Dermatec Vinyl GL+603VINPF

GUDID 10813417020601

Dermatec Clear Vinyl PF exam glove large 100/box, 10 box/case

Relda, Llc.

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 10813417020601
• NIH Device Record Key: 70ede904-e2c6-4faa-aa1a-6635a036c1e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermatec Vinyl
• Version Model Number: GL+603VINPF
• Catalog Number: GL+603VINPF
• Company DUNS: 101926900
• Company Name: Relda, Llc.
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813417020604 [Primary]
GS1	10813417020601 [Package]; Contains: 00813417020604; Package: box [10 Units]; In Commercial Distribution
GS1	70813417020603 [Unit of Use]

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: 2022-09-13
• Device Publish Date: 2022-09-05

On-Brand Devices [Dermatec Vinyl]

• 10813417020601: Dermatec Clear Vinyl PF exam glove large 100/box, 10 box/case
• 10813417020595: Dermatec Clear Vinyl PF exam glove medium 100/box, 10 box/case
• 10813417020588: Dermatec Clear Vinyl PF exam glove small 100/box, 10 box/case
• 10813417020571: Dermatec Clear Vinyl PF exam glove small 100/box, 10 box/case
• 10813417020564: Dermatec Clear Vinyl PF exam glove xsmall 100/box, 10 box/case