ALPHA

GUDID 00810007199894

Elite Safety Products

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

• Primary Device ID: 00810007199894
• NIH Device Record Key: 090a3a92-ed6f-4a96-be0e-984ecc0b60af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPHA
• Version Model Number: IS-6040MD (2XL)
• Company DUNS: 082745034
• Company Name: Elite Safety Products
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007199894 [Primary]
GS1	00810007199948 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

FDA Product Code

• FMC: 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: 2022-08-08
• Device Publish Date: 2022-07-31

On-Brand Devices [ALPHA]

• 00810007199894: IS-6040MD (2XL)
• 00810007199887: IS-6040MD (XL)
• 00810007199870: IS-6040MD (L)
• 00810007199863: IS-6040MD (M)
• 00810007199856: IS-6040MD (S)