FDA 510 K Submission - Condom

The U.S. Food and Drug Administration (FDA) regulates condoms as medical devices and requires manufacturers to comply with the 510(k) premarket notification requirements before marketing them in the United States.

The 510(k) process involves submitting a notification to the FDA demonstrating that the condom is substantially equivalent to a legally marketed device (i.e., a predicate device) that is already on the market. The manufacturer must provide information on the materials, design, performance, and labeling of the condom, as well as any potential risks associated with its use.

The FDA also requires that condoms meet certain performance standards, including:

  1. Strength and reliability: The condom must be able to withstand a certain amount of pressure without breaking or tearing, and must be reliably effective in preventing pregnancy and sexually transmitted infections.

  2. Biocompatibility: The materials used in the condom must be safe and not cause adverse reactions in users.

  3. Labeling: The labeling must provide accurate and clear information about the condom's use, instructions, and precautions.

  4. Packaging: The packaging must protect the condom from damage and contamination, and must be tamper-evident.

Once the FDA reviews and approves the 510(k) notification, the manufacturer can market the condom in the United States. The FDA also monitors the safety and effectiveness of condoms on an ongoing basis and can take action if any safety issues arise.

FDA Classification for Condoms

Regulation Number

Condom Code

Condom Class

Condom Type

884.5320

LZL

Class 3

Micro-Condom

884.5330

OBY

Class 3

female condom

884.5300

HIS

Class 2

Condom

884.5310

LTZ

Class 2

Condom With Nonoxynol-9

884.5340

MBU

Class 2

Single-Use Internal Condom

884.5300

MOL

Class 2

Condom, Synthetic

884.5300

MSC

Class 2

Barrier, Std, Oral Sex

884.5300

NUC

Class 2

Personal Lubricant

884.5300

OKW

Class 2

Seminal Fluid Collection Kit

884.5300

PEB

Class 2

personal lubricant

884.5300

QPD

Class 2

Personal Lubricant Ring

884.5305

QRZ

Class 2

External Condom

LMG Provides assistance to condom manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements.

FDA 510K Clearance for condoms are public information; you can search for it on the FDA website. Below are examples of condom 510k clearances

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare condom 510k notification
  • Submission of condom 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your establishment with FDA
  • List your condom with FDA.

US FDA 510K Submission Requirements

FDA 510K Consultant