VersaFlex

GUDID 00811114031213

Powder-Free Nitrile Examination Gloves

UNISAFE INC.

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

• Primary Device ID: 00811114031213
• NIH Device Record Key: dde5b48e-62a3-4112-adfe-0524630f654a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaFlex
• Version Model Number: VF500L
• 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	00811114031169 [Primary]
GS1	00811114031213 [Package]; Contains: 00811114031169; Package: Shipper Carton [10 Units]; In Commercial Distribution
GS1	10811114031166 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172015

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: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [VersaFlex]

• 00811114031237: Powder-Free Nitrile Examination Gloves
• 00811114031220: Powder-Free Nitrile Examination Gloves
• 00811114031213: Powder-Free Nitrile Examination Gloves
• 00811114031206: Powder-Free Nitrile Examination Gloves
• 00811114031190: Powder-Free Nitrile Examination Gloves