Super-X

GUDID 00811114030940

Powder-Free Latex Examination Gloves

Unisafe Inc.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 00811114030940
• NIH Device Record Key: 7d009b0b-d02f-444e-ba6e-221b64d64618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Super-X
• Version Model Number: SPRX500S
• Company DUNS: 080171627
• Company Name: Unisafe Inc.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811114030902 [Primary]
GS1	00811114030940 [Package]; Contains: 00811114030902; Package: Shipper Carton [10 Units]; In Commercial Distribution
GS1	10811114030909 [Unit of Use]

FDA Product Code

• LYY: Latex Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-05
• Device Publish Date: 2022-09-16

On-Brand Devices [Super-X]

• 00811114030971: Powder-Free Latex Examination Gloves
• 00811114030964: Powder-Free Latex Examination Gloves
• 00811114030957: Powder-Free Latex Examination Gloves
• 00811114030940: Powder-Free Latex Examination Gloves