sup medic

GUDID 08101601828948

Supmedics Inc.

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

• Primary Device ID: 08101601828948
• NIH Device Record Key: 225e8d8f-153f-43dd-9620-981150d962bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sup medic
• Version Model Number: SKF-L-4304
• Company DUNS: 107150886
• Company Name: Supmedics Inc.
• Device Count: 1
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08101601828948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212578

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: 2026-02-02
• Device Publish Date: 2026-01-23

On-Brand Devices [sup medic]

• 00850049592437: SKF01304
• 08101601829792: SKF-L-1302
• 08101601828948: SKF-L-4304
• 08101601828252: SKF-XL-2305
• 08101601828184: SKF-L-2304