The following data is part of a premarket notification filed by Biopro (m) Sdn Bhd with the FDA for Biopro, Nitrile, Correct Touch Nitrile Powder Free Examination Gloves (grren, Purple).
| Device ID | K994281 |
| 510k Number | K994281 |
| Device Name: | BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036000434481 | K994281 | 000 |
| 10036000434382 | K994281 | 000 |
| 10036000434399 | K994281 | 000 |
| 10036000434405 | K994281 | 000 |
| 10036000434412 | K994281 | 000 |
| 10036000434436 | K994281 | 000 |
| 10036000434443 | K994281 | 000 |
| 10036000434450 | K994281 | 000 |
| 10036000434467 | K994281 | 000 |
| 10036000434474 | K994281 | 000 |
| 10036000434375 | K994281 | 000 |