- Physicians Office Resource

Disposable Coveralls OPEN CUFFS & ANKLES WHITE | FLUID RESISTANT | FRONT ZIPPER CLOSURE XL Extra Large
McKesson - 82131200

Device Description

A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OEA

Device Name: Non-Surgical Gown

Device Class: 1

Physical State: A gown is made of fabric material, either non-woven or woven

Definition: A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Provides minimal or low levels of barrier protection (e.g., ANSI/AAMI PB70 Level 2 or below)

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: A gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material

Regulation Number: 878.4040

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 10612479236315

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 40612479120264

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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