The following data is part of a premarket notification filed by Top Glove Sdn Bhd with the FDA for Latex Examination Powder Free Glove, Aloe Vera.
| Device ID | K193150 |
| 510k Number | K193150 |
| Device Name: | Latex Examination Powder Free Glove, Aloe Vera |
| Classification | Polymer Patient Examination Glove |
| Applicant | Top Glove SDN BHD Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru Klang, MY 41050 |
| Contact | Noor Akilah Bt Saidin |
| Correspondent | David Lim TG Medical (USA) Inc 165, North Aspan Avenue Azusa, CA 91702 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2020-06-05 |