The following data is part of a premarket notification filed by Pt. Universal Gloves with the FDA for Disposable Latex Examination Gloves (non-sterile), Disposable Nitrile Examination Gloves (non-sterile).
| Device ID | K203074 |
| 510k Number | K203074 |
| Device Name: | Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. Universal Gloves Jl. Pertahanan No. 17 Patumbak Medan, ID 20361 |
| Contact | Li I-feng |
| Correspondent | I-feng Li PT. Universal Gloves Jl. Pertahanan No. 17 Patumbak Medan, ID 20361 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-09 |
| Decision Date | 2021-11-19 |