The following data is part of a premarket notification filed by Pentavest Holdings Sdn Bhd with the FDA for Penta Glove.
| Device ID | K212847 |
| 510k Number | K212847 |
| Device Name: | Penta Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Pentavest Holdings Sdn Bhd No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga, Batu, MY 76400 |
| Contact | Teng Boon Joo |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2022-01-06 |