Sentinel Guardian - Nitrile

GUDID 10850036973062

Non-sterile powder free nitrile exam glove size extra large

Life Science Products, Inc.

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

• Primary Device ID: 10850036973062
• NIH Device Record Key: d6087a7d-05fe-4aba-9253-8967c2d6702c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentinel Guardian - Nitrile
• Version Model Number: G-GNF12-Xl
• Company DUNS: 119697365
• Company Name: Life Science Products, Inc.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850036973065 [Primary]
GS1	00850036973072 [Unit of Use]
GS1	10850036973062 [Package]; Contains: 00850036973065; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161929

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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [Sentinel Guardian - Nitrile]

• 10850036973307: Non-sterile powder free nitrile exam glove size 2xl
• 00850036973294: Non-sterile powder free nitrile exam glove size extra large
• 10850036973260: Non-sterile powder free nitrile exam glove size large
• 10850036973246: Non-sterile powder free nitrile exam glove size medium
• 10850036973222: Non-sterile powder free nitrile exam glove size small
• 10850036973109: Non-sterile powder free nitrile exam glove size extra small
• 10850036973086: Non-sterile powder free nitrile exam glove size 2x-large
• 10850036973062: Non-sterile powder free nitrile exam glove size extra large
• 10850036973048: Non-sterile powder free nitrile exam glove size large
• 10850036973024: Non-sterile powder free nitrile exam glove size medium
• 10850036973000: Non-sterile powder free nitrile exam glove size small
• 10850036973321: Blue non-sterile Nitrile exam glove, medium duty - Size Sm
• 10850036973338: Blue non-sterile Nitrile exam glove, medium duty - Size Med
• 10850036973383: Blue Non-Sterile Nitrile Exam Glove; Medium Duty - Size Xlg
• 10850036973345: Blue non-sterile Nitrile exam glove, medium duty - Size Lg