Stretchease

GUDID 30850015524043

Stretchease Powder-Free Nitrile Examination Gloves, Size 2X-Large, 900/CS

THOMAS SCIENTIFIC, LLC

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

• Primary Device ID: 30850015524043
• NIH Device Record Key: ad32a072-6fc7-43ee-85e8-b1716f102153
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stretchease
• Version Model Number: 1159G13-NI
• Company DUNS: 080887713
• Company Name: THOMAS SCIENTIFIC, LLC
• Device Count: 90
• 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	00850015524837 [Unit of Use]
GS1	00850015524844 [Primary]
GS1	30850015524043 [Package]; Contains: 00850015524844; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141590

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: 2022-04-18
• Device Publish Date: 2022-04-08

On-Brand Devices [Stretchease]

• 30850015524043: Stretchease Powder-Free Nitrile Examination Gloves, Size 2X-Large, 900/CS
• 10850015524414: Stretchease Powder-Free Nitrile Examination Gloves, SML Sample Pack, 150/CS
• 10850015524049: Stretchease Powder-Free Nitrile Examination Gloves, Size Ex-Large, 900/CS
• 10850015524032: Stretchease Powder-Free Nitrile Examination Gloves, Size Large, 1000/CS
• 10850015524025: Stretchease Powder-Free Nitrile Examination Gloves, Size Medium, 1000/CS
• 10850015524018: Stretchease Powder-Free Nitrile Examination Gloves, Size Small, 1000/CS
• 10850015524001: Stretchease Powder-Free Nitrile Examination Gloves, Size Ex-Small, 1000/CS