Health-Tec/DHP Pure Touch 200 Nitrile Gloves 430-200S

GUDID D773430200S1

Health-Tec/DHP Pure Touch 200 Nitrile Gloves Size Small 200/box

Dental Health Products Inc

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

• Primary Device ID: D773430200S1
• NIH Device Record Key: b2290995-4b8f-4388-91d8-9d8a78176c0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec/DHP Pure Touch 200 Nitrile Gloves
• Version Model Number: 430-200S
• Catalog Number: 430-200S
• 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	D773430200S1 [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 200 Nitrile Gloves]

• D773430200XS1: Health-Tec/DHP Pure Touch 200 Nitrile Gloves Size X-Small 200/box
• D773430200XL1: Health-Tec/DHP Pure Touch 200 Nitrile Gloves Size X-Large 200/box
• D773430200S1: Health-Tec/DHP Pure Touch 200 Nitrile Gloves Size Small 200/box
• D773430200M1: Health-Tec/DHP Pure Touch 200 Nitrile Gloves Size Medium 200/box
• D773430200L1: Health-Tec/DHP Pure Touch 200 Nitrile Gloves Size Large 200/box