The following data is part of a premarket notification filed by Ivory Gloves Sdn. Bhd. with the FDA for Ivory Glove Powder-free Nitrile Examination Gloves.
| Device ID | K213681 |
| 510k Number | K213681 |
| Device Name: | Ivory Glove Powder-Free Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Ivory Gloves SDN. BHD. Lot 7806 Jalan Perusahaan 1, Kawasan Perindustrian Kamunting, MY 34600 |
| Contact | Arasi No Last Name Provided |
| 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 | 2021-11-22 |
| Decision Date | 2022-04-21 |