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, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink.
| Device ID | K182382 |
| 510k Number | K182382 |
| Device Name: | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink |
| Classification | Patient Examination Glove, Specialty |
| Applicant | GMP Medicare SDN BHD (F25) Lot/PT64593, JLN Dahlia/KU8, Kaw Perindustrian Meru Timur Klang, MY 41050 |
| Contact | Noraini Bt Raus |
| Correspondent | Noraini Bt Raus GMP Medicare SDN BHD (F25) Lot/PT64593, JLN Dahlia/KU8, Kaw Perindustrian Meru Timur Klang, MY 41050 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-31 |
| Decision Date | 2019-08-29 |