The following data is part of a premarket notification filed by Pt. Universal Gloves with the FDA for Disposable Nitrile Powder Free Examination Gloves (non-sterile).
| Device ID | K211360 |
| 510k Number | K211360 |
| Device Name: | Disposable Nitrile Powder Free Examination Gloves (Non-sterile) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Pt. Universal Gloves Jl. Patumbak No.17 Patumbak Medan, ID 20361 |
| Contact | Sutopo Sutopo |
| Correspondent | Sasitharan Nair Ammex Corporation 1019 W James St #200 Kent, WA 98032 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-01-15 |