Josen

GUDID 00850042242100

Sino City USA LLC

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

• Primary Device ID: 00850042242100
• NIH Device Record Key: ed5f9888-e0ec-45aa-8ec5-f60409213366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Josen
• Version Model Number: Disposable Nitrile Examination Gloves Blue M3.5-M
• Company DUNS: 118715921
• Company Name: Sino City USA LLC
• 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: true
• 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	00850042242100 [Primary]
GS1	10850042242107 [Package]; Package: carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Josen]

• 00850042242209: Disposable Vinyl Synthetic Gloves Black M5.0-S (10
• 00850042242193: Disposable Vinyl Synthetic Gloves Black M5.0-M (10
• 00850042242186: Disposable Vinyl Synthetic Gloves Black M5.0-L (10
• 00850042242179: Disposable Vinyl Synthetic Gloves Black M5.0-XL (1
• 00850042242162: Disposable Vinyl Synthetic Gloves Blue M5.0-XL (10
• 00850042242155: Disposable Vinyl Synthetic Gloves Blue M5.0-L (100
• 00850042242148: Disposable Vinyl Synthetic Gloves Blue M5.0-M (100
• 00850042242131: Disposable Vinyl Synthetic Gloves Blue M5.0-S (100
• 00850042242124: Disposable Nitrile Examination Gloves Blue M3.5-XL
• 00850042242117: Disposable Nitrile Examination Gloves Blue M3.5-L
• 00850042242100: Disposable Nitrile Examination Gloves Blue M3.5-M
• 00850042242094: Disposable Nitrile Examination Gloves Blue M3.5-S
• 00850042242087: Disposable Nitrile Examination Gloves Blue M3.5-XS
• 00850042242070: Disposable Vinyl Examination M5.0-XL (100pcs)
• 00850042242063: Disposable Vinyl Examination M5.0-L (100 pcs)
• 00850042242056: Disposable Vinyl Examination M5.0-M (100 pcs)
• 00850042242049: Disposable Vinyl Examination M5.0-S
• 10850042242312: NME1335J
• 10850042242305: NME1334J
• 10850042242299: NME1333J
• 10850042242282: NME1332J
• 00850042242278: NME1331J
• 10850042242626: NME1231J
• 10850042242619: NME1232J
• 10850042242602: NME1233J
• 85004224259900: NME1234J
• 10850042242589: NME1235J