The following data is part of a premarket notification filed by Gmp Medicare Sdn Bhd with the FDA for Nitrile Powder Free Examination Glove, Blue Tested For Use With 32 Chemotherapy Drugs And Fentanyl Permeation Resistance Claim.
| Device ID | K202003 |
| 510k Number | K202003 |
| Device Name: | Nitrile Powder Free Examination Glove, Blue Tested For Use With 32 Chemotherapy Drugs And Fentanyl Permeation Resistance Claim |
| Classification | Polymer Patient Examination Glove |
| Applicant | GMP Medicare SDN BHD Lot/PT 64593, Jalan Dahlia/KU8, Kawasan Perindustrian Meru Timur, Klang, MY 41050 |
| Contact | Noraini Binti |
| Correspondent | David Lim TG Medical USA (INC) 165 N. Aspen Avenue Azusa, CA 91702 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-20 |
| Decision Date | 2021-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860008768244 | K202003 | 000 |
| 10860008768237 | K202003 | 000 |
| 10860008768206 | K202003 | 000 |