Disposable Gloves Size L

GUDID 04007418924511

A device made of vinyl intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is covered with powder to facilitate donning/removal; it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Hans Hepp GmbH & Co. KG

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• Primary Device ID: 04007418924511
• NIH Device Record Key: 0bf18b1a-df6c-466b-a32c-b8688518f006
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Gloves Size L
• Version Model Number: 92401
• Company DUNS: 315896217
• Company Name: Hans Hepp GmbH & Co. KG
• Device Count: 4
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04007418924016 [Primary]
GS1	04007418924511 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170575

FDA Product Code

• LYZ: Vinyl 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: 2023-08-21
• Device Publish Date: 2023-08-11

On-Brand Devices [Disposable Gloves Size L]

• 04007418924528: A device made of vinyl intended as a protective barrier when worn on the hands of healthcare pro
• 04007418924511: A device made of vinyl intended as a protective barrier when worn on the hands of healthcare pro