The Surgical Face Mask, Type: Tie-on, Ear-loop is 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 situation where there is a risk of microorganism and body fluid.

Device Description

Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 10000 melt-blown polypropylene (MBPP). The inner layer is made of either 10000 medical grade tissue paper or 10000 SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices. The Surgical Face Mask, Type: Tie-on, Ear-loop is 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 situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

AI/ML Overview

This document is a 510(k) premarket notification for a Surgical Face Mask. The information provided describes the acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of a novel AI-powered medical device. Therefore, many of the requested categories are not applicable to this submission.

Here's an analysis based on the provided text, addressing the relevant points:

1. A table of acceptance criteria and the reported device performance

Test/Characteristic	Acceptance Criteria (Predicate Device K051291)	Reported Device Performance (Angeline Group Ltd. Surgical Face Mask)
Bacterial Filtration Efficiency	98%	99%
Fluid Resistance	Passed at 80 mmHg (ASTM F1862-05)	Passed at 120 mmHg (EN 14683: 2005)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for individual tests. The document refers to "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests."
Data Provenance: The tests were conducted internally or by a contracted lab to Angeline Group Ltd., whose address is in Taipei, Taiwan. The specific testing standards (EN 14683:2005, ASTM F1862-05, ISQ10993-5: 2009) are international. The data is prospective as it was generated for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This submission is for a physical medical device (surgical face mask) and relies on objective, standardized laboratory tests, not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As per point 3, there's no expert adjudication involved for physical and mechanical tests.

5. 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 is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluation of the surgical mask is the established pass/fail criteria defined by recognized international standards for medical device testing (e.g., EN 14683 for masks, ASTM for fluid resistance, ISO for biocompatibility). These standards specify methodologies and acceptance thresholds.

8. The sample size for the training set

Not Applicable. This is not an AI-powered device, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable. As per point 8.

Summary

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K110027

AUG - 5 2011

Angeline Group Ltd. 510(k) Notification

Type of Submission:

5.1

Surgical Face Mask Type: Tie-on, Ear-loop

510(k) Summary

Traditional

5.2 Submitter:	Angeline Group Ltd.
Address:	No.9-2f, Lane 206, Jhonggang Road, Hsinjuang City, Taipei, Taiwan, 242
Phone:	+886-2-8993-5668
Fax:	+886-2-2992-7367
Contact:	Charles Sun
Establishment Registration Number:	N/A

5.3 Identification of the Device:

Proprietary/Trade name:	Surgical Face Mask, Type: Tie-on, Ear-loop
Common Name:	Surgical Face Mask, Disposable
Classification Name:	Mask, Surgical
Device Classification:	II
Regulation Number:	878.4040
Panel:	General & Plastic Surgery
Product Code:	FXX

5.4 Identification of the Predicate Device:

Predicate Device Name:	Non-Sterile Surgical Mask
Manufacturer:	A.R. Medicom Inc.
510(k) Number or Clearance Information:	K051291

5.5 Intended Use and Indications for Use of the subject device.

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K110027

Surgical Face Mask Type: Tie-on, Ear-loop

5.6 Device Description

5.7 Non-clinical Testing

A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Angeline Group Ltd. Surgical Face Mask. The physical and mechanical tests were conducted in accordance with EN 14683:2005 Surgical masks, Requirements and test methods, and the biocompatibility tests were conducted in accordance with ISQ10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. All the test results demonstrate the performance of Angeline Group Ltd. Surgical Face Mask meets the requirements of its pre-defined acceptance criteria and intended uses.

The results of the non-clinical testing demonstrate that the Angeline Group Ltd. Surgical Face Mask is as safe and effective as the predicate devices.

5.8 Safety and Effectiveness

The result of bench testing indicates that the new device is as safe and effective as the predicate device.

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K110027

Surgical Face Mask Type: Tie-on, Ear-loop

5.9 Substantial Equivalence Determination

The Angeline Group Ltd. Surgical Face Mask submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared A.R. Medicom Inc. Non-Sterile Surgical Mask which is the subject of K051291. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item	Predicate Device(K051291, A.R. Medicom Inc. Non-SterileSurgical Mask)	Proposed Device(Angeline Group Ltd.Surgical Face Mask, Type:Tie-on, Ear-loop)
Similarity
Intended Use	Intended as a protective nose and mouthcovering for health care workers andpatients involved in medical and surgicalprocedures. The masks are indicated in anyprocedure or situation where there is a riskof microorganism, body fluid, andparticulate aerosol transfer.	Same
Materials	Out layer: SBPPFilter: MBPPInner Layer: SBPPEar Loop: ElasticNosepiece: Aluminum	SameSameSameSameSame
Sample types	Tie-on, Ear-loop	Same
Design	Fluid resistantFlat, pleated	SameSame
Sterile	No	Same
Single Use	Yes	Same
Difference
Bacterial FiltrationEfficiency	98%	99%

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Surgical Face Mask Type: Tie-on, Ear-loop

Performance (%)
Fluid Resistance	ASTM F1862-05,	EN 14683: 2005,
Performance (mmHg)	Passed at 80 mmHg	Passed at 120 mmHg

5.10Conclusion

Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop has the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission supplied demonstrates that the different technological characteristics do not raise any new questions of safety or effectiveness. In conclusion, Angeline Group Ltd. Surgical Face Mask, Type: Tie-on, Ear-loop maintains the same safety and effectiveness as the substantially equivalent predicate devices, Non-Sterile Surgical Mask.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the figure. The text is in all caps and appears to be in a sans-serif font.

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

Angeline Group Limited C/O Mr. Michael Lee President ACME Biotechs Company, Limited No.45, Minsheng Road Danshui Town Taipei County China (Taiwan) 251

AUG - 5 2011

Re: K110027

Trade/Device Name: Surgical Face Mask, Type: Tie-on, Ear-Ioop Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: July 20, 2011 Received: July 20, 2011

Dear Mr. Lee:

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.

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Page 2 - Mr. Lee

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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Surgical Face Mask Type: Tie-on, Ear-loop

Indications for Use

510(k) Number (if known):

K110027

Device Name: Surgical Face Mask, Type: Tie-on, Ear-loop

Colors: White/Light Blue/Light Green/Light Yellow

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number. K110027

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.