The following data is part of a premarket notification filed by Top Quality Glove Sdn. Bhd with the FDA for Thermoplastic Polyethylene Examination (tpe) Glove.
| Device ID | K162626 |
| 510k Number | K162626 |
| Device Name: | THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | TOP QUALITY GLOVE SDN. BHD LOT 4961, JALAN TERATAI, BATU 6, OFF JALAN MERU Klang, MY 41050 |
| Contact | Hue Kon Fah |
| Correspondent | Hue Kon Fah TOP QUALITY GLOVE SDN. BHD LOT 4961, JALAN TERATAI, BATU 6, OFF JALAN MERU Klang, MY 41050 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2017-03-31 |