TH-Glove

GUDID G196709791

Nitrile Gloves, (Chemo-rated), Small

Anham Usa, Inc.

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

• Primary Device ID: G196709791
• NIH Device Record Key: 058f3882-5c52-44b4-90e2-1e19bfd8b559
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TH-Glove
• Version Model Number: Nitrile Gloves, (Chemo-rated), Small
• Company DUNS: 142361489
• Company Name: Anham Usa, 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
HIBCC	G196709791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102846

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: 2022-01-11
• Device Publish Date: 2022-01-03

On-Brand Devices [TH-Glove]

• G196709831: Nitrile Gloves, Chemo-Rated, X-Small
• G196709821: Nitrile Gloves, (Chemo-rated), X-Large
• G196709811: Nitrile Gloves, (Chemo-rated), Large
• G196709801: Nitrile Gloves, (Chemo-rated), Medium
• G196709791: Nitrile Gloves, (Chemo-rated), Small