The following data is part of a premarket notification filed by Great Eco Glove Sdn. Bhd. with the FDA for Nitrile Examination Gloves Powder Free (blue).
| Device ID | K210868 |
| 510k Number | K210868 |
| Device Name: | Nitrile Examination Gloves Powder Free (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Great Eco Glove Sdn. Bhd. Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya, MY 45600 |
| Contact | Soh Wei Li |
| Correspondent | Shahnaz Sakinah Great Eco Glove Sdn. Bhd. Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya, MY 45600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2021-09-02 |