Beastek

GUDID 00810160180166

Supmedics Inc.

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

• Primary Device ID: 00810160180166
• NIH Device Record Key: 1294c1b6-b664-4bc8-8e28-21639cb0b166
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beastek
• Version Model Number: BTN02442
• Company DUNS: 107150886
• Company Name: Supmedics 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: 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	00810160180166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213040

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: 2024-10-10
• Device Publish Date: 2024-10-02

On-Brand Devices [Beastek]

• 00810160180197: BTN02445
• 00810160180180: BTN02444
• 00810160180173: BTN02443
• 00810160180166: BTN02442
• 00810160180074: BTN2445
• 00810160180067: BTN2444
• 00810160180043: BTN2442
• 00810160180050: BTN2443
• 00810160180159: BTN01445
• 00810160180142: BTN01444
• 00810160180135: BTN01443
• 00810160180128: BTN01442
• 00810160180036: BTN1445
• 00810160180029: BTN1444
• 00810160180012: BTN1443
• 00810160180005: BTN1442