Sense8x

GUDID 00810054580751

Nitrile Exam Gloves

Stauffer Manufacturing Company

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 00810054580751
• NIH Device Record Key: 3d36f589-20c8-4356-a4a4-58a66759c5cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sense8x
• Version Model Number: 8005PFB 2X
• Company DUNS: 002336204
• Company Name: Stauffer Manufacturing Company
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810054580751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161929

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-12
• Device Publish Date: 2023-01-04

On-Brand Devices [Sense8x]

• 00810054580751: Nitrile Exam Gloves
• 00810054580737: Nitrile Exam Gloves
• 00810054580713: Nitrile Exam Gloves
• 00810054580706: Nitrile Exam Gloves
• 00810054580683: Nitrile Exam Gloves