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 |