# K153016: aoni Natural Rubber Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Guangzhou Daming United Rubber Products, Ltd.
- Decided: Oct 20, 2016 after 371 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: 6 generations back to K952415 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120394: Lifestyles Zero Lubricated Latex Condom, Ansell Heathcare Products, LLC (2012) Summary page 4.

## Indications for use
aoni Natural Rubber Latex Condom [Smooth/Dotted/Combined] a) Smooth 52mm/54mm/55mm natural b) Dotted 52mm natural c) Combined [smooth+girdling] 52mm natural d) Combined [dotted+girdling] 52mm natural The Condom is used for contraception and for prophylactic purpose ( to help prevent pregnancy and the transmission of sexually transmitted infections.)

Source page: https://510kreport.com/device/K153016
Methodology: https://510kreport.com/methodology