- Physicians Office Resource

Latex Surgical Gloves / Powder Free / Chemo Tested, Sterile, Textured Size 9
McKesson - 14-31090

Device Description

A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KGO

Device Name: Surgeon'S Gloves

Device Class: 1

Physical State: N/A

Definition: A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4460

Third Party Flag: Y

Medical Specialty: SU

Device Identifiers

Device Id: 00612479261426

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00612479261419

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 00612479261419

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: 00612479261433

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00612479261426

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

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