AURA

GUDID 26976739561922

Premium Nitrile Examination Gloves L

Guangdong KINGFA SCI.&TECH. Co., Ltd.

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

• Primary Device ID: 26976739561922
• NIH Device Record Key: 920ad8ba-c59f-40a8-a1d7-1e464365b75c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURA
• Version Model Number: KG-1801(GNL-XM)
• Company DUNS: 543265548
• Company Name: Guangdong KINGFA SCI.&TECH. Co., Ltd.
• Device Count: 100
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976739561928 [Unit of Use]
GS1	16976739561925 [Primary]
GS1	26976739561922 [Package]; Contains: 16976739561925; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203593

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: 2024-08-19
• Device Publish Date: 2024-08-09

On-Brand Devices [AURA]

• 26976739561939: Premium Nitrile Examination Gloves XL
• 26976739561922: Premium Nitrile Examination Gloves L
• 06976739561911: Premium Nitrile Examination Gloves M
• 16976739561901: Premium Nitrile Examination Gloves S