FDA Registration - Latex and Nitrile gloves

FDA regulate 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 purpose.

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

LMG 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.

Test requirements for latex and nitrile gloves for US FDA 510K Submission

Biocompatibility tests required for examination and surgical gloves

Physical tests required for examination and surgical gloves

Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification

US FDA Medical Device Labeling Requirements - Gloves

FDA 510K Clearance are public information, you can find clearance letter at FDA site. Below are examples of glove 510k clearance letter