Disposable Lab Coats BLUE FLUID RESISTANT | KNIT COLLAR & CUFF | SNAP FRONT CLOSURE Large /extra Large
McKesson - 34181200
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 IdentifiersDevice Id: 40612479120394
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20612479191123
Package Quantity: 30
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 20612479191123
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
Device Id: 10612479236360
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