SPERMICIDAL LUBRICATED MALE LATEX CONDOM— 510(k) K001377
Substantially EquivalentPleasure Latex Products Sdn. Bhd.
FDA 510(k) clearance K001377 for SPERMICIDAL LUBRICATED MALE LATEX CONDOM, Substantially Equivalent on 2000-06-08. Applicant: Pleasure Latex Products Sdn. Bhd.. Device class: 2.
Clearance details
- Applicant
- Pleasure Latex Products Sdn. Bhd.
- Product code
- Code LTZ
- Device class
- Class 2
- Regulation
- 21 CFR 884.5310
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Jeram, Selangor Darul Ehsan, MY
Recent devices under product code LTZ
view allMore clearances from Pleasure Latex Products Sdn. Bhd.
view all- K022156 — LATEX ULTRASONIC PROBE COVER
- K023333 — MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
- K021875 — MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
- K020272 — MALE LATEX CONDOM WITH RIBBED SURFACE
- K002571 — MULITPLE MALE LATX CONDOM
Data sourced from openFDA. This site is unofficial and independent of the FDA.