SemperForce Blue Nitrile Exam Glove SPK-BKLF

GUDID 00841277105926

SemperForce Blue Nitrile Exam Glove, sample pack

SEMPERMED USA, INC.

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

• Primary Device ID: 00841277105926
• NIH Device Record Key: 4a72c3a2-dc01-4031-aa65-bed23cdf2655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SemperForce Blue Nitrile Exam Glove
• Version Model Number: SPK-BKLF
• Catalog Number: SPK-BKLF
• Company DUNS: 004072158
• Company Name: SEMPERMED USA, INC.
• Device Count: 6
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841277105902 [Primary]
GS1	00841277105926 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171378

FDA Product Code

• LZA: Polymer Patient Examination Glove
• 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: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [SemperForce Blue Nitrile Exam Glove]

• 00841277105926: SemperForce Blue Nitrile Exam Glove, sample pack
• 00841277105896: SemperForce Blue Nitrile Exam Glove, size XL
• 00841277105889: SemperForce Blue Nitrile Exam Glove, size L
• 00841277105872: SemperForce Blue Nitrile Exam Glove, size M
• 00841277105865: SemperForce Blue Nitrile Exam Glove, size S