The following data is part of a premarket notification filed by Biopro (m) Sdn Bhd with the FDA for Nitrilon Correct-touch.
| Device ID | K981333 |
| 510k Number | K981333 |
| Device Name: | NITRILON CORRECT-TOUCH |
| Classification | Polymer Patient Examination Glove |
| Applicant | BIOPRO (M) SDN BHD 4349 SANTA FE RD. San Luis Obispo, CA 93401 |
| Contact | Mike Kyle |
| Correspondent | Mike Kyle BIOPRO (M) SDN BHD 4349 SANTA FE RD. San Luis Obispo, CA 93401 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-06-22 |