TRIMAX

K012268 · Standard Textile Co., Inc. · FYA · Dec 3, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012268
• Device Name: TRIMAX
• Applicant: Standard Textile Co., Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Device Story

TriMax Surgical Gown is a reusable surgical apparel item made of 100% polyester. Device is distributed non-sterile; intended for sterilization by healthcare facilities or laundry services via prevacuum steam cycles. Gown is designed for use by operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate matter. Device maintains performance through 75 wash, dry, and sterilization cycles. Healthcare providers wear the gown to protect both patient and staff from cross-contamination. Clinical benefit is the reduction of infection risk during surgery through established barrier protection.

Clinical Evidence

Bench testing only. Testing included: Flammability (16 CFR Part 1610), Viral Resistance (ASTM #1671-97b), Suter Hydrostatic Testing (AATCC #127-1989), Mullens Hydrostatic Testing (ASTM D751-95), Strength (ASTM #D-1682-87), Lint (EDANA 220.0-96), Cytotoxicity (MEM Elution), Acute Systemic Toxicity (ISO 10993), Primary Skin Irritation (ISO 10993), and Colorfastness (AATCC #61-1993). Durability verified through 75 wash, dry, and sterilization cycles.

Technological Characteristics

Material: 100% polyester. Form factor: Surgical gown. Sterilization: Non-sterile, compatible with prevacuum steam cycles. Performance standards: ASTM #1671-97b (viral resistance), AATCC #127-1989 (hydrostatic), ASTM D751-95 (hydrostatic), ASTM #D-1682-87 (strength), EDANA 220.0-96 (lint), AATCC #61-1993 (colorfastness).

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patients and personnel from transfer of 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

• ComPel XTR® Surgical Gowns (K922753)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a black and white emblem. The emblem is in the shape of a shield with a thick border. Inside the shield are the letters 'S' and 'T' intertwined.

Page 93

HEALTHCARE TEXTILE COMPANY

DEC 0 3 2001

vorld headquarter NE KNOLLCREST D O BOX 371805 CINCINNATI, OHIO 5222-1805 13-761-9255 3-761-0467 FA

012268

## 510(k) Summary

This summary of 510(k) safety and effectiveness is being supplied in accordance with the Safe Medical Device Act of 1990 and 21 C.F.R.

807.92(a)

| 1. | Standard Textile Co., Inc.<br>One Knollcrest Drive<br>Cincinnati, Ohio 45237 | Contact Person: Brad Bushman<br>[phone] Ext. 455<br>Summary Prepared on 6/29/01 | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------|--------------------|---------------|----------------------|---------------------------------------|
| 2. | <table><tr><td>Device Name:</td><td>TriMax Surgical Gown, non-sterile (75X reusable)</td></tr><tr><td>Common/Usual Name:</td><td>Surgical Gown</td></tr><tr><td>Classification Name:</td><td>Surgical Apparel 21 C.F.R. § 878.4040</td></tr></table> | Device Name: | TriMax Surgical Gown, non-sterile (75X reusable) | Common/Usual Name: | Surgical Gown | Classification Name: | Surgical Apparel 21 C.F.R. § 878.4040 |
| Device Name: | TriMax Surgical Gown, non-sterile (75X reusable) | | | | | | |
| Common/Usual Name: | Surgical Gown | | | | | | |
| Classification Name: | Surgical Apparel 21 C.F.R. § 878.4040 | | | | | | |
| 3. | Predicate Device: | ComPel XTR® Surgical Gowns #K922753 | | | | | |

- All fabric components used in TriMax Surgical Gowns are made from 100% polyester. 4.
TriMax Surgical Gown will function as surgical gowns when processed according to instructions These products will be manufactured and through 75 complete wash, dry and sterilization cycles. distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies

- TriMax Surgical Gown are intended to be worn by operating room personnel during surgical procedures ર. to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
There are no critical differences in the use of this product from currently marketed ComPel XTR® Surgical Gowns except for higher liquid resistance claims, additional viral resistance claims and sleeve seam performance claims. TriMax Surgical Gown have demonstrated that they will perform as intended when used as labeled.

- The tests that have been successfully completed include: 6.
- Flammability 16 CFR Part 1610. a.
- Barrier Performance b.
- Viral Resistance ASTM #1671-97b i.
- Suter Hydrostatic Testing AATCC #127-1989 ii.
- Mullens Hydrostatic Testing ASTM D751-95 Procedure A iii.
- Strength ASTM #D-1682-87 C.
- Lint EDANA 220.0-96 d.
- Toxicity Cytotoxicity MEM Elution (MG023) e. Acute Systemic Toxicity (ISO 10993)
- Primary Skin Irritation (ISO 10993)) f.
- Sterilization Product sold non-sterile; can be sterilized using prevacuum steam cycles. g.
- Durability through 75 processing (wash, dry and sterilization). h.
- Colorfastness to Commercial Laundering AATCC #61-1993(4A). i.

To the best of my knowledge, all data and information in the 510(k) are truthful and accurate, and that no material fact has been omitted.

Bradley J. Bushman

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and resemble a human figure in motion or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bradley J. Bushman Director, Technical Resources Standard Textile Company, Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45237-1600

Re: K012268

Trade/Device Name: Trimax Regulation Number: 878.4040 Regulation Name: Surgical Gown Regulatory Class: II Product Code: FYA Dated: October 15, 2001 Received: October 19, 2001

Dear Mr. Bushman:

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.

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

DEC 0 3 2001

{2}------------------------------------------------

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rict of any I outh all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (2) roquicellents as lectronic 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 This letter with and w you're cognification. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

To be issued KO12268 510(k) NUMBER:

TriMax Surgical Gown DEVICE NAME:

## INDICATIONS FOR USE:

TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Chis tom

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1)