Xpert SPK-SGXN

GUDID 00841277109122

Nitrile Exam Glove, PF SAMPLE PACK

SEMPERMED USA, INC.

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

• Primary Device ID: 00841277109122
• NIH Device Record Key: 85958c30-d2b9-48e6-baae-e497e69c6302
• Commercial Distribution Discontinuation: 2025-01-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Xpert
• Version Model Number: SPK-SGXN
• Catalog Number: SPK-SGXN
• 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	00841277109061 [Primary]
GS1	00841277109122 [Unit of Use]

FDA Product Code

• LZC: Medical Glove, Specialty

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: 2025-02-03
• Device Publish Date: 2025-01-24

On-Brand Devices [Xpert]

• 00841277109122: Nitrile Exam Glove, PF SAMPLE PACK
• 00841277109115: Nitrile Exam Glove, PF size XXL
• 00841277109108: Nitrile Exam Glove, PF size XL
• 00841277109092: Nitrile Exam Glove, PF size L
• 00841277109085: Nitrile Exam Glove, PF size m
• 00841277109078: Nitrile Exam Glove, PF size S