DEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX LG 431224

GUDID D7664312242

Smarthealth, Inc.

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

• Primary Device ID: D7664312242
• NIH Device Record Key: 2ad8ced3-744e-4c59-9af3-2e06050bdbb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX LG
• Version Model Number: 431224
• Catalog Number: 431224
• Company DUNS: 061081477
• Company Name: Smarthealth, Inc.
• Device Count: 300
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7664312240 [Unit of Use]
HIBCC	D7664312241 [Primary]
HIBCC	D7664312242 [Package]; Contains: D7664312241; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171422

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: 2022-12-06
• Device Publish Date: 2022-11-28

Devices Manufactured by Smarthealth, Inc.

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• D7664311092 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG: 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG*200
• D7664311102 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL: 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL*200
• D766408712 - QUALITOUCH LATEX PF EXAM NATURAL CF XS*: 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF XS*100
• D766408722 - QUALITOUCH LATEX PF EXAM NATURAL CF SM: 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF SM*100