NES PLUTO POWDER FREE NITRILE EXAMINATION GLOVES

GUDID D89260705514200

MAXILL, INC.

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

• Primary Device ID: D89260705514200
• NIH Device Record Key: b2543d90-df03-40ca-a10f-6e85e407ce9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES PLUTO POWDER FREE NITRILE EXAMINATION GLOVES
• Version Model Number: 51420
• Company DUNS: 079343581
• Company Name: MAXILL, INC.
• Device Count: 3000
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D89260705514200 [Unit of Use]
HIBCC	D89260705514201 [Primary]
HIBCC	D89260705514202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001619

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: 2022-05-31
• Device Publish Date: 2022-05-23

On-Brand Devices [NES PLUTO POWDER FREE NITRILE EXAMINATION GLOVES]

• D89260705514240: 51424
• D89260705514230: 51423
• D89260705514220: 51422
• D89260705514210: 51421
• D89260705514200: 51420