The following data is part of a premarket notification filed by Encompass Industries Sdn. Bhd. with the FDA for Powder-free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl (white, Blue, Black, Orange And Green Color).
| Device ID | K220609 |
| 510k Number | K220609 |
| Device Name: | Powder-Free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl (White, Blue, Black, Orange And Green Color) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q Kertih BioPolymer Park Kemaman, MY 24300 |
| Contact | Nur Atikah Binti Muhammad Muhyiddin |
| Correspondent | Nur Atikah Binti Muhammad Muhyiddin Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q Kertih BioPolymer Park Kemaman, MY 24300 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-05-27 |