Stretchease

GUDID 10850015524018

Stretchease Powder-Free Nitrile Examination Gloves, Size Small, 1000/CS

THOMAS SCIENTIFIC, LLC

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

• Primary Device ID: 10850015524018
• NIH Device Record Key: de5b2a9d-79ac-44e4-9660-fd88bbb2efcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stretchease
• Version Model Number: 1159G04-NI
• Company DUNS: 080887713
• Company Name: THOMAS SCIENTIFIC, LLC
• 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: 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	00850015524011 [Primary]
GS1	00850015524813 [Unit of Use]
GS1	10850015524018 [Package]; Contains: 00850015524011; 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]

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• 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