Panels › Obstetrics/Gynecology › Product code HIS · Class 2
Condom
Regulation 884.5300
3510(k)s in 12 months (402 all time)
1recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in HIS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2026 | GOLD STAR DISTRIBUTION INC Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE,
TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CON Open, Classified |
HIS | K874383 |
| Aug 17, 2022 | Family Dollar Stores, Llc. LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265 Open, Classified |
HIS | None listed |
| Nov 22, 2016 | Reckitt Benckiser LLC Durex Pleasure Pack .
3 ultra fine lubricated latex condoms
12 ultra fine lubricated latex condoms
24 Ra fine lubricated latex condoms
3 ct UPC 3-02340-30042-04-1
3 ct - Walmart UPC 02340-70042- Terminated |
HIS | None listed |
| Feb 20, 2013 | Ansell Healthcare Products LLC LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303.
A sheath which completely covers the penis with a closely fitting membrane. The cond Terminated |
HIS | K120394 |
| Jan 24, 2013 | Ansell Healthcare Products LLC Lifestyles Pleasure Collection
30 Premium Lubricated Condoms
Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin.
UPC 0-70907-02625-0. Terminated |
HIS | K000408 K941258 +1 |
| Dec 11, 2007 | Global Protection Corp. Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MA Terminated |
HIS | K994118 |
| Dec 31, 2002 | Ansell Healthcare Inc Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors Terminated |
HIS | None listed |
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