supmedic

GUDID 08101601830446

Supmedics Inc.

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

• Primary Device ID: 08101601830446
• NIH Device Record Key: 8ff73fb0-0593-40cd-bb56-1426cbf139e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: supmedic
• Version Model Number: SNP-S-5312
• 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	08101601830446 [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 [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)
• 00850049592444: SKF01305
• 00850049592420: SKF01303
• 00850049592413: SKF01302
• 00810160181668: SKF1305
• 00810160181651: SKF1304
• 00810160181644: SKF1303
• 00810160181637: SKF1302
• 08500495926592: SKF-M-9303
• 08500495922082: SKF-S-9302
• 08500495921238: SKF-L-9304
• 08101601831436: SNP-XL-6315
• 08101601831368: SNP-L-6314
• 08101601831290: SNP-M-6313
• 08101601831122: SNP-S-6312
• 08101601830682: SNP-L-5314-100
• 08101601830514: SNP-M-5313
• 08101601830446: SNP-S-5312
• 08101601830378: SNP-XS-5311
• 08101601829860: SKF-XL-1302
• 08101601829624: SKF-M-1302
• 08101601829556: SKF-S-1302
• 08101601829006: SKF-XL-4305
• 08101601828870: SKF-M-4303
• 08101601828702: SKF-S-4302
• 08101601828016: SKF-M-2303
• 08101601827958: SKF-S-2302
• 00850049592130: SKF-XL-9305