Elastex PF Nitrile Glove 1033341

GUDID 10304040056964

Elastex PF Nitrile Glove LARGE

HENRY SCHEIN, INC.

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

• Primary Device ID: 10304040056964
• NIH Device Record Key: 823d1ba8-8bb7-4cc3-b66d-0884733cbcc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elastex PF Nitrile Glove
• Version Model Number: 1033341
• Catalog Number: 1033341
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 100
• DM Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *FALSE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040056967 [Primary]
GS1	10304040056964 [Package]; Contains: 00304040056967; Package: [10 Units]; In Commercial Distribution
GS1	20304040056961 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152937

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: 2020-01-16
• Device Publish Date: 2020-01-08

On-Brand Devices [Elastex PF Nitrile Glove]

• 10304040057008: Elastex PF Nitrile Glove X-SMALL
• 10304040056995: Elastex PF Nitrile Glove X LARGE
• 10304040056988: Elastex PF Nitrile Glove SMALL
• 10304040056971: Elastex PF Nitrile Glove MEDIUM
• 10304040056964: Elastex PF Nitrile Glove LARGE