The following data is part of a premarket notification filed by Emerald Glove Manufacturing Sdn Bhd with the FDA for Nitrile Examination Gloves.
| Device ID | K213981 |
| 510k Number | K213981 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Emerald Glove Manufacturing Sdn Bhd Lot 18912 & Lot 18911, Jalan Perusahaan 8, Kawasan Perindustrian Kamunting Taiping, MY 834600 |
| Contact | Amran A. Aziz |
| Correspondent | Lim Pooi Yee Novo Quality Services Sdn Bhd Unit No 625 & 627, Block A, Kelana Centre Point, 3, Jalan SS7/19, Kelana Jaya Petaling Jaya, MY 47301 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-11-12 |