The following data is part of a premarket notification filed by Biopro (m) Sdn Bhd with the FDA for Biopro, Nitrilon, Correct Touch- Nitrile Powdered Examination Gloves (green/ Purple).
| Device ID | K994276 |
| 510k Number | K994276 |
| Device Name: | BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-10-20 |