Blackwork

Basic Information

• Brand Name: Blackwork
• Primary DI: 10850002097006
• Version / Model: 2010
• Company Name: Blackwork Worldwide LLC
• Labeler DUNS: 045085221
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-01-30
• Public Version: 1
• Public Version Date: 2023-02-07
• Public Version Status: New
• Public Device Record Key: 0c3a60a4-6dcd-43d8-bfda-961f598e09eb

Device Description

Gloves, Exam, Latex, Non-Sterile, Powder-Free, Textured, Black, XS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYY	Latex Patient Examination Glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47172	Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial	A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850002097003	GS1	100/bx, 10 bx/cs	10	In Commercial Distribution
Primary	10850002097006	GS1
Unit of Use	00850002097009	GS1