SUPMEDIC

GUDID 00810160180463

Powder Free Nitrile Examination Gloves (L size)

Supmedics Inc.

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

• Primary Device ID: 00810160180463
• NIH Device Record Key: ac952bac-7126-47fc-a5f7-545e516caeda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPMEDIC
• Version Model Number: SKF 4304
• Company DUNS: 107150886
• Company Name: Supmedics 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: 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 Dimensions

• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter
• Width: 110 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810160180425 [Primary]
GS1	00810160180463 [Package]; Contains: 00810160180425; Package: carton [10 Units]; In Commercial Distribution
GS1	00810160182016 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213040

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: 2025-02-20
• Device Publish Date: 2025-02-12

On-Brand Devices [SUPMEDIC]

• 00810160180395: SKF03301
• 00810160180388: SKF03304
• 00810160180371: SKF03303
• 00810160180364: SKF03302
• 00810160180357: SKF3301
• 00810160180340: SKF3304
• 00810160180333: SKF3303
• 00810160180326: SKF3302
• 00810160180319: SKF02305
• 00810160180302: SKF02304
• 00810160180296: SKF02303
• 00810160180289: SKF02302
• 00810160180272: SKF2305
• 00810160180265: SKF2304
• 00810160180258: SKF2303
• 00810160180241: SKF2302
• 00810160180111: BTN3441
• 00810160180104: BTN3444
• 00810160180463: Powder Free Nitrile Examination Gloves (L size)
• 00810160180456: Powder Free Nitrile Examination Gloves (M size)
• 00810160181996: Powder Free Nitrile Examination Gloves (S size)