BLUZEN

GUDID 08106760337270

Medium Black Extra Strength 5 mil Nitrile Gloves

Remcoda, LLC

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

• Primary Device ID: 08106760337270
• NIH Device Record Key: 8d97bc90-bec0-494b-9ea2-336f213ae9f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUZEN
• Version Model Number: NIT104M
• Company DUNS: 117130169
• Company Name: Remcoda, 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08106760337270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-23
• Device Publish Date: 2023-01-19

On-Brand Devices [BLUZEN]

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• 08106760343738: LARGE BLUE EXAMINATION 6 MIL NITRILE GLOVE
• 08106760343660: MEDIUM BLUE EXAMINATION 6 MIL NITRILE GLOVE
• 08106760343592: Small Blue Examination 6 mil Nitrile Gloves
• 08106760343424: XTRA XTRA LARGE BLUE EXAMINATION 6MIL NITRILE GLOVE
• 08106760343356: XTRA LARGE BLACK EXAMINATION 6 MIL NITRILE GLOVE
• 08106760343288: LARGE BLACK EXAMINATION 6 MIL NITRILE GLOVE
• 08106760343110: MEDIUM BLACK EXAMINATION 6 MIL NITRILE GLOVE
• 08106760343042: SMALL BLACK EXAMINATION 6 MIL NITRILE GLOVE
• 08106760338024: XL Blue Extra Strength 5 mil Nitrile Gloves
• 08106760337966: Large Blue Extra Strength 5 mil Nitrile Gloves
• 08106760337898: Medium Blue Extra Strength 5 mil Nitrile Gloves
• 08106760337720: Small Blue Extra Strength 5 mil Nitrile Gloves
• 08106760337416: XL Black Extra Strength 5 mil Nitrile Gloves
• 08106760337348: Large Black Extra Strength 5 mil Nitrile Gloves
• 08106760337270: Medium Black Extra Strength 5 mil Nitrile Gloves
• 08106760337102: Small Black Extra Strength 5 mil Nitrile Gloves
• 00798234016750: XTRA XTRA LARGE BLACK EXAMINATION 6 MIL NITRILE GLOVE
• 00850047976321: XTRA XTRA LARGE BLACK EXAMINATION 6 MIL NITRILE GLOVE
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• 00810676034304: Disposable Gloves, Blue, Exam, Nitrile, Small, 100pcs/cs, BluZen
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• 00810676033796: Disposable Gloves, Blue, Extra Strength, Nitrile, Large, 100 pcs, BluZen
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• 00810676033741: Disposable Gloves, Black, Extra Strength, Nitrile, Extra Large, 100 pcs, BluZen
• 00810676033734: Disposable Gloves, Black, Extra Strength, Nitrile, Large, 100 pcs, BluZen
• 00810676033727: Disposable Gloves, Black, Extra Strength, Nitrile, Medium, 100 pcs, BluZen
• 00810676033710: Disposable Gloves, Black, Extra Strength, Nitrile, Small, 100 pcs, BluZen
• 10850053807128: Disposable Gloves, Blue, Hybrid, Nitrile, Extra Large, 100 pcs/cs, BluZen
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