Blackwork

GUDID 20850002097126

Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, M

Blackwork Worldwide LLC

Polychloroprene examination/treatment glove, non-powdered

• Primary Device ID: 20850002097126
• NIH Device Record Key: ff6cb4f0-5cd3-4252-8f47-5761e4a3530a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blackwork
• Version Model Number: 1030
• Company DUNS: 045085221
• Company Name: Blackwork Worldwide LLC
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	00850002097122 [Unit of Use]
GS1	10850002097129 [Primary]
GS1	20850002097126 [Package]; Contains: 10850002097129; Package: 100/bx, 10 bx/cs [10 Units]; In Commercial Distribution

FDA Product Code

• OPC: Powder-Free Polychloroprene 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: 2023-05-03
• Device Publish Date: 2023-01-30

On-Brand Devices [Blackwork]

• 20850002097140: Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, XL
• 20850002097133: Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, L
• 20850002097126: Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, M
• 20850002097119: Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, S
• 20850002097102: Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, XS