DIAMOND GLOVES-ADVANCE IF48

GUDID 00850043630890

IF48 Powder Free Vinyl Examination Gloves (Clear), LARGE

Diamond Gloves

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00850043630890
• NIH Device Record Key: a5e10f25-bdf3-4437-be05-d6398a1aebd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAMOND GLOVES-ADVANCE IF48
• Version Model Number: VEPF-48L
• Company DUNS: 052262122
• Company Name: Diamond Gloves
• 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	00850043630616 [Unit of Use]
GS1	00850043630852 [Primary]
GS1	00850043630890 [Package]; Contains: 00850043630852; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072227

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: 2022-11-21
• Device Publish Date: 2022-11-11

On-Brand Devices [DIAMOND GLOVES-ADVANCE IF48]

• 00850043630883: IF48 Powder Free Vinyl Examination Gloves (Clear), EXTRA-LARGE
• 00850043630890: IF48 Powder Free Vinyl Examination Gloves (Clear), LARGE
• 00850043630906: IF48 Powder Free Vinyl Examination Gloves (Clear), MEDIUM
• 00850043630913: IF48 Powder Free Vinyl Examination Gloves (Clear), SMALL