The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Non-sterile, Powder Free Nitrile Examination Gloves (blue, Black And White Color).
| Device ID | K142283 |
| 510k Number | K142283 |
| Device Name: | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black And White Color) |
| Classification | Polymer Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 1422-1424, BATU 10 LEKIR Sitiawan, MY 32020 |
| Contact | Arivalagan Subramaniam |
| Correspondent | Andrew Lowery QA/GMP Consultant 14004 Manor Road PO Box 445 Phonex, MD 21131 -0045 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-15 |
| Decision Date | 2015-01-16 |
| Summary: | summary |