LUXSPA Large nitrile disposable exam gloves

GUDID 00860009297760

Size Large.Single use nitrile disposable exam gloves.

Beltway Nail Supply, LLC

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

• Primary Device ID: 00860009297760
• NIH Device Record Key: 7bb28666-92a7-4ec7-a556-446bd8d4d1eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUXSPA Large nitrile disposable exam gloves
• Version Model Number: 0001
• Company DUNS: 068047800
• Company Name: Beltway Nail Supply, LLC
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009297760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

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: 2022-11-29
• Device Publish Date: 2022-11-21

On-Brand Devices [LUXSPA Large nitrile disposable exam gloves]

• 10860009297767: Size Large. Case of 10 boxes. Single use nitrile disposable exam gloves.
• 00860009297760: Size Large.Single use nitrile disposable exam gloves.