FDA Registration - Latex and Nitrile gloves - FDA 510K Submission

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.

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 is public information; you can find the clearance letter at the FDA site. Below are examples of glove 510k clearance letters.