AMBITEX LXL240

GUDID 10699320107956

AMBITEX LATEX EXAM PF XL

Tradex International, Inc.

Nitrile examination/treatment glove, non-powdered, sterile

• Primary Device ID: 10699320107956
• NIH Device Record Key: 84f519f1-f2df-4804-8631-0b059218d71d
• Commercial Distribution Discontinuation: 2021-10-21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMBITEX
• Version Model Number: LXL240
• Catalog Number: LXL240
• Company DUNS: 196027981
• Company Name: Tradex International, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00699320107959 [Primary]
GS1	10699320107956 [Package]; Contains: 00699320107959; Package: CASE [10 Units]; Discontinued: 2021-10-21; In Commercial Distribution
GS1	30699320107950 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051404

FDA Product Code

• LYY: Latex patient examination glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-20
• Device Publish Date: 2019-04-05

On-Brand Devices [AMBITEX]

• 10699320702557: AMBITEX STRETCH VINYL PF
• 10699320702540: AMBITEX STRETCH VINYL PF LG
• 10699320702533: AMBITEX STRETCH VINYL PF MD
• 10699320702526: AMBITEX STRETCH VINYL PF SM
• 10699320202057: AMBITEX VINYL PF XL
• 10699320202040: AMBITEX VINYL PF LG
• 10699320202033: AMBITEX VINYL MD PF
• 10699320202026: AMBITEX VINYL PF SM
• 10699320107956: AMBITEX LATEX EXAM PF XL
• 10699320107949: AMBITEX LATEX EXAM PF LG
• 10699320107932: AMBITEX LATEX EXAM PF MD
• 10699320107925: AMBITEX LATEX EXAM PF SM
• 10699320107918: AMBITEX LATEX EXAM PF XS
• 10699320102258: AMBITEX LATEX HIGH RISK EXAM XL
• 10699320102241: AMBITEX LATEX HIGH RISK EXAM PF LG
• 10699320102234: AMBITEX LATEX HIGH RISK EXAM PF MD
• 10699320102227: AMBITEX LATEX HIGH RISK EXAM SM
• 20699320452008: NITRILE EXAM PF 10/12/10 FM
• 10699320102142: AMBITEX LATEX EXAM GLV PF LG
• 00699320334706: 33470-4
• 10699320000196: AMBITEX NITRILE EXAM GREEN PF SM 10/100
• 10699320000233: AMBITEX NITRILE EXAM GREEN PF XL 10/100
• 10699320000158: AMBITEX NITRILE EXAM GREEN PF MD 10/100
• 10699320000073: AMBITEX NITRILE EXAM GREEN PF LG 10/100