Innerwear, Gentlemen's Choice W/NONOXYNOL-9
FDA 510(k) K972429 · Custom Services Intl., Inc.
510(k) numberK972429
Submission
- Device name
- Innerwear, Gentlemen's Choice W/NONOXYNOL-9
- Applicant
- Custom Services Intl., Inc.
Las Vegas, NV, US - Received
- June 27, 1997
- Decision date
- September 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LTZ – Condom With Nonoxynol-9
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5310
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code LTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033163 | Caution CondomsLTZ · Traditional | Richard Van Haussen America, Inc. | 04/27/2004SE |
| K012969 | Double Springers Nonoxnol 9 CondomLTZ · Abbreviated | Medtech Products , Ltd. | 06/12/2002SE |
| K010178 | Spermicidal Lubricated Male Latex CondomLTZ · Abbreviated | Innolatex Sdn. Bhd | 04/27/2001SE |
| K003375 | Control Male Condoms of Natural Rubber LatexLTZ · Abbreviated | Tecnilatex S.A. | 01/28/2001SE |
| K001978 | 'One Touch' Latex Condom with NONOXYNOL-9LTZ · Abbreviated | Thai Nippon Rubber Industry Co., Ltd. | 08/08/2000SE |
| K001377 | Spermicidal Lubricated Male Latex CondomLTZ · Abbreviated | Pleasure Latex Products Sdn. Bhd. | 06/08/2000SE |
| K992438 | Invigra Plus (with Spermicidal Lubricant)LTZ · Abbreviated | Indus Medicare , Ltd. | 08/02/1999SE |
| K991047 | Hardcover Condoms Male Latex Condoms, (with Spermicide)LTZ · Abbreviated | Hardcover Products, Inc. | 06/18/1999SE |
| K990669 | Multiple-Brand Male Latex Condom (Lubricated with NONOXYNOL-9)LTZ · Abbreviated | Dongkuk Techco Rubber Industries Sdn. Bhd. | 05/17/1999SE |
| K981955 | Maxima, Trustex, Ria and Premium El Les CondomsLTZ · Traditional | Ls Rubber Sdn Bhd | 03/15/1999SE |
More from Ls Rubber Sdn Bhd
| 510(k) | Device | Decision |
|---|---|---|
| K972430 | Extrawear, Gentlemen's Choice W/NONOXYNOL-9LTZ · Traditional | 09/10/1997SE |
| K972428 | Extrawear, Gentlemen's ChoiceHIS · Traditional | 08/25/1997SE |
| K972427 | Innerwear, Jimmy-O Raincoat, Raincoat, Jasmine, DrinkHIS · Traditional | 08/20/1997SE |
| K970791 | Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/NaughtyLTZ · Traditional | 06/03/1997SE |
| K970767 | Condom (Rubber), Lubricated, Extra StrengthHIS · Traditional | 06/02/1997SE |
| K963322 | Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,TitanLTZ · Traditional | 01/22/1997SE |
| K963321 | Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,TitanHIS · Traditional | 01/22/1997SE |
| K963319 | Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodit,Zeus,Apollo,Selfcare,Careplus,TitanHIS · Traditional | 01/22/1997SE |
Questions and answers
When was Innerwear, Gentlemen's Choice W/NONOXYNOL-9 cleared by the FDA?
Innerwear, Gentlemen's Choice W/NONOXYNOL-9 (K972429) received a 510(k) decision of Substantially Equivalent on September 10, 1997, 75 days after the submission was received.
What is the product code of K972429?
The FDA product code is LTZ – Condom With Nonoxynol-9, a Class II (moderate risk) device regulated under 21 CFR 884.5310.