The following data is part of a premarket notification filed by Biopro (m) Sdn Bhd with the FDA for Correct Touch Latex Powdered Examination Gloves.
| Device ID | K994043 |
| 510k Number | K994043 |
| Device Name: | CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | BIOPRO (M) SDN BHD LOT14, PT.4204 LINGKARN SULTN HISHAMUDDIN, NO. PRT. INDU. Port Klang, MY 42000 |
| Contact | James H Lale |
| Correspondent | James H Lale BIOPRO (M) SDN BHD LOT14, PT.4204 LINGKARN SULTN HISHAMUDDIN, NO. PRT. INDU. Port Klang, MY 42000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-29 |
| Decision Date | 2000-01-11 |