IP Products IPNGK-801

GUDID 00860009907669

Glove PF Nitrile Exam Black Small 10/100

IP Products

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

• Primary Device ID: 00860009907669
• NIH Device Record Key: c69a5003-4c54-4460-8739-6cd156a24555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IP Products
• Version Model Number: IPNGK-801
• Catalog Number: IPNGK-801
• Company DUNS: 151890902
• Company Name: IP Products
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009907621 [Primary]
GS1	00860009907669 [Package]; Contains: 00860009907621; Package: [10 Units]; In Commercial Distribution
GS1	00860010093702 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

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: 2023-03-28
• Device Publish Date: 2023-03-20

On-Brand Devices [IP Products]

• 00860009119833: Glove PF Nitrile Exam Blue XLarge 10/100
• 00860009119826: Glove PF Nitrile Exam Blue Large 10/100
• 00860009119819: Glove PF Nitrile Exam Blue Medium 10/100
• 00860009119888: Glove PF Nitrile Exam Blue Small 10/100
• 00860010093733: Glove PF Nitrile Exam Black X-Large 10/100
• 00860010093726: Glove PF Nitrile Exam Black Large 10/100
• 00860010093719: Glove PF Nitrile Exam Black Medium 10/100
• 00860009907669: Glove PF Nitrile Exam Black Small 10/100
• 00860010093740: Glove PF Nitrile Exam Black XX-Large10/100