The following data is part of a premarket notification filed by Multisafe Sdn. Bhd. with the FDA for Nitrile Patient Examination Powder Free Glove, Textured, Black.
| Device ID | K161085 |
| 510k Number | K161085 |
| Device Name: | Nitrile Patient Examination Powder Free Glove, Textured, Black |
| Classification | Polymer Patient Examination Glove |
| Applicant | MULTISAFE SDN. BHD. LOT 764, BIDOR INDUSTRIAL ESTATE Bidor, MY 35500 |
| Contact | Thum Teck Lam |
| Correspondent | Rosnani Hassan Besari MULTISAFE SDN. BHD. LOT 764, BIDOR INDUSTRIAL ESTATE Bidor, MY 35500 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2018-07-05 |