The following data is part of a premarket notification filed by Pt. Universal Gloves with the FDA for Disposable Latex Powder Free Examination Gloves (non-sterile).
| Device ID | K201576 |
| 510k Number | K201576 |
| Device Name: | Disposable Latex Powder Free Examination Gloves (Non-sterile) |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. Universal Gloves JL. Pertahanan No.17 Patumbak Medan, ID 20361 |
| Contact | Sutopo Sutopo |
| Correspondent | Sasitharan Nair Ammex Corporation 1019 W James St #200, 98032, United States Kent, WA 98032 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2021-05-19 |