Magnum Plus Latex Condoms with Spermicidal Lub.
FDA 510(k) K904273 · Carter Products
510(k) numberK904273
Submission
- Device name
- Magnum Plus Latex Condoms with Spermicidal Lub.
- Applicant
- Carter Products
Cranbury, NJ, US - Received
- September 17, 1990
- Decision date
- October 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K955672 | Trojan Polyurethane Condom (Modification)MOL · Traditional | 08/29/1996SE |
| K942697 | Trojan Polyurethane CondomMOL · Traditional | 06/22/1995SE |
| K912901 | Trojan (Tm-Tbd) CondomHIS · Traditional | 02/03/1992SE |
| K904782 | Answer Quick and Simple At-Home Pregnancy TestLCX · Traditional | 12/06/1990SE |
| K901202 | Trojan Naturalamb Lubricated Natural ModifiedHIS · Traditional | 06/19/1990SE |
| K901201 | Trojan Ribbed Latex Condoms W/Sperm. ModifiedHIS · Traditional | 04/16/1990SE |
| K901200 | Trojan for Women Latex Condoms W/Spermi. ModifiedHIS · Traditional | 04/16/1990SE |
| K901199 | Trojan-Enz Latex Condoms W/Spermicidal ModifiedHIS · Traditional | 04/16/1990SE |
| K901198 | Trojan Plus 2 Latex Condoms W/Spermicidal ModifiedHIS · Traditional | 04/16/1990SE |
| K901197 | Trojan Extra Strength Lubri. Condoms Modi. LabelHIS · Traditional | 04/16/1990SE |
Questions and answers
When was Magnum Plus Latex Condoms with Spermicidal Lub. cleared by the FDA?
Magnum Plus Latex Condoms with Spermicidal Lub. (K904273) received a 510(k) decision of Substantially Equivalent on October 31, 1990, 44 days after the submission was received.
What is the product code of K904273?
The FDA product code is LTZ – Condom With Nonoxynol-9, a Class II (moderate risk) device regulated under 21 CFR 884.5310.