The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Powdered Natural And/or Colored Latex Exam Gloves.
| Device ID | K023590 |
| 510k Number | K023590 |
| Device Name: | POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker YTY INDUSTRY (MANJUNG) SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-25 |
| Decision Date | 2002-11-08 |
| Summary: | summary |