Reflex

GUDID 00811114031138

Powder-Free Vinyl Examination Gloves

UNISAFE INC.

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00811114031138
• NIH Device Record Key: dbc39337-5fba-4b50-9bf6-ff119d92f400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reflex
• Version Model Number: RF500XL
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811114031091 [Primary]
GS1	00811114031138 [Package]; Contains: 00811114031091; Package: Shipper Carton [10 Units]; In Commercial Distribution
GS1	10811114031098 [Unit of Use]

FDA Product Code

• LYZ: Vinyl 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: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [Reflex]

• 00811114031138: Powder-Free Vinyl Examination Gloves
• 00811114031121: Powder-Free Vinyl Examination Gloves
• 00811114031114: Powder-Free Vinyl Examination Gloves
• 00811114031107: Powder-Free Vinyl Examination Gloves