← Product Code [FXX](/productcode/FXX) · K023755

# WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD (K023755)

_Winner Industries (Shenzhen) Co., Ltd. · FXX · Jun 10, 2003 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K023755

## Device Facts

- **Applicant:** Winner Industries (Shenzhen) Co., Ltd.
- **Product Code:** [FXX](/productcode/FXX.md)
- **Decision Date:** Jun 10, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Indications for Use

Medical facemask / shield are intended to be used 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 matter.

## Device Story

Winner Medical facemasks are pleated 3-ply surgical masks, available with or without an integrated plastic shield with non-fog coating. The device consists of an inner and outer layer sandwiching a polypropylene filter material. Used in operating room settings by surgical personnel, the mask acts as a physical barrier to reduce the transfer of microorganisms, body fluids, and particulate matter between the patient and the healthcare provider. The device is a passive protective barrier; it does not involve electronic processing, software, or active sensing.

## Clinical Evidence

Bench testing only. Testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, and ISO skin irritation and sensitization.

## Technological Characteristics

Pleated 3-ply construction; inner and outer layers with middle polypropylene filter material; optional plastic shield with non-fog coating. Passive barrier device. No energy source, software, or connectivity.

## Regulatory 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.

## Special Controls

*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.

## Predicate Devices

- Crosstex Earloop & Tie Face Masks with/without splash visor ([K012602](/device/K012602.md))
- White Knight Shield Mask ([K001892](/device/K001892.md))

## Submission Summary (Full Text)

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## JUN 1 0 2003

Winner

17415-1 Sia Pirk Circle it > me. > : http:// 92614

රික්‍රමය විකාශ ප්‍රධාන පිහිටා පිහිටි පිහිටි පිහිටි විසින් පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි ප

## mer Modical | SA. Inc.

Tel: 949-161-5339 Firm 9 Fr - 35 L9007

## 510K SUMMARY

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: K023755

- 1. Submitter's Identification:
Winner Industries Co., LTD Winner Industrial Park,Bulong RD., Longhua, Shenzhen Shenzhen China 518109 Telephone: 86-755-28138888 Facsimile: 86-755-28134588

U.S. Agent: Winner Medical USA, Inc. 17815 Sky Park Circle, Suite A Irvine, California 92614 Telephone: 800-996--9222 Facsimile: 949-261-9007

Contact Person: Ming Xie, Vice President

Date of Summary: 11-3-02

- 2. Device Name:
Winner Ear Loop Procedure Mask, Blue, Pink, White & Green Winner Tie-On Surgical Mask, Blue, Pink, White & Green Winner Ear Loop Procedure Mask with Shield, Blue, Pink, White & Green Winner Tie-On Surgical Mask with Shield, Blue, Pink, White & Green

- 3. Classification Name: Mask, Surgical
- 4. Predicate Device:
	- a. K012602 Crosstex Earloop & Tie Face Masks with/without splash visor.
	- b. K001892 White Knight Shield Mask

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- 5. Intended Use: Medical facemask / shield are intended to be used 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 matter.
- 6. Device Description/ Comparison:

These masks are pleated 3-ply masks with an inner and outer layer that sandwich a polypropylene filter material. On some masks a plastic shield with a non-fog coating is incorporated. The masks are identical to the predicate devices in design, materials used and performance in non-clinical testing. This testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, ISO skin irritation and sensitization. This information has been included with this submission.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2003

Winner Industries (Shenzhen) Company Limited C/O Mr. Ming Xie Winner Medical USA, Incorporated 17815 Sky Park Circle, Suite A Irvine, California 92614

Re: K023755

Trade/Device Name: Winner Ear Loop Procedure Mask, Tie-On Surgical Mask & Ear-Loop White, Green, Blue, Pink with and without Face Shield Regulation Number: 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: FXX Dated: May 13, 2003 Received: May 14, 2003

Dear Mr. Xie:

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.

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 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. Xie

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of Compliance 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 Division of Small Manufacturers, International 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,

Susa Purser

Susan Runner, DDS, MA Interim 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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510k Number (if Known): K023755

Device Name: Winner Medical Facemasks (various colors, with and without shields)

## Indications for Use:

Winner Medical facemask / shield are intended to be used 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 matter.

Concurrence of CFRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR Over-the-Counter Use:

Olin S. Lir

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

510(k) Number: K023755

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**Source:** [https://fda-staging.innolitics.com/device/K023755](https://fda-staging.innolitics.com/device/K023755)

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