The following data is part of a premarket notification filed by Gmp Medicare Sdn Bhd (f25) with the FDA for Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange.
| Device ID | K172867 |
| 510k Number | K172867 |
| Device Name: | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange |
| Classification | Polymer Patient Examination Glove |
| Applicant | GMP MEDICARE SDN BHD (F25) LOT/PT64593, JLN Dahlia/KU8, KAW Perindustrian Meru Timur Klang, MY 41050 |
| Contact | Noraini Raus |
| Correspondent | Noraini Raus GMP MEDICARE SDN BHD (F25) LOT/PT64593, JLN Dahlia/KU8, KAW Perindustrian Meru Timur Klang, MY 41050 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-20 |
| Decision Date | 2018-05-10 |