FDA Registration for Latex & Nitrile Gloves
FDA regulates latex and nitrile examination and surgical gloves as Class I medical devices requiring 510(k) clearance, establishment registration, and device listing to market in the USA.
FDA Registration - Latex and Nitrile gloves - FDA 510K Submission
The FDA regulates latex and nitrile gloves — both examination and surgical — as medical devices. Even though these gloves are a Class I device, they are classified as “Class I reserved,” which means they are not exempt from premarket review. To market them in the USA, a manufacturer must obtain FDA 510(k) clearance, complete medical device establishment registration, and submit a device listing. As part of the 510(k), gloves are evaluated against performance criteria such as leak resistance and physical strength to demonstrate they are substantially equivalent to a legally marketed predicate device. Powdered gloves are banned and cannot be marketed in the USA for medical purposes, following the FDA’s 2016 final rule. Foreign glove manufacturers must also appoint a U.S. FDA Agent. Gloves that enter the country without proper 510(k) clearance, registration, and listing are subject to FDA import alerts and detention.
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.
Frequently Asked Questions
Do nitrile gloves require 510(k) clearance?
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Do I need FDA establishment registration for gloves?
Need Help with Glove FDA Registration?
LMG assists glove manufacturers with 510(k) submission, establishment registration, and US FDA Agent service.
Contact LMG Contact Us- Medical Device Establishment Registration
- Premarket Notification 510(k)
- Tests Required for Examination Surgical Gloves
- FDA Labeling Requirements for Examination Surgical Gloves
- Biocompatibility Tests for Examination Surgical Gloves
- Contents of Examination Surgical Gloves
- FDA Registration for Surgical Face Masks
- FDA Premarket Approval PMA