FDA 510(k) Consultant for Nitrile & Latex Gloves – Examination & Surgical

Examination and surgical gloves are classified as Class 1 medical devices in FDA medical device classification database. Most class 1 devices are exempted from 510(k) clearance requirements, but both examination and surgical gloves need FDA 510(k) clearance to market in the USA. FDA product code for surgical gloves is KGO, and nitrile patient examination glove is LZA. Nitrile and latex gloves – examination and surgical – must also comply with GMP requirements.

Why do I need an FDA 510(k) consultant for my glove 510(k) submission?

A 510(k) clearance is a lengthy and costly process, FDA review time for a 510(k) is 90 days, and the review clock will stop whenever there is a question or clarification needed on the submission; in standard practice, it may take 3-5 months to complete the review.

A 510(k) submission must include all relevant test reports; for nitrile and latex gloves 510(k), a biocompatibility testing report with approved protocol is mandatory. These tests are costly and time-consuming. A failure in the tests or using the wrong protocol or testing standard will result in the determination of NSE (Not Substantially Equivalent) and need a new 510(k) submission. Of course, you must pay the same review fee again and wait another 3-5 months.

Missing documents is another common issue that delays the 510(k) process. There are certain requirements for 510(k) documentation, including the list of documents that must be present in the submission; missing any required documents will result in an FDA hold on the submission, and the review clock will start only after the FDA receives the documents.

An experienced 510(k) consultant can guide you in identifying the test requirements and corresponding standards. 510(k) consultants can also ensure that all the required documents are included in the submission, which will help you save time and money.

Why do we choose LMG as our 510(k) consultant for the nitrile and latex glove 510(k) submission?

• LMG has been assisting with FDA regulations since 2009.
• We have completed more than 50 gloves 510k submissions in recent years.
• We are based in the USA, so it is easy to communicate with FDA.
• We will guide you in test requirements and testing standards.
• We will review the documents before we compile the 510(k) notification.
• We will prepare and submit the 510k notification to FDA.
• LMG will be the contact for 510k review questions.

FDA 510(k) Test requirements for latex and nitrile gloves

• 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 Clearances are public information; below are the recently submitted 510(k)’s by LMG