FDA 510 k Submission for Latex and Nitrile gloves (Surgical / Examination)

A 510k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510k notification is three months, but it may take six months or more, depending on how perfect your 510k documentation is. FDA published guidance documents for latex and nitrile (examination and surgical) gloves 510k submission.

Contents of examination and surgical gloves (Latex and Nitrile) 510k Notification

  • FDA Form 3601 - Medical Device User Fee Cover Sheet
  • FDA Form 3514 -CDRH Premarket Review Submission Cover Sheet
  • Table of Content
  • 510 k Cover Letter
  • Indications for Use Statement
  • 510 k Summary
  • Truthful and Accuracy Statement
  • Declarations of Conformity
  • Executive Summary
  • Device Description
  • Special label claim
  • Protein content claim
  • Color flavor additives
  • Donning powder
  • Brief description of manufacturing
  • Latex / Nitrile compounding Recipe
  • Substantial Equivalence Discussion
  • Label, Labeling, and Advertising
  • Sterilization and Shelf Life
  • Biocompatibility testing
  • Physical property testing
  • 1000 ml water testing

It is always recommended to get assistance from an experienced FDA consultant in 510 k documentation and submission, which will help avoid unnecessary delays in 510k clearance.

LMG can assist you in test requirements, documentation, submission, and US Agent service for Latex / Nitrile examination and surgical gloves 510k notification.

FDA Classification for examination and surgical gloves

Biocompatibility tests required for examination and surgical gloves

Physical tests required for examination and surgical gloves

US FDA Medical Device Labeling Requirements - Gloves

US FDA 510K Submission Format

FDA publishes all 510k clearance on the FDA website; you can find substantial equivalence letters at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letters.

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