Saniderm

GUDID 03850004625771

Saniderm Medical, LLC

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

• Primary Device ID: 03850004625771
• NIH Device Record Key: 5967d216-0ebf-42ac-a5d1-cfcf96e20640
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saniderm
• Version Model Number: Black Nitrile M Size 100PCS
• Company DUNS: 037310126
• Company Name: Saniderm Medical, LLC
• 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: false
• 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	00850004625774 [Primary]
GS1	03850004625771 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121526
• Premarket Notification: K123869

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: 2024-02-12
• Device Publish Date: 2024-02-02

On-Brand Devices [Saniderm]

• 03850004625818: Black Nitrile XL Size 100PCS
• 03850004625795: Black Nitrile L Size 100PCS
• 03850004625771: Black Nitrile M Size 100PCS
• 03850004625757: Black Nitrile S Size 100PCS
• 03850004625733: Black Nitrile XS Size 100PCS