The following data is part of a premarket notification filed by Pt. Maja Agung Latexindo with the FDA for Powder Free Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs Use And Simulated Gastric Acid).
| Device ID | K212408 |
| 510k Number | K212408 |
| Device Name: | Powder Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs Use And Simulated Gastric Acid) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Pt. Maja Agung Latexindo Jl. Utama No. 98, Pujimulyo Sunggal, Deli Serdang, ID 20352 |
| Contact | Sivaprakash S |
| Correspondent | Jeni Chuason Shamrock Marketing Co., Inc. 5445 Daniels Street Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-03 |
| Decision Date | 2022-05-18 |