Wrp Asia Pacific Sdn. Bhd. · Class I · Cleared Aug 31, 2023
| K-number | K230578 |
| Device name | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl |
| Applicant | Wrp Asia Pacific Sdn. Bhd. |
| Product code | KGO |
| Device class | Class I |
| Decision date | Aug 31, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 878.4460 |
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