Hartalega Sdn Bhd · Class I · Cleared Sep 4, 2009
| K-number | K091652 |
| Device name | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS |
| Applicant | Hartalega Sdn Bhd |
| Product code | LZA |
| Device class | Class I |
| Decision date | Sep 4, 2009 |
| 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