Glove, Exam Nitrile Blue CONFIDERM 6.8C PF Small 9” CUFF

Glove, Exam Nitrile Blue CONFIDERM 6.8C PF Small 9” CUFF
McKesson - 14-6N62C

A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; 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 patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QDA

Device Name: Electrocardiograph Software For Over-The-Counter Use

Device Class: 2

Physical State: The devices uses consumer grade electronics and is hand held or worn on the wrist, arms, or chest.

Definition: An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses input from leads attached to or in contact with the users hands, wrists, arms, or chest to detect potential differences and generate an ECG waveform.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Hands, arms, or chest.

Regulation Number: 870.2345

Third Party Flag: N

Medical Specialty: CV

Code: LZC

Device Name: Medical Glove, Specialty

Device Class: 1

Physical State: N/A

Definition: A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

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: 880.6250

Third Party Flag: Y

Medical Specialty: HO

Code: LZA

Device Name: Polymer Patient Examination Glove

Device Class: 1

Physical State: N/A

Definition: A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes 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: 880.6250

Third Party Flag: Y

Medical Specialty: HO

Device Id: 00612479249585

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00612479249578

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 00612479249578

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: 00612479249561

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