The following data is part of a premarket notification filed by Tec Gloves Industry (m) Sdn.bhd. with the FDA for Nitrile Powder Free Blue Patient Examination Gloves, Non-sterile.
| Device ID | K221378 |
| 510k Number | K221378 |
| Device Name: | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile |
| Classification | Polymer Patient Examination Glove |
| Applicant | Tec Gloves Industry (M) Sdn.Bhd. Lot 35793, Jalan Sungai Batu 31/KU6, Kawasan Perindustrian Klang Utama Klang, MY 42100 |
| Contact | Eunice Arumugam |
| Correspondent | Eunice Arumugam Tec Gloves Industry (M) Sdn.Bhd. Lot 35793, Jalan Sungai Batu 31/KU6, Kawasan Perindustrian Klang Utama Klang, MY 42100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-12 |
| Decision Date | 2022-09-30 |