The following data is part of a premarket notification filed by Sri Johani Sdn. Bhd. with the FDA for Polymer Nitrile Examination Gloves (blue Colour).
| Device ID | K974183 |
| 510k Number | K974183 |
| Device Name: | POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor, MY 43300 |
| Contact | Lim Lee Aik |
| Correspondent | Lim Lee Aik SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor, MY 43300 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-06 |
| Decision Date | 1997-12-18 |