HANDCOVERS

GUDID 00850051992256

4 Mil Powder-Free Rose Nitrile Gloves, Size Small

Balco Industries Inc.

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

• Primary Device ID: 00850051992256
• NIH Device Record Key: f575d305-2f82-4369-99f2-ab5a75f1edd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANDCOVERS
• Version Model Number: PNK4001
• Company DUNS: 055891774
• Company Name: Balco Industries 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: true
• 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	00850051992249 [Primary]
GS1	00850051992256 [Package]; Contains: 00850051992249; Package: [10 Units]; In Commercial Distribution
GS1	30850051992240 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222103

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: 2024-06-24
• Device Publish Date: 2024-06-15

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• 00850051992232: 4 Mil Powder-Free Black Nitrile Gloves, Size XL
• 00850051992218: 4 Mil Powder-Free Black Nitrile Gloves, Size Large
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• 00850051992256: 4 Mil Powder-Free Rose Nitrile Gloves, Size Small
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