The following data is part of a premarket notification filed by Ideal Quality Sdn., Bhd. with the FDA for Powder-free Latex Examination Glove.
| Device ID | K974662 |
| 510k Number | K974662 |
| Device Name: | POWDER-FREE LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | IDEAL QUALITY SDN., BHD. JALAN SUNGAI SEMBILANG 45800 JERAM Selangor Darul Eshan, MY |
| Contact | Lim L Bung |
| Correspondent | Lim L Bung IDEAL QUALITY SDN., BHD. JALAN SUNGAI SEMBILANG 45800 JERAM Selangor Darul Eshan, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-04-02 |