microdot® Flex Black

Basic Information

• Brand Name: microdot® Flex Black
• Primary DI: 00847713001456
• Version / Model: 1604-10
• Company Name: Cambridge Sensors USA LLC
• Labeler DUNS: 962314360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-12-12
• Public Version: 1
• Public Version Date: 2025-12-22
• Public Version Status: New
• Public Device Record Key: 9586ef64-47d3-46f9-b974-58820b984336

Device Description

microdot® Flex Black Nitrile X-Large Gloves

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZA	Polymer Patient Examination Glove	General Hospital	880.6250	1
LZC	Medical Glove, Specialty	General Hospital	880.6250	1
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	880.6250	1
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47176	Vinyl examination/treatment glove, non-powdered	A non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00847713001494	GS1	Case	10	In Commercial Distribution
Primary	00847713001456	GS1
Unit of Use	00847713001418	GS1

Premarket Submissions

Submission Number	Supplement Number
K222294	000