Health-Tec/DHP Pure Touch 100 Nitrile Gloves 430-30052

GUDID D773430300521

Health-Tec/DHP Pure Touch 100 Nitrile Gloves Size X-Large 100/box

Dental Health Products Inc

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

• Primary Device ID: D773430300521
• NIH Device Record Key: f1d60932-834a-4289-8c79-5bb854203b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec/DHP Pure Touch 100 Nitrile Gloves
• Version Model Number: 430-30052
• Catalog Number: 430-30052
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773430300521 [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: 2022-09-29
• Device Publish Date: 2022-09-21

On-Brand Devices [Health-Tec/DHP Pure Touch 100 Nitrile Gloves]

• D773430300521: Health-Tec/DHP Pure Touch 100 Nitrile Gloves Size X-Large 100/box
• D773430300421: Health-Tec/DHP Pure Touch 100 Nitrile Gloves Size Large 100/box
• D773430300321: Health-Tec/DHP Pure Touch 100 Nitrile Gloves Size Medium 100/box
• D773430300221: Health-Tec/DHP Pure Touch 100 Nitrile Gloves Size Small 100/box