Diversamed 8645S

GUDID B3408645S1

Small Nitrile Powder Free Exam Glove

IMPACT PRODUCTS, LLC

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

• Primary Device ID: B3408645S1
• NIH Device Record Key: 05e5dd26-37c9-4c85-9f7f-4a2fb2f8e32c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diversamed
• Version Model Number: 8645S
• Catalog Number: 8645S
• Company DUNS: 005052360
• Company Name: IMPACT PRODUCTS, LLC
• 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: false
• 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	B3408645S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [Diversamed]

• B3408641XL1: Extra Large Nitrile Powder Free Exam Glove
• B3408641L1: Small Nitrile Power Free Exam Glove
• B3408607XL1: XL Vinyl Power Free Exam Glove
• B3408607S1: Small Vinyl Power Free Exam Glove
• B3408607M1: Medium Vinyl Power Free Exam Glove
• B3408607L1: Large Vinyl Power Free Exam Glove
• B3408641S1: Small Nitrile Powder Free Exam Glove
• B3408641M1: Medium Latex Power Free Exam Glove
• B3408628XL1: Extra Large Nitrile Powder Free Exam Glove
• B3408628M1: Medium Nitrile Powder Free Exam Glove
• B3408628L1: Large Nitrile Powder Free Exam Glove
• B3408617XL1: Extra Large Vinyl Stretch Exam Glove
• B3408617S1: Small Vinyl Powder Free Exam Glove
• B3408617M1: Medium Vinyl Stretch Exam Glove
• B3408617L1: 8617L
• B3408622XL1: Extra Large Latex Powder Free Exam Glove
• B3408622S1: Small Latex Powder Free Exam Glove
• B3408622M1: Medium Latex Powder Free Exam Glove
• B3408622L1: Large Latex Powder Free Exam Glove
• B3408645XL1: Extra Large Nitrile Powder Free Exam Glove
• B3408645S1: Small Nitrile Powder Free Exam Glove
• B3408645M1: Medium Nitrile Powder Free Exam Glove
• B3408649XL1: Extra Large Nitrile Powder Free Exam Glove
• B3408649S1: Small Nitrile Powder Free Exam Glove
• B3408649M1: Medium Nitrile Powder Free Exam Glove