The following data is part of a premarket notification filed by Pt. Maja Agung Latexindo with the FDA for Powder Free Nitrile Examination Gloves, Black.
| Device ID | K161099 |
| 510k Number | K161099 |
| Device Name: | Powder Free Nitrile Examination Gloves, Black |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. MAJA AGUNG LATEXINDO JALAN UTAMA NO. 98 PUJIMULYO Sunggal-deli Serdang, ID 20352 |
| Contact | Imelda Shamrock |
| Correspondent | Emmy Tjoeng SHAMROCK MANUFACTURING 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 | 2016-04-19 |
| Decision Date | 2017-02-23 |