TravelShield

GUDID 10342509000103

Nitrile Exam Gloves

Wessco International Ltd., A California Limited Partnership

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

• Primary Device ID: 10342509000103
• NIH Device Record Key: d92cc684-117d-4d22-b8f7-8f93e6fecae7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TravelShield
• Version Model Number: L
• Company DUNS: 118553619
• Company Name: Wessco International Ltd., A California Limited Partnership
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00342509000106 [Primary]
GS1	10342509000103 [Package]; Contains: 00342509000106; Package: case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981
• Premarket Notification: K121526

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: 2022-09-28
• Device Publish Date: 2022-09-20