CONVERTORS POLYOLEFIN FABRIC GOWNS

K961341 · Baxter Healthcare Corp · FYA · Oct 28, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961341
• Device Name: CONVERTORS POLYOLEFIN FABRIC GOWNS
• Applicant: Baxter Healthcare Corp
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical apparel 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® SMS Polyolefin Gowns; protective surgical apparel. Construction: single layer SMS polyolefin fabric; fabric-reinforced versions include additional SMS layer in sleeves/body; poly-reinforced versions include additional polyolefin film in sleeves/body. Used in operating room by surgical personnel. Function: physical barrier to prevent transfer of microorganisms, body fluids, and particulates between patient and staff. Packaged with standard towel. Benefit: reduced risk of cross-contamination during surgery.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, and irritation/intracutaneous reactivity. Materials met all requirements.

Technological Characteristics

Materials: SMS (spunbond-meltblown-spunbond) polyolefin fabric; polyolefin film. Construction: single layer or reinforced (fabric or film) in sleeve/body areas. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide barrier protection 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

• Convertors® SMS Polyethylene standard gown (K961341)
• Kimberly-Clark Standard, Fabric and Poly-reinforced Gowns (K961341)

Submission Summary (Full Text)

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OCT 28 1996
K961341
Surgical Group
Baxter Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085 USA
847.473.1500
FAX: [phone]

# Baxter

## XII. SMDA REQUIREMENTS

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Convertors® SMS Polyolefin Gowns

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

**Regulatory Affairs Contact:**
Sharon Richter
Surgical Group
1500 Waukegan Road MPK
McGaw Park, IL 60085

**Telephone:** [phone]

**Date Summary Prepared:** March, 1996

**Common Name:** Convertors® SMS Polyolefin Gowns

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

**Predicate Device:** Convertors® SMS Polyolefin Standard Gown and the Kimberly-Clark Standard, Fabric and Poly-reinforced Gowns

**Description:**
The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

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# XII. SMDA REQUIREMENTS (continued)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Convertors® SMS Polyolefin Gowns

### Intended Use:
Surgical apparel 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® SMS Polyolefin gown is substantially equivalent to the Convertors® SMS Polyethylene standard gown and Kimberly-Clark standard, fabric- and poly-reinforced gowns in that:
- the intended use is the same
- the performance attributes are the same

### Summary of testing:
All materials used in the fabrication of this Convertors® SMS Polyolefin gown were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.

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# XIII. SAMPLE

A prototype of a standard SMS gown has been provided (enclosed) to visually assist with the review. (See Appendix D).

# XIV. KIT INFORMATION

Each gown is packaged with a towel. The towel is the same towel that is currently placed in our gown packs. This towel has been used safely and effectively for many years as a component of the gown pack. This premarket notification (510(k)) is to introduce standard, fabric and poly-reinforced gowns constructed of SMS fabric. There is no change to the towel contained within this pack.

# XV. 21 CFR 807.95 -CONFIDENTIALITY

The Surgical Group of Baxter Healthcare Corporation regards its intent to market the Convertors® SMS Polyolefin gown as confidential commercial information. Baxter has not divulged this intent to market information to anyone other than Baxter employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.