The following data is part of a premarket notification filed by Gmp Medicare Sdn Bhd (f25) with the FDA for Nitrile Blue Powder Free Examination Gloves Tested For Use With Chemotheraphy Drugs.
| Device ID | K152222 |
| 510k Number | K152222 |
| Device Name: | NITRILE BLUE POWDER FREE EXAMINATION GLOVES Tested For Use With Chemotheraphy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | GMP MEDICARE SDN BHD (F25) LOT/PT64593,JLN DAHLIA/KU8,KAW PERINDUSTRIAN MERU TIMUR Klang, MY 41050 |
| Contact | Ms.eva Vinoni Mustafa |
| Correspondent | Ms.eva Vinoni Mustafa 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 | 2015-08-07 |
| Decision Date | 2016-04-21 |