Safe .R World NPFBIO351L563

GUDID 00860009074552

Nitrile Powder Free Biodegradable Glove 3.5g 4.0m Large Box of 200

Safe.R World Corporation

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

• Primary Device ID: 00860009074552
• NIH Device Record Key: bf4855b9-e9b0-40c8-a04d-5fe876b466f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe .R World
• Version Model Number: NGPF Biodegradable 3.5g 4.0m Large
• Catalog Number: NPFBIO351L563
• Company DUNS: 048020664
• Company Name: Safe.R World Corporation
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com
• Phone: 603-560-7546
• Email: Johnette@saferworlds.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009074552 [Primary]
GS1	00860011258407 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	10860009074559 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071910

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: 2023-03-15
• Device Publish Date: 2023-03-07

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• 00860011258452: Nitrile Powder Free Examination Glove, Single Use, 6.2 gram, Medium, Tested for Use with Chemoth
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