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 |