# 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

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Personage Hygiene Products Co., Ltd.
- Decided: Sep 21, 2026 after 90 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: 5 generations back to K897129 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220576: FAMA Male Latex Condoms, Shanghai Personage Hygiene Products Co., Ltd. (2022) Summary page 6.

## Indications for use
The FAMA/MO/Mingliu Male Natural Rubber Latex Condoms — Aqueous Lubricant are used for contraception and prophylactic purposes (to help prevent pregnancy and sexually transmitted infections).

Source page: https://510kreport.com/device/K262108
Methodology: https://510kreport.com/methodology