BARRIER SURGICAL DRAPES

K051625 · Molnlycke Health Care, Inc. · KKX · Jul 14, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051625
• Device Name: BARRIER SURGICAL DRAPES
• Applicant: Molnlycke Health Care, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.

Device Story

BARRIER® Surgical Drapes are single-use protective coverings designed to isolate surgical incision sites from microbial contamination and bloodborne pathogens. The device consists of various fabrics, films, and materials configured into patient drapes, equipment drapes, and drape components. Used in clinical settings across a wide range of surgical specialties—including cardiovascular, orthopaedic, and pediatric surgery—the drapes provide a physical barrier to prevent exposure to infectious materials. Healthcare providers apply the drapes to the patient or equipment to maintain a sterile field. The drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material construction, providing varying levels of liquid barrier performance to enhance patient and staff safety during procedures.

Clinical Evidence

Bench testing only. The drapes were evaluated for liquid barrier performance and classification according to the ANSI/AAMI PB-70:2003 standard, resulting in categorization into Level 2 or Level 4 performance levels.

Technological Characteristics

Composed of various non-woven fabrics and films. Categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction. Designed for single-use as a physical barrier against bloodborne pathogens and microbial contamination.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination during various surgical procedures, including angiography, cardiovascular/thoracic, ENT/plastic surgery, OB/gynecology, laparoscopic, laparotomy, orthopaedic, urology, cranial, nephroscopy, pediatric, and other general surgical procedures.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• BARRIER® Surgical Drapes (pre-amendment devices)
• K760807
• K760902
• K760933
• K760937
• K780282
• K780839A
• K780840A
• K780841A
• K780842A
• K780843A
• K780844A
• K780856A

Submission Summary (Full Text)

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K051625

# 510(k) SUMMARY

JUL 1 4 2005

| Applicant: | Mölnlycke Health Care<br>826 Newtown Yardley Rd.<br>Newtown, PA 18940 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Clay<br>Regulatory Affairs Officer |
| Tel.: | 267-685-2078 |
| Fax: | 267-685-2010 |
| Device Name: | Proprietary Name: Barrier® Surgical Drapes<br>Common/Usual Name: Surgical Drapes<br>Device Classification: Class II - 21 CFR 878.4370 (KKX) |
| Substantial Equivalence: | For the purpose of Section 510(k) of the Federal Food, Drug and<br>Cosmetic Act, Mölnlycke Health Care considers the BARRIER®<br>Surgical Drape are substantially equivalent in composition,<br>function and intended use to the previously marketed BARRIER®<br>Surgical Drapes. The original BARRIER® Brand surgical drapes<br>were pre-amendment devices manufactured by Johnson and<br>Johnson Medical. |
| | The first premarket notifications (K760807, K760902, K760933,<br>K760937) were submitted in 1976 to cover the products already on<br>the market. In 1978, additional submissions (K780282,<br>K780839A, K780840A, K780841A, K780842A, K780843A,<br>K780844A, K780856A) were made for modifications to the fabric<br>in various surgical drape configurations to the Fabric 450® non-<br>woven fabric used in the pre-amendment surgical gowns. Since<br>1978, several modifications and additions to the drape families<br>have been made to the Barrier® drapes and packs, which have<br>been cleared through multiple 510(k) submissions. |
| Intended Use: | BARRIER® surgical drapes are intended for single use to be used<br>as a protective patient covering, such as to isolate a site on a<br>surgical incision from microbial and other contamination. |

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## BARRIER® Surgical Drapes 510(k) Summary, Page 2

- The BARRIER® Surgical Drapes have been designed with an Description: assortment of fabrics, films and other materials and have been on the market for a number of years, cleared under multiple 510(k) notifications. BARRIER® surgical drapes, drape components and assorted surgical drape packs have been developed for a variety of surgical procedures including: Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology. Laparascopic. Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures. BARRIER® Surgical Drapes have been designed with materials. which provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials.
### Summary of BARRIER® Surgical Drapes have been evaluated using the Testing: ANSI/AAMI PB-70:2003 Standard. (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities)

The Barrier® Surgical Drapes are categorized into the following product groups: Patient Drapes, Equipment Drapes and Drape Components. All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2005

Mr. John Clay Regulatory Affairs Officer Molnlycke Health Care, Incorporated 826 Newton-Yardley Road Newton, Pennsylvania 18940

Re: K051625

Trade/Device Name: BARRIER® Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: June 17, 2005 Received: June 21, 2005

Dear Mr. Clay:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottowed your sected 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 Intersule conmisers prices 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 the rederal I vou, Drag, Drag, therefore, market the device, subject to the general approvisions 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 If your dovice is classified (oss as additional controls. Existing major regulations affecting (111), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device A may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Clay

Please be advised that FDA's issuance of a substantial equivalence determination does not I tease be ad rised that 22 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of all , I out of the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ibsing (21 Cr 11 the quality systems (QS) regulation (21 CFR Part 820); and if requirents as 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) rms leter 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), n you donto the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entitied, "Miserantial information on your responsibilities under the Act from the may 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/industry/support/index.html.

Sincerely yours.

Clare

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

510(k) Number (if known): < 05/625

Device Name: BARRIER® Surgical Drapes

Indications for Use:

BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __X__ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murphy, R. 2/2/05

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control. Dental Devices

510(k) Number. A053625

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