Spermicidal Lubricated Male Latex Condom
FDA 510(k) K001377 · Pleasure Latex Products Sdn. Bhd.
510(k) numberK001377
Submission
- Device name
- Spermicidal Lubricated Male Latex Condom
- Applicant
- Pleasure Latex Products Sdn. Bhd.
Jeram, Selangor Darul Ehsan, MY - Received
- May 1, 2000
- Decision date
- June 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K981621 | Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted ColorsLTZ · Traditional | Suretex Prophylactics (India) , Ltd. | 06/19/1998SE |
More from Suretex Prophylactics (India) , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K022156 | Latex Ultrasonic Probe CoverITX · Abbreviated | 09/11/2003SE |
| K023333 | Multiple, Male Latex Condom [52MM or 56MM Nominal Width with Smooth or Dotted or Ribbed…HIS · Abbreviated | 06/23/2003SE |
| K021875 | Male Latex Condom with Dotted/Ribbed Surface and Counour-Walled Shape (3 in 1 Ultimate…HIS · Abbreviated | 09/05/2002SE |
| K020272 | Male Latex Condom with Ribbed SurfaceHIS · Abbreviated | 04/26/2002SE |
| K002571 | Mulitple Male Latx CondomHIS · Abbreviated | 11/16/2000SE |
| K001221 | Male Latex Comdom with Dotted SurfaceHIS · Abbreviated | 05/19/2000SE |
| K994312 | Male Latex Condom 56MMHIS · Abbreviated | 03/21/2000SE |
| K994311 | Male Latex Condom with Vanilla FlavorHIS · Abbreviated | 03/21/2000SE |
| K982380 | SureHIS · Traditional | 02/26/1999SE |
Questions and answers
When was Spermicidal Lubricated Male Latex Condom cleared by the FDA?
Spermicidal Lubricated Male Latex Condom (K001377) received a 510(k) decision of Substantially Equivalent on June 8, 2000, 38 days after the submission was received.
What is the product code of K001377?
The FDA product code is LTZ – Condom With Nonoxynol-9, a Class II (moderate risk) device regulated under 21 CFR 884.5310.