The following data is part of a premarket notification filed by Sri Johani Sdn. Bhd. with the FDA for High Risk Powderfree Latex Examination Gloves (blue Colour).
| Device ID | K973801 |
| 510k Number | K973801 |
| Device Name: | HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) |
| Classification | Latex Patient Examination Glove |
| Applicant | SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor, MY 43300 |
| Contact | Lim L Aik |
| Correspondent | Lim L Aik SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor, MY 43300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1997-11-21 |