Bulk Pax

GUDID 00037182133547

Powder-free Exam Grade Black Nitrile Glove - Size X-Large

Bulk Pax

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: 00037182133547
• NIH Device Record Key: 050dc032-5795-4d56-be1c-d99f8c04831c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bulk Pax
• Version Model Number: HEAT-XL
• Company DUNS: 132477840
• Company Name: Bulk Pax
• 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: true
• 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	00037182133493 [Primary]
GS1	00037182133547 [Package]; Contains: 00037182133493; Package: [10 Units]; In Commercial Distribution
GS1	00793945409044 [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: 2023-02-24
• Device Publish Date: 2023-02-16

On-Brand Devices [Bulk Pax]

• 00037182133547: Powder-free Exam Grade Black Nitrile Glove - Size X-Large
• 00037182133530: Powder-free Exam Grade Black Nitrile Glove - Size Large
• 00037182133523: Powder-free Exam Grade Black Nitrile Glove - Size Medium
• 00037182133462: Powder-free Exam Grade Black Nitrile Glove - Size Small