PRESTIGE AMERITECH FACE MASK

K061716 · Prestige Ameritech · FXX · Aug 14, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061716
• Device Name: PRESTIGE AMERITECH FACE MASK
• Applicant: Prestige Ameritech
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Aug 14, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Device Story

Prestige Ameritech Surgical Masks are three-layer, flat-folded, pleated disposable face masks. Construction includes an inner layer of cellulose or spunbonded polypropylene, a middle meltblown polypropylene filter, and an outer layer of medical-grade tissue or spunbonded polypropylene. Variants include optional anti-fog plastic splash shields. Masks are secured via tie strips or latex-free elastic earloops and feature a malleable aluminum nosepiece for fit. Used in operating rooms, dental, and isolation settings to protect wearers and patients from cross-contamination of fluids and particulates. Bench testing confirms performance against fluid resistance, filtration efficiency, and flammability standards.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F1862 (Fluid Resistance), ASTM F2299 (Particulate Filtration Efficiency: 98.5% at 0.1 microns), ASTM F2101 (Bacterial Filtration Efficiency: 99.6%), MIL M36954C (Differential Pressure: 2.6), and 16CFR 1610 (Flammability Class 1). Biocompatibility testing performed per ISO 10993-10.

Technological Characteristics

Three-layer construction: cellulose/spunbonded polypropylene inner, meltblown polypropylene filter, medical-grade tissue/spunbonded polypropylene outer. Features: malleable aluminum nosepiece, tie strips or latex-free elastic earloops, optional anti-fog plastic splash shield. Standards: ASTM F1862, ASTM F2299, ASTM F2101, MIL M36954C, 16CFR 1610, ISO 10993-10.

Indications for Use

Indicated for use by healthcare personnel and patients in operating rooms, dental, isolation, and medical settings to provide a barrier against microorganisms, body fluids, and particulates. Single-use disposable.

Regulatory Classification

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

• Tucker and Associates Surgical Face Mask (K022256)
• Hong Ya Non-Woven Products Co. Ltd. Surgical Face Mask (K060776)

Submission Summary (Full Text)

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## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990.

The assigned 510(k) number is: K061716

- Submitted for: Prestige Ameritech 7425 Airport Frwy. Fort Worth, TX. 76118 817 595-1131 Establishment Registration number: 3005022483 Dan Reese, President Contact Person: 7425 Airport Frwy. Fort Worth, TX. 76118 817 595-1131 Date Prepared: July 19, 2006 Proprietary Name: Prestige Ameritech Face Mask (multiple labels); Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach Common Name: Surgical Face Mask Classification Name: Mask, Surgical Classification Product Code: FXX Regulation Number: 878.4040 Predicate Devices: Tucker and Associates Surgical Face Mask K022256 Hong Ya Non-Woven Products Co. Ltd. Surgical Face Mask K060776

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## KOG1716

Device Description: The Prestige Ameritech Surgical Mask device is composed of three layers of material flat folded and pleated to form the Mask. The inner layer is composed of cellulose or spunbonded polypropylene, the middle layer is a meltblown polypropylene filter material and the outer layer is a medical grade tissue or spunbonded polypropylene. Masks with splash shields have anti-fog plastic shields attached to masks. Masks are held in place on wearer with tie strips or latex free elastic loops and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Surgical Face Masks and are being used in current legally marketed devices.

Intended Use: The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue. Green, White, Peach

| Performance<br>Characteristics | Test Method | Results<br>K022256 | Results<br>K060776 | Results<br>Prestige<br>Ameritech<br>Device |
|--------------------------------------|----------------|--------------------------|-------------------------|--------------------------------------------|
| Fluid Resistance | ASTM<br>F1862 | No Visual<br>Penetration | Fluid<br>Resistant | Fluid<br>Resistant |
| Particulate Filtration<br>Efficiency | ASTM<br>F2299 | 2.0<br>microns | 96.8% at 0.1<br>microns | 98.5% at 0.1<br>Microns |
| Bacterial Filtration<br>Efficiency | ASTM<br>F2101 | 97.9% | 99.9% | 99.6% |
| Differential Pressure | Mil<br>M36954C | 1.8 | 2.34 | 2.6 |
| Flammability Class | 16CFR 1610 | 2 | 1 | 1 |

### Comparison To Predicate Devices:

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Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence:

- 1) Fluid Resistance-ASTM F1862
- 2) Particulate Filtration Efficiency-ASTM F2299
- 3) Bacterial Filtration Efficiency-ASTM F2101
- 4) Differential Pressure-MIL M36954C
- 5) Flammability Testing-16CFR 1610
- 6) Irritation and Sensitization-ISO 10993-10

Conclusions: The Prestige Ameritech Face Masks have the same intended use and technological characteristics as the predicate devices K022256 and K060776. Moreover, bench testing contained in this submission demonstrates that the technological characteristics do not raise any new question of safety or effectiveness. Therefore, the Prestige Face Mask (multiple labels) is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2006

Mr. Dan Reese President Prestige Ameritech 7425 Airport Freeway Fort Worth, Texas 76118

Rc: K061716

Trade/Device Name: Prestige Ameritech Face Mask (Multiple Labels) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: July 17, 2006 Received: July 20, 2006

Dear Mr. Reese:

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 Lederal Register.

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#### Page 2 - Mr. Reesc

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte Y. Michael Dms.

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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# K061716

### Indications for Use

510(k) Number (if known):

**Device Name:**

Device Name;

Indications For Use:

The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White. Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach

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

Over-The-Counter Use (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)

Shale H. Munday, R.D. 8/9/04
(Sign-Off)

ion of Anesthesiology, General Hospital,
ion Control, Dental Devices

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