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, Tested For Use With Chemotherapy Drugs (blue, Cobalt Blue).
| Device ID | K171104 |
| 510k Number | K171104 |
| Device Name: | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue, Cobalt Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN BHD Lot 1422-1424, Batu 10 Lekir Sitiawan, MY 32020 |
| Contact | Punitha Samy |
| Correspondent | Punitha Samy YTY INDUSTRY (MANJUNG) SDN BHD Lot 1422-1424, Batu 10 Lekir Sitiawan, 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 | 2017-04-13 |
| Decision Date | 2017-08-25 |
| Summary: | summary |