GP CRAFT

GUDID 00810120950624

BLACK NITRILE EXAM GLOVES, X-LARGE

Diamond Gloves

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

• Primary Device ID: 00810120950624
• NIH Device Record Key: 7cc42cec-007a-4f4a-8dfb-ad0e8a6918de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GP CRAFT
• Version Model Number: GP2004
• Company DUNS: 052262122
• Company Name: Diamond Gloves
• Device Count: 100
• 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: true
• 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	00810120950600 [Unit of Use]
GS1	00810120950617 [Primary]
GS1	00810120950624 [Package]; Contains: 00810120950617; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182528

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: 2023-02-17
• Device Publish Date: 2023-02-09

On-Brand Devices [GP CRAFT]

• 00810120950624: BLACK NITRILE EXAM GLOVES, X-LARGE
• 00810120950594: BLACK NITRILE EXAM GLOVES, LARGE
• 00810120950563: BLACK NITRILE EXAM GLOVES, MEDIUM
• 00810120950532: BLACK NITRILE EXAM GLOVES, SMALL