Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors
FDA 510(k) K972836 · G. Premjee (Usa), Inc.
510(k) numberK972836
Submission
- Device name
- Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors
- Applicant
- G. Premjee (Usa), Inc.
Great Neck, NY, US - Received
- July 31, 1997
- Decision date
- October 22, 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 |
|---|---|---|
| K971132 | Royale Brand Latex Condoms (Silicone)-Colored/Assorted ColorsHIS · Traditional | 09/03/1997SE |
Questions and answers
When was Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors cleared by the FDA?
Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors (K972836) received a 510(k) decision of Substantially Equivalent on October 22, 1997, 83 days after the submission was received.
What is the product code of K972836?
The FDA product code is LTZ – Condom With Nonoxynol-9, a Class II (moderate risk) device regulated under 21 CFR 884.5310.