# K103119: Billy Boy Male Latex Condom

- Pathway: 510(k) (Traditional)
- Applicant: Sheila Pickering PHD
- Decided: Feb 24, 2011 after 125 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K952415 (1996). 16 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081413: Twinlotus and Shields Natural Rubber Latex Condom, Dailian Latex Company, Ltd. (2008) Summary page 1.
- K943064: Kimono (Condoms), Mayer Laboratories (1995) Summary page 1.
- K904375: Kimono Plus, Mayer Laboratories (1990) Summary page 1.
- K073016: Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm Sensations Lubricant, Church & Dwight Co., Inc. (2007) Summary page 1.
- K071313: Trojan-Enz Brand, Church & Dwight Co., Inc. (2007) Summary page 1.
- K071272: Trojan Thintensity Brand Male Latex Condom, Church & Dwight Co., Inc. (2007) Summary page 1.
- K023405: Trojan Mint Tingle Brand Latex Condoms, Armkel, LLC (2002) Summary page 1.

## Most influential descendants
- K120394: Lifestyles Zero Lubricated Latex Condom (2012), 1 descendant of its own
- K111093: Billy Boy Male Latex Condom (2011), 1 descendant of its own
- K153016: aoni Natural Rubber Latex Condom (2016), 0 descendants of its own
- K141256: Okamoto Studded Condom (2014), 0 descendants of its own
- K120287: Trojan Magnum Condom with Fire & Ice Lubricant (2012), 0 descendants of its own

## Indications for use
The Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.

Source page: https://510kreport.com/device/K103119
Methodology: https://510kreport.com/methodology