The following data is part of a premarket notification filed by Gmp Medicare Sdn Bhd with the FDA for Nitrile Blue Powder Free Examination Gloves With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs.
| Device ID | K163017 |
| 510k Number | K163017 |
| Device Name: | Nitrile Blue Powder Free Examination Gloves With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | GMP MEDICARE SDN BHD LOT/PT64593, JLN DAHLIA/KU8, KAW PERINDUSTRIAN MERU TIMUR Klang, MY 41050 |
| Contact | Eva Vinoni Bt Mustafa |
| Correspondent | Eva Vinoni Bt Mustafa GMP MEDICARE SDN BHD 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 | 2016-10-28 |
| Decision Date | 2017-03-22 |