THE SAFETY ZONE B340GREP-XL-1

GUDID B340GREPXL1

Small Latex Powder Free Exam Glove

IMPACT PRODUCTS, LLC

Hevea-latex surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: B340GREPXL1
• NIH Device Record Key: afc7bf3d-c373-4206-9e41-bbc07fe3d9e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THE SAFETY ZONE
• Version Model Number: GREP-XL-1
• Catalog Number: B340GREP-XL-1
• 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	B340GREPXL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022016

FDA Product Code

• LYY: Latex 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: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [THE SAFETY ZONE]

• B340GREPXL1: Small Latex Powder Free Exam Glove
• B340GREPSM1: Small Latex Powder Free Exam Glove
• B340GREPMD1: Medium Latex Powder Free Exam Glove
• B340GREPLG1: Large Latex Powder Free Exam Glove