FLUID RESISTANT MASK

K955556 · American Threshold Healthcare · FXX · Apr 25, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955556
• Device Name: FLUID RESISTANT MASK
• Applicant: American Threshold Healthcare
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

Device Story

Fluid resistant mask designed for infection control; minimizes exhaled microorganism contamination; reduces wearer exposure to blood/body fluids. Construction: three-layer composite; outer/inner facings of spunbonded polyolefin or cellulosic material; meltblown polyolefin filter media. Edges sonically welded; includes malleable aluminum nose wire for fit; attachment via ties or elastic earloops. Used in clinical/surgical settings by healthcare providers. Device acts as physical barrier; filtration efficiency >95% for 1.0 and 0.1 micron particles; breathability (pressure drop) ≤5.0 mm water. Provides protection against fluid penetration and particulate matter.

Clinical Evidence

Bench testing only. No clinical data. Testing included: Water Resistance (Impact Penetration Test, Nelson Labs SOP#MBG/037), Differential Pressure (Delta P Test, Nelson Labs SOP#ARO/006), and Latex Particle Challenge (Nelson Labs SOP#ARO/011). Results: Differential pressure averaged 2.19-2.54 mm water. Filtration efficiency for polyolefin inner facing: 99.3% (1.0 micron), 98.4% (0.1 micron). Filtration efficiency for cellulosic inner facing: 99.2% (1.0 micron), 99.2% (0.1 micron).

Technological Characteristics

Three-layer construction: spunbonded polyolefin or cellulosic outer/inner facings; meltblown polyolefin filter media. Malleable aluminum nose wire. Sonic welding for edge sealing and attachment of ties/earloops. Breathability: ≤5.0 mm water pressure drop. Filtration: >95% efficiency at 1.0 and 0.1 microns.

Indications for Use

Indicated for use by healthcare personnel to minimize contamination from exhaled microorganisms and reduce exposure to blood and body fluids during surgical or clinical procedures.

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

• Tecnol Fluid Resistant Surgical Mask (K874608)
• 3M Fluid Resistant Mask (K910110)

Reference Devices

• American Threshold Surgical Mask (K801036)

Submission Summary (Full Text)

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K955556
K955556

510 (k) SUMMARY

APR 25 1996

Submitted by: American Threshold Industries
240 Sardis Road
Enka, N.C. 28828

Contact Person: Frances Mayhew, Quality Assurance Manager

Date of Submission: Original - December 4, 1995

Device Name: Fluid Resistant Mask
Classification Name: MASK, SURGICAL

Predicate Device(s):
1. Tecnol Fluid Resistant Surgical Mask, 510 (k) #K874608, dated December 2, 1987.
2. 3M Fluid Resistant Mask, 510 (k) #K910110, dated March 20, 1991

Device Description:

The Fluid Resistant Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earlopos sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose.

All of the materials used in the construction of the masks are being used in other currently marketed devices, such as our regular surgical mask, 510 (k) #K801036.

These masks filter particles at an average efficiency of greater than 95% when tested at both 1.0 micron and 0.1 micron particle sizes. The breathability of the masks (measured by the pressure drop across the mask) averages no more than 5.0 mm of water.

All of the materials used in the construction of the mask are used in other currently marketed devices, these include:

- American Threshold Surgical Mask 510(k) #K801036
- Tecnol Surgical Mask 510(k) #K874608
- 3M Surgical Mask 510(k) #K910110

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# Statement of Intended Use:

This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

## Testing Submitted to Determine Substantial Equivalence and Device Claims:

1. Water Resistance, Impact Penetration Test, Nelson Laboratories SOP#MBG/037
- This procedure is designed to measure the resistance of materials to water penetration under contact with sprayed water. This test was performed to demonstrate substantial equivalence.

2. Differential Pressure, Delta P Test, Nelson Laboratories SOP#ARO/006
- The differential pressure test determines the air exchange differential of porous materials and is important for determining the breathability of surgical face masks. This test was performed to demonstrate substantial equivalence.

3. Latex Particle Challenge, Nelson Laboratories SOP#ARO/011
- This procedure provides for evaluation of non-viable particle retention or filtration efficiency of barrier materials. This test was performed to substantiate device claims.

## Conclusions Drawn from the Results of the Above Testing:

1. Water Resistance, Impact Penetration Test Results:

**American Threshold Fluid Resistant Mask:**
- Average per-cent increase in blotter weight = 2.64% increase in the first study and 9.15% in the second.

**Tecnol Fluid Resistant Mask:**
- Average per-cent increase in blotter weight = 49.33% increase in the first study and 2.99% in the second.

2. Differential Pressure, Delta P Test Results:

**American Threshold Fluid Resistant Mask:**
- Differential Pressure average was 2.19 in the first study and 2.54 in the second.

**Tecnol Fluid Resistant Mask:**
- Differential Pressure average was 1.99 in the first study and 2.68 in the second.

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3. Latex Particle Challenge Test Results:

American Threshold Fluid Resistant Mask:

-Average filtration efficiency for Polyolefin Inner Facing:

1.0 micron particle size = 99.3% filtration efficiency
0.1 micron particle size = 98.4% filtration efficiency

-Average filtration efficiency for Cellulosic Inner Facing:

1.0 micron particle size = 99.2% filtration efficiency
0.1 micron particle size = 99.2% filtration efficiency

Based on the above test results American Threshold Industries considers their fluid resistant mask to be substantially equivalent to the other fluid resistant masks currently on the market.