TACKLE

GUDID 15060887690567

Tackle

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

• Primary Device ID: 15060887690567
• NIH Device Record Key: a13ec8a2-527f-40e0-81c0-a73c70a4ae51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TACKLE
• Version Model Number: Blue Nitrile M Size 100PCS
• Company DUNS: 104622818
• Company Name: Tackle
• 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	05060887690560 [Primary]
GS1	15060887690567 [Package]; Contains: 05060887690560; Package: [10 Units]; In Commercial Distribution
GS1	35060887690561 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170136

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: 2023-08-08
• Device Publish Date: 2023-07-31

On-Brand Devices [TACKLE]

• 15060887690581: Blue Nitrile XL Size 100PCS
• 15060887690574: Blue Nitrile L Size 100PCS
• 15060887690567: Blue Nitrile M Size 100PCS
• 35060887690554: Blue Nitrile S Size 100PCS
• 15060887690543: Black Nitrile L Size 50PCS
• 15060887690536: Black Nitrile L Size 100PCS
• 15060887690529: Black Nitrile XL Size 100PCS
• 15060887690611: Black Nitrile XL Size 50PCS