On Guard

GUDID 00811114030070

Powder-Free Nitrile Examination Gloves

UNISAFE INC.

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

• Primary Device ID: 00811114030070
• NIH Device Record Key: 8fcc445f-5fd1-4c65-a930-d6231afaff0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Guard
• Version Model Number: ON600XL
• 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	00811114030032 [Primary]
GS1	00811114030070 [Package]; Contains: 00811114030032; Package: Shipper Carton [10 Units]; In Commercial Distribution
GS1	10811114030039 [Unit of Use]

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: 2023-03-21
• Device Publish Date: 2023-03-13

On-Brand Devices [On Guard]

• 00811114030070: Powder-Free Nitrile Examination Gloves
• 00811114030063: Powder-Free Nitrile Examination Gloves
• 00811114030056: Powder-Free Nitrile Examination Gloves
• 00811114030049: Powder-Free Nitrile Examination Gloves