polymer patient examination glove - RayaNit

GUDID 06974289400353

Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Raya Pharmaceuticals LLC

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

• Primary Device ID: 06974289400353
• NIH Device Record Key: b6cc8ce9-aca5-429a-be0b-ab268175b7dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: polymer patient examination glove - RayaNit
• Version Model Number: Large
• Company DUNS: 106631637
• Company Name: Raya Pharmaceuticals 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974289400353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211319

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: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [polymer patient examination glove - RayaNit]

• 06974289400360: Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical p
• 06974289400353: Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical p
• 06974289400223: Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical p