SemperSure Green Nitrile Exam Glove SUNG201

GUDID 00841277105391

SemperSure Green Nitrile Exam Glove, size XS

SEMPERMED USA, INC.

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

• Primary Device ID: 00841277105391
• NIH Device Record Key: 335ef0aa-8504-44fb-8f3d-d0c3c9ab7d54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SemperSure Green Nitrile Exam Glove
• Version Model Number: SUNG201
• Catalog Number: SUNG201
• Company DUNS: 004072158
• Company Name: SEMPERMED USA, INC.
• Device Count: 200
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: true

Customer Support Contacts

• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com
• Phone: 800-366-9545
• Email: Glove.Info@SempermedUSA.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841277105391 [Primary]
GS1	00841277105438 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183441

FDA Product Code

• OPJ: Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

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: 2020-01-27
• Device Publish Date: 2020-01-17

On-Brand Devices [SemperSure Green Nitrile Exam Glove]

• 00841277105490: SemperSure Green Nitrile Exam Glove, size XL
• 00841277105476: SemperSure Green Nitrile Exam Glove, sample pack
• 00841277105421: SemperSure Green Nitrile Exam Glove, size L
• 00841277105414: SemperSure Green Nitrile Exam Glove, size M
• 00841277105407: SemperSure Green Nitrile Exam Glove, size S
• 00841277105391: SemperSure Green Nitrile Exam Glove, size XS