The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Non-sterile, Powder-free, Polymer Coated, Natural And/or Violet And Black Color, Latex Examination Gloves With Protein.
| Device ID | K030164 |
| 510k Number | K030164 |
| Device Name: | NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN |
| 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 | 2003-01-16 |
| Decision Date | 2003-03-07 |
| Summary: | summary |