The following data is part of a premarket notification filed by New Era Medicare Sdn. Bhd. with the FDA for Non Sterile Powder Free Latex Examination Glove.
| Device ID | K221667 |
| 510k Number | K221667 |
| Device Name: | Non Sterile Powder Free Latex Examination Glove |
| Classification | Latex Patient Examination Glove |
| Applicant | New Era Medicare Sdn. Bhd. Plot 2621-2624 Teluk Intan, MY 36000 |
| Contact | Fatin Nor Irdina Binti Ahmad Fauzi |
| Correspondent | Fatin Nor Irdina Binti Ahmad Fauzi New Era Medicare Sdn. Bhd. Plot 2621-2624 Teluk Intan, MY 36000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-08 |
| Decision Date | 2022-10-28 |