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

A 510 k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510 k notification is 3 months, but in reality, it may take 6 months or more depends 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 / 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 of an experienced FDA consultant in 510 k documentation and submission, which will help to avoid unnecessary delay 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 publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are examples of examination and surgical glove 510k clearance letter

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