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Medical Device

FDA Medical Device Class I

FDA Registration - Latex and Nitrile gloves

FDA regulates latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration, and device listing to market in the USA. Powdered gloves are not allowed to market in the USA for medical purposes.

FDACE PRO Provide assistance to latex and nitrile glove manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes


Prepare 510k notification

Submission of 510k notification

FDA Agent service for 510k submission

Guidance in test requirements

Register your medical device establishment with FDA

List your glove with FDA.

FDA Classification for examination and surgical gloves

  Regulation Number

   Product Code

    Glove Type

866.2120

   JTM

Anaerobic Box Glove

880.6250

   OPI

Antimicrobial Medical Glove

880.6250

   QDO

Fentanyl And Other Opioid Protection Glove

880.6250

   LYY

Latex Patient Examination Glove

880.6250

   OPJ

Medical Gloves With Chemotherapy Labeling Claims

880.6250

   FMC

Patient Examination Glove

880.6250

   LZC

Patient Examination Glove, Specialty

880.6250

   LZA

Polymer Patient Examination Glove

880.6250

   OIG

Guayle Rubber Examination Glove

878.4460

   OPA

Non-Natural Rubber Latex Surgeon's Glove

880.6250

   OPC

Polychloroprene Patient Examination Glove

880.6250

   OPH

Radiation Attenuating Medical Glove

892.6500

   IWP

Radiographic Protective Glove

878.4460

   KGO

Surgeon's Gloves

880.6250

   LYZ

Vinyl Patient Examination Glove