The following data is part of a premarket notification filed by Avecena Gloves Sdn Bhd with the FDA for Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves.
| Device ID | K213775 |
| 510k Number | K213775 |
| Device Name: | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves |
| Classification | Latex Patient Examination Glove |
| Applicant | Avecena Gloves Sdn Bhd Lot 50592 Sendayan Techvalley Bandar Sri Sendayan Seremban Negeri Sembilan, MY 71950 |
| Contact | Mohd Aswad Bin Ramli |
| Correspondent | Mehmet Fatih Ormeci MEDCER Uluslararasi Medikal Belgelendirme Anonim Sirketi Mevlana Bulvari No:221/141 Yildirim Kule Ankara, TR 06830 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-02 |
| Decision Date | 2022-04-24 |