Shen

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.

Susan Ruines

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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01000

Indications for Use

510(k) Number (if known): K101000

AUG - 9 2010

Device Name: Wellmien Surgical Mask (for single use only)

Indications for Use:

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)

Eliz. H. F. Llanetto Wills

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

01 000 510(k) Number:

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.