Bulline

GUDID 00850044093014

Steer Sourcing, Inc.

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

• Primary Device ID: 00850044093014
• NIH Device Record Key: 3e7e9bef-5a47-4d09-9bd6-3b657ba935c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bulline
• Version Model Number: B3502
• Company DUNS: 118153673
• Company Name: Steer Sourcing, Inc.
• 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044093014 [Primary]
GS1	00850044093069 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

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: 2022-10-25
• Device Publish Date: 2022-10-17

On-Brand Devices [Bulline]

• 00850044093090: B3505
• 00850044093038: B3504
• 00850044093021: B3503
• 00850044093014: B3502
• 00850044093007: B3501