PRESBYTERIAN LINEN SERVICES SURGICAL PACKS

K970286 · Medline Industries, Inc. · LRO · Mar 10, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970286
• Device Name: PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
• Applicant: Medline Industries, Inc.
• Product Code: LRO · General, Plastic Surgery
• Decision Date: Mar 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.

Device Story

Presbyterian Linen Services Surgical Packs consist of reusable gowns, drapes, and towels; customized per customer procedure specifications. Used in operating rooms by surgical personnel. Function as sterile barriers to prevent microbial/fluid transfer between patient and staff; towels provide fluid absorption and hand drying. No electronic or automated components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Reusable surgical gowns, drapes, and towels. Materials and construction identical to predicate devices. Sterilization method not specified.

Indications for Use

Indicated for use in surgical procedures to provide sterile barriers (gowns, drapes, towels) for protection of patients and operating room personnel against microbial and fluid contamination.

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

• AMSCO Sterile Recoveries Surgical Packs (K932522)
• Associated Hospital Services, Inc. Surgical Packs (K935199)
• Medline’s Repeat Performance Surgical Pack System (K930700)

Submission Summary (Full Text)

{0}

MAR 10 1997
11
Presbyterian Healthcare System

Presbyterian Hospital
200 Hawthorne Lane
Post Office Box 33549
Charlotte, NC 28233-3549
[phone]
http://www.presbyterian.org

# SUMMARY OF SAFETY AND EFFECTIVENESS

January 21, 1997
K970286

1. Regulatory Information
Device Name: Surgical Procedure Packs
Proprietary: Presbyterian Linen Surgical Procedure Packs
Common: Surgical Packs
Classification: Surgical Procedure Packs

2. Submitted on behalf of Presbyterian Linen by:

Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
Phone: [phone]
Fax: [phone]
Contact Person: Lara N. Simmons
See Attached Letter of Authorization

Presbyterian Linen Services’ Surgical Packs are substantially equivalent to the following:

1. K932522 AMSCO Sterile Recoveries Surgical Packs
2. K935199 Associated Hospital Services, Inc. Surgical Packs
3. K930700 Medline’s Repeat Performance Surgical Pack System

Presbyterian Linen’s Surgical Packs are virtually identical to the predicate devices listed above. The gowns, towels and drapes are of the same material and construction. There are no technological differences between the Presbyterian Linen packs and the predicate devices.

## Device Description

Presbyterian Linen Services Surgical Packs are packs composed of reusable gowns, drapes, and toweling, the specifics of which are tailored to the customer’s specifications for that procedure.

## Intended Use:

Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.

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