Illusion Glove Strawberry 1124994

GUDID H65811249942

Illusion Glove Strawberry Large

HENRY SCHEIN, INC.

Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile

• Primary Device ID: H65811249942
• NIH Device Record Key: 3c8d5055-bc82-49d8-acd4-8e98d9942c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illusion Glove Strawberry
• Version Model Number: 1124994
• Catalog Number: 1124994
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H65811249941 [Primary]
HIBCC	H65811249942 [Package]; Contains: H65811249941; Package: [20 Units]; In Commercial Distribution
HIBCC	H65811249949 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093496

FDA Product Code

• LYY: Latex 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: 2020-05-21
• Device Publish Date: 2020-05-13

On-Brand Devices [Illusion Glove Strawberry]

• 20304040101517: Illusion Glove Strawberry Small
• 20304040101500: Illusion Glove Strawberry Medium
• 20304040101494: Illusion Glove Strawberry Large
• 20304040101487: Illusion Glove Strawberry X-Small
• H65811249942: Illusion Glove Strawberry Large
• H65811249912: Illusion Glove Strawberry X-Small