FDA 510(k) Consultant for Nitrile 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 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 glove 510(k) submission?

  • LMG has been assisting with FDA regulations since 2009.
  • We have completed more than 40 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

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

It depends on the device code and classification; most class 1 devices are exempted from 510k requirements, but examination and surgical gloves come under 510k requirements.

Standard 510(k) review time for all medical devices is identical, 90 days, but it may be longer for higher-risk devices. If the submission is perfect for nitrile gloves, you may get the clearance before 90 days.

No, 90 days is the FDA review time from the date FDA receives the submission.

We need one month to review and prepare the documents if you already have the test reports and required documents.

Yes, you can include multiple sizes of gloves in one submission.

LMG is the most experienced 510(k) consultant for gloves; we have completed over forty 510(k) clearances in recent years exclusively for examination and surgical gloves, including latex and nitrile. You can verify the 510k’s in the above 510k number links.

No, FDA will not send any registration certificate; you will get a 510k clearance letter from FDA.

Yes, the 510(k) owner can transfer the 510k as part of the company acquisition; after transferring the 510k, the new owner needs to list the device under their FDA establishment registration.

510(k) clearance is valid forever. If there is no change to the device, labeling, or intended use. There is no annual renewal for 510(k).


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LIBERTY MANAGEMENT GROUP LTD.

75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : +1 (630) 270-2921
Fax : +1 (815) 986-2632
E-mail : info@fdahelp.us



FDA Glove Classification – Product Codes

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