Health-Tec/DHP Pure Touch Nitrile Gloves 430-N300XL

GUDID D773430N300XL1

Health-Tec/DHP Pure Touch Nitrile Gloves X-Large 300/box

Dental Health Products Inc

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

• Primary Device ID: D773430N300XL1
• NIH Device Record Key: 04509bc4-5aab-4a6b-990b-325158509aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec/DHP Pure Touch Nitrile Gloves
• Version Model Number: 430-N300XL
• Catalog Number: 430-N300XL
• Company DUNS: 623191194
• Company Name: Dental Health Products Inc
• 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: 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	D773430N300XL1 [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: 2022-09-08
• Device Publish Date: 2022-08-31

On-Brand Devices [Health-Tec/DHP Pure Touch Nitrile Gloves]

• D773430N300XS1: Health-Tec/DHP Pure Touch Nitrile Gloves X-Small 300/box
• D773430N300XL1: Health-Tec/DHP Pure Touch Nitrile Gloves X-Large 300/box
• D773430N300S1: Health-Tec/DHP Pure Touch Nitrile Gloves Small 300/box
• D773430N300M1: Health-Tec/DHP Pure Touch Gloves Medium 300/box
• D773430N300L1: Health-Tec/DHP Pure-Touch Nitrile Gloves Large 300/box