The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Evergreen Non-sterile Powder-free, Colored Nitrile Examination Gloves.
| Device ID | K990013 |
| 510k Number | K990013 |
| Device Name: | EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. PO BOX 4341 Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith YTY INDUSTRY (MANJUNG) SDN. BHD. PO BOX 4341 Crofton, MD 21114 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-04 |
| Decision Date | 1999-03-23 |