The following data is part of a premarket notification filed by One Glove Industrial Sdn Bhd with the FDA for Violet Nitrile Powder-free Patient Examination Glove, Non Sterile.
| Device ID | K220429 |
| 510k Number | K220429 |
| Device Name: | Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile |
| Classification | Polymer Patient Examination Glove |
| Applicant | One Glove Industrial SDN BHD 24, 1st Floor, Kompleks Kota Mulia, Jalan Long Jaafar, Taiping, MY 34000 |
| Contact | Marcus Low |
| Correspondent | Michael Van Der Woude Emergo Global Representative LLC, 2500 Bee Cave Road, Building 1 Suite 300, Austin, TX 78746 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-15 |
| Decision Date | 2022-05-13 |