HANDCOVERS

GUDID 00850051992232

4 Mil Powder-Free Black Nitrile Gloves, Size XL

Balco Industries Inc.

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

• Primary Device ID: 00850051992232
• NIH Device Record Key: 2446dbb4-dd84-4a3e-87ed-fa3e514d4fc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANDCOVERS
• Version Model Number: BKN4004
• 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	00850051992225 [Primary]
GS1	00850051992232 [Package]; Contains: 00850051992225; Package: [10 Units]; In Commercial Distribution
GS1	30850051992226 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123869
• Premarket Notification: K133307

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: 2023-07-10
• Device Publish Date: 2023-07-01

On-Brand Devices [HANDCOVERS]

• 00850051992157: 6 Mil Powder-Free Black Nitrile Gloves, Size XL
• 00850051992133: 6 Mil Powder-Free Black Nitrile Gloves, Size Large
• 00850051992119: 6 Mil Powder-Free Black Nitrile Gloves, Size Medium
• 00850051992096: 6 Mil Powder-Free Black Nitrile Gloves, Size Small
• 00850051992072: 4 Mil Powder-Free Blue Nitrile Gloves, Size XL
• 00850051992058: 4 Mil Powder-Free Blue Nitrile Gloves, Size Large
• 00850051992034: 4 Mil Powder-Free Blue Nitrile Gloves, Size Medium
• 00850051992010: 4 Mil Powder-Free Blue Nitrile Gloves, Size Small
• 00850051992232: 4 Mil Powder-Free Black Nitrile Gloves, Size XL
• 00850051992218: 4 Mil Powder-Free Black Nitrile Gloves, Size Large
• 00850051992195: 4 Mil Powder-Free Black Nitrile Gloves, Size Medium
• 00850051992171: 4 Mil Powder-Free Black Nitrile Gloves, Size Small
• 00850051992256: 4 Mil Powder-Free Rose Nitrile Gloves, Size Small
• 00850051992317: 4 Mil Powder-Free Rose Nitrile Gloves, Size Xlarge
• 00850051992294: 4 Mil Powder-Free Rose Nitrile Gloves, Size Large
• 00850051992270: 4 Mil Powder-Free Rose Nitrile Gloves, Size Medium