sup

GUDID 08101601833898

Supmedics Inc.

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

• Primary Device ID: 08101601833898
• NIH Device Record Key: 7b1cd088-e77d-4dfc-ac24-94e8dd8057aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sup
• Version Model Number: UNE-XL-13105
• 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	08101601833898 [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: 2026-02-03
• Device Publish Date: 2026-01-26

On-Brand Devices [sup]

• 08101601833034: UNE-XL-12105
• 08101601832808: UNE-M-12103
• 08101601832730: UNE-S-12102
• 08101601832280: UNE-XL-11105
• 00810160183297: UNE-L-12104
• 00810160183211: UNE-L-11104
• 00810160183204: UNE-M-11103
• 00810160183198: UNE-S-11102
• 08101601837858: UNS-XL-14125
• 08101601837780: UNS-L-14124
• 08101601837612: UNS-M-14123
• 08101601837544: UNS-S-14122
• 08101601837094: UNM-XL-14115
• 08101601836936: UNM-L-14114
• 08101601836868: UNM-M-14113
• 08101601836790: UNM-S-14112
• 08101601836240: UNE-XL-16105
• 08101601836172: UNE-L-16104
• 08101601836004: UNE-M-16103
• 08101601835946: UNE-S-16102
• 08101601835328: UNE-L-15104
• 08101601835250: UNE-M-15103
• 08101601835182: UNE-S-15102
• 08101601834642: UNE-XL-14105
• 08101601834574: UNE-L-14104
• 08101601834406: UNE-M-14103
• 08101601834338: UNE-S-14102
• 08101601833898: UNE-XL-13105
• 08101601833720: UNE-L-13104
• 08101601833652: UNE-M-13103
• 08101601833584: UNE-S-13102
• 00810160183549: UNE-XL-15105