The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Non-sterile, Powder-free Black Nitrile Examination Gloves.
| Device ID | K061553 |
| 510k Number | K061553 |
| Device Name: | NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-05 |
| Decision Date | 2006-07-17 |
| Summary: | summary |