# K994118: Osmanthus, Kongfu, and Gobon, Natural Rubber Latex Condoms

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Latex Factory
- Decided: Aug 14, 2000 after 252 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Latex Lubricated Condom: named in the summary without a submission number
- (no number) Latex Condom with Spermicidal Lubricant: named in the summary without a submission number

## Most influential descendants
- K050360: Tulip Condom (2005), 0 descendants of its own

## Recalls of this device
- Sep 11, 2007 · Not classified · Z-0054-2008: Condoms fail the water leak test and package integrity

## Indications for use
The Osmanthus and Gobon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K994118
Methodology: https://510kreport.com/methodology