DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE

K033057 · Deroyal · FYA · Nov 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033057
• Device Name: DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
• Applicant: Deroyal
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The DeRoyal Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect both the operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate material.

Device Story

DeRoyal Surgical Gowns are disposable protective apparel for operating room personnel. Constructed from Polypropylene Spunbond Meltblown Spunbond (SMS) material; designed to act as a physical barrier to prevent cross-contamination of microorganisms, body fluids, and particulates between patients and staff during surgery. Available in sterile and non-sterile configurations; supplied in bulk, single units, or as components within surgical kits. Used in clinical surgical environments; worn by surgeons, nurses, and OR staff. Provides protection through material barrier properties; no active electronic or mechanical components.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through standardized testing for fluid resistance, barrier protection, and material strength.

Technological Characteristics

Material: Polypropylene Spunbond Meltblown Spunbond (SMS). Standards: ISO 10993, AATCC 127, AATCC 42, ASTM 1671, 16 CFR 1610, ASTM 1342, ASTM D1424, ASTM D5034, NFPA. Form factor: Disposable surgical gown. Sterilization: Sterile and non-sterile options available.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to provide a barrier against the transfer of microorganisms, body fluids, and particulate matter between the patient and the personnel.

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

• PrimeLine primaGARD Surgical Gowns (K023117)
• Precept Ultraguard™ Surgical Gowns

Submission Summary (Full Text)

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DeRoyal Industries, Inc.

K033057

## DeRoyal Surgical Gowns

### 510(k) Summary

#### Summary of the Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Based

#### SUBMITTER INFORMATION:

| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | [phone] |
|----------|--------------------------|----------------------|--------------------|
| ADDRESS: | 200 DeBusk Lane | CONTACT: | Sharon Cook |
| | Powell, TN 37849 | DATE OF PREPARATION: | September 25, 2003 |

#### DEVICE NAMES

| Name: | Surgical Gowns |
|----------------------|-------------------------------|
| COMMON/USUAL NAME: | Surgical Gowns |
| CLASSIFICATION NAME: | FYA, Surgical Apparel |
| | Class II device, per 878.4040 |

# PREDICATE OR LEGALLY MARKETED DEVICES

PrimeLine primaGARD Surgical Gowns (K023117) Precept Ultraguard™ Surgical Gowns (no 510k available, Owner/Operator number 9038820)

### DEVICE DESCRIPTION

The DeRoyal Surgical Gowns are comprised of Polypropylene Spunbond Meltblown Spunbond (SMS) material commonly used in the industry for these devices have been tested according to relevant performance standards (ISO 10993, AATCC 127, AATCC42, ASTM1671, 16 CFR 1610, ASTM 1342, ASTM D1424, ASTM D5034, NFPA Standards) to determine their equivalency to the predicate devices.

### DEVICE INTENDED USE

The DeRoyal Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect both the operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate material.

#### TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICES

| Characteristic | DeRoyal Device | Other Devices |
|----------------|------------------------------------------------------------|------------------------------------------------------------|
| Material | Spunbond Meltblown Spunbond<br>(SMS) | Spunbond Meltblown Spunbond<br>(SMS) |
| Color | Blue | Blue |
| Sizes | Various | Various |
| Sterility | Sterile and Non-Sterile | Sterile and Non-Sterile |
| Disposable | Yes | Yes |
| Package | Bulk, single put-ups or as a<br>component in trays or kits | Bulk, single put ups or as a<br>component in trays or kits |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Ms. Sharon Cook Regulatory Affairs Group Manager DeRoyal Industries, Incorporated 200 DeBusk Lane Powell, Tennessee 37849

Re: K033057

Trade/Device Name: DeRoyal Surgical Gowns, Sterile, Non-Sterile Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 25, 2003 Received: September 29, 2003

Dear Ms. Cook:

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 mav, 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.

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# Page 2 - Ms. Cook

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), v 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/dsma/dsmamain.html

Sincerely yours,

Sirser Q.unas

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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## Indications for Use Statement

510(k): K033057 Device Name: DeRoyal Surgical Gowns Starte, non-sterele

Intended Use: DeRoyal Surgical Gowns are identified in 21 CFR, part 878.4040 as surgical attire to be worn by operating room personnel during surgical procedures to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials.

Susanna F. Pasulu

sthesiology, General Hospital, I. Dental Devices

510(k) Number: K033057

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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