The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Non-sterile, Power Free Nitrile Examination Gloves-orange, Green, Blue And Violet Color.
| Device ID | K143289 |
| 510k Number | K143289 |
| Device Name: | NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 1422-1424, BATU 10 LEKIR Sitiawan, Perak, MY 32020 |
| Contact | Arivagalan Subramaniam |
| Correspondent | Punitha Samy YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 1422-1424, BATU 10 LEKIR Sitiawan, Perak, MY 32020 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2015-08-18 |
| Summary: | summary |