The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Non Sterile, Poweder Free Blue Nitrile Examination Gloves - 8623f.
| Device ID | K133123 |
| 510k Number | K133123 |
| Device Name: | NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F |
| Classification | Polymer Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. 14004 MANOR RD. PO BOX 445 Phonex, MD 21131 -0445 |
| Contact | Andrew Lowery |
| Correspondent | Andrew Lowery YTY INDUSTRY (MANJUNG) SDN. BHD. 14004 MANOR RD. PO BOX 445 Phonex, MD 21131 -0445 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-05-30 |