Shamrock

GUDID 10641932303509

Shamrock Supreme 30350 Nitrile Examination Powder Free Textured Gloves, Blue, XSmall, Box of 100

Shamrock Marketing Co., Inc.

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

• Primary Device ID: 10641932303509
• NIH Device Record Key: 15898844-1b3e-4467-bcf5-ee37fe6c6369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shamrock
• Version Model Number: 30350/100
• Company DUNS: 010206618
• Company Name: Shamrock Marketing Co., 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00641932303502 [Primary]
GS1	10641932303509 [Package]; Contains: 00641932303502; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052382

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: 2021-05-18
• Device Publish Date: 2021-05-10

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