CONVERTORS IMPERVIOUS SHOE COVERS

K970815 · Allegiance Healthcare Corp. · FXP · Mar 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970815
• Device Name: CONVERTORS IMPERVIOUS SHOE COVERS
• Applicant: Allegiance Healthcare Corp.
• Product Code: FXP · General, Plastic Surgery
• Decision Date: Mar 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 1

Intended Use

The Convertors® Impervious Shoe Covers are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material

Device Story

Convertors® Impervious Shoe Covers; worn by operating room personnel during surgery; barrier protection against microorganisms, body fluids, and particulates; composed of nonwoven fabric laminated to synthetic polymer film; protects both patient and staff; single-use protective apparel.

Clinical Evidence

Bench testing only. Evaluated via physical qualification tests: flammability, hydrostatic head, synthetic blood penetration, Phi X174 penetration, alcohol repellency, trapezoid tear, grab tensile, Mullen burst, Elmendorf tear, basis weight, thickness, coefficient of friction, electrostatic decay, and abrasion. All requirements met.

Technological Characteristics

Materials: 1.5 osy blue spunbonded polypropylene nonwoven fabric hot melt adhesively laminated to 1.25 mil embossed polyethylene film. Barrier protection principle.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate material.

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

• Kimberly-Clark X-Tra Traction Impervious Boot

Submission Summary (Full Text)

{0}

MAR 27 1997
K970815
p1/2

**Allegiance**

*Allegiance Healthcare Corporation*
*1500 Waukegan Road*
*McGaw Park, Illinois 60085-6787*
*847.473.1500*
*FAX: [phone]*

## XII. *SMDA REQUIREMENTS*

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
*Convertors® Impervious Shoe Covers*

**Manufacturer:** Allegiance Healthcare Corporation
*Convertors® Operations*
One Butterfield Trail
El Paso, Texas 79906

**Regulatory Affairs Contact:** Sharon Robbins
*Allegiance Healthcare Corporation*
1500 Waukegan Road MPK
McGaw Park, IL 60085

**Telephone:** [phone]

**Date Summary Prepared:** March, 1997

**Common Name:** Convertors® Impervious Shoe Covers

**Classification:** Class I per 21CFR § 878.4040

**Predicate Device:** Kimberly-Clark X-Tra Traction Impervious Boot

**Description:** These shoe covers will be composed of a nonwoven fabric hot melt adhesively laminated to a synthetic polymer film. The nonwoven is a 1.5 osy blue spunbonded polypropylene. The film is a 1.25 mil embossed, polyethylene.

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{1}

K970815
p 2/2

# Allegiance

*Allegiance Healthcare Corporation*
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: [phone]

## XII. **SMDA REQUIREMENTS** (continued)

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
**Convertors® Impervious Shoe Covers**

**Intended Use:**

The Convertors® Impervious Shoe Covers are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material

**Substantial Equivalence:**

The Convertors® Shoe cover material is substantially equivalent to the Kimberly-Clark X-Tra Traction Impervious Boots in that:

- the intended use is the same
- the performance attributes are similar

**Summary of testing:**

All materials used in the fabrication of this Convertors® shoe cover materials were evaluated through physical qualification tests. The tests performed on the Shoe Covers were Flammability, Hydrostatic head, Synthetic Blood Penetration, Phi X174 Penetration, Alcohol Repellency, Trapezoid Tear, Grab Tensile, Mullen Burst, Elmendorf Tear, Basis Weight, Thickness, Coefficient of Friction, Electrostatic Decay and Abrasion. These shoe covers have met the requirements of the applicable standards and were found to be acceptable for the intended use.

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