The following data is part of a premarket notification filed by Wuhrlin Soplamed (m) Sdn Bhd with the FDA for Patient Examination Gloves.
| Device ID | K924386 |
| 510k Number | K924386 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | WUHRLIN SOPLAMED (M) SDN BHD LOT 1,LEBOH HISHAMUDDINB SATU N. KLANG STRAITS INDU. AREA 42000 Port Klang,selangor, MY |
| Contact | Chin Woo |
| Correspondent | Chin Woo WUHRLIN SOPLAMED (M) SDN BHD LOT 1,LEBOH HISHAMUDDINB SATU N. KLANG STRAITS INDU. AREA 42000 Port Klang,selangor, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1993-07-13 |