At the end of November, SUNGO successfully helped a domestic medical device enterprise obtain 510K approval for condoms! It only took 3 months from the end of August to the end of November when the approval document was submitted!

At the end of November, SUNGO successfully helped a domestic medical device enterprise obtain 510K approval for condoms! It only took 3 months from the end of August to the end of November when the approval document was submitted!

Condom product market

According to relevant statistics at the beginning of 2022, the global condom market size in 2021 was 9.9 billion US dollars, and is expected to expand at a compound annual growth rate of 8.52% from 2022 to 2030. Increased awareness of condom use, availability of different types of condoms to meet consumer demand, and measures to reduce the spread of HIV and other sexually transmitted infections are expected to contribute to market growth during the forecast period.

Latex condoms accounted for the largest share of 2021 revenue, with an estimated value of $8.78 billion. The latex condom market is expected to grow significantly in the coming period as new products are introduced and baby boomers age. Currently, most brands on the market are made with latex, a form of natural rubber, which is longer lasting, more flexible, and provides effective contraception and protection against sexually transmitted diseases.

Product label

The U.S. Food and Drug Administration classifies the male condom as a Class II medical device, requiring a 510 (K) declaration. The product code is HIS. Here's a look at some of the essentials of declaring a 510K.

Because of the specific intended use of condoms, the FDA has strict labeling requirements for the product. In general, product identification is divided into product packaging and instructions. Product packaging is divided into four categories, aluminum film packaging, retail packaging, medium packaging and transportation packaging.

In addition to the identification requirements for general medical devices, such as product name, model, manufacturer information, and storage conditions, all product labels should show the expiration date of the product that meets the aging test results. If the product is made of latex, users also need to be reminded that "this product contains latex".

Given the possible risks associated with condom use, the FDA also recommends risk reduction measures for different risks.

Risk 1: Unwanted pregnancy

Action: Labels need to remind users that although condoms are intended to prevent pregnancy, using the product does not eliminate the risk of pregnancy, and that users should use the product correctly. In addition, the label should inform users to consult a health care professional if they have any questions about contraception. Finally, manufacturers should provide the percentage of women in the United States who used condoms but had an unintended pregnancy in the past year and the percentage of women who used other methods of contraception but had an unintended pregnancy.

Risk 2: Sexually Transmitted Infections (STI)

Action: Manufacturers should indicate on the presentation that the intended use of the product includes prevention of HIV/AIDS and other STIs, but does not eliminate the risk of STIs, and remind users of the proper use of the product. Labels should state that condoms remain the most effective measure for reducing STIs, such as HIV/AIDS and gonorrhea, and that condoms are less effective against sexually transmitted infections such as human papillomavirus (HPV) and herpes, which can also be transmitted through contact with infected skin that is not covered by condoms.

Risk 3: Incorrect or non-consistent condom use increases the chance of unwanted pregnancy and STI transmission

Action: Sign and display adequate instructions for use and precautions against error or non-continuous use.

Description of raw materials and additives

The raw materials of the product, such as latex and other additives, product processing AIDS, such as lubricants and spacers should be described in detail.

Product testing


The biocompatibility endpoint of the product should be evaluated and the biocompatibility test items should be confirmed based on the nature of the product's contact with human beings.

Product performance testing

Products shall be tested for performance according to ISO 4074 and ASTM D3492. The test items include dimensions, leaky holes, physical properties and many other tests.

Product validity test

Unlike other medical devices that require aging testing according to ASTM F1980, the FDA requires manufacturers to perform aging testing in accordance with U.S. Regulation 21 CFR 801.435. Perform three batches of product aging test and ensure that the product performance and packaging meet the standard requirements before and after aging.

SUNGO can provide manufacturers with a package of US compliance services including condom testing protocols, product testing, US agents, 510K applications, business registration and product listing.

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