# K220576: FAMA Male Latex Condoms

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Personage Hygiene Products Co., Ltd.
- Decided: Aug 5, 2022 after 158 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 K897129 (1990). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162919: Male Latex Condoms, Zhejiang Xiangban Latex Products Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K262108: FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO (2026), 0 descendants of its own
- K232279: LifeStyles NRL Textured Condom (2023), 0 descendants of its own

## Indications for use
The FAMA Male Latex Condoms are used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K220576
Methodology: https://510kreport.com/methodology