Top Glove Medical (Thailand) Co., Ltd. · Class I · Cleared Feb 10, 2023
| K-number | K222129 |
| Device name | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim |
| Applicant | Top Glove Medical (Thailand) Co., Ltd. |
| Product code | LZA |
| Device class | Class I |
| Decision date | Feb 10, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov