The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Gloves (blue), Nitrile Powder Free Examination Gloves (pink).
| Device ID | K071910 |
| 510k Number | K071910 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD # 7, KAWASAN PERUSAHAAN SURIA BATANG BERJUNTAI Selangor, Darul Ehsan, MY 45600 |
| Contact | Nurul Aisyah Kong Bt Abdullah |
| Correspondent | Nurul Aisyah Kong Bt Abdullah HARTALEGA SDN BHD # 7, KAWASAN PERUSAHAAN SURIA BATANG BERJUNTAI Selangor, Darul Ehsan, MY 45600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-11 |
| Decision Date | 2007-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009069947 | K071910 | 000 |
| 00860009074590 | K071910 | 000 |
| 00860009074538 | K071910 | 000 |
| 00860009074545 | K071910 | 000 |
| 00860009074552 | K071910 | 000 |
| 00860009074569 | K071910 | 000 |
| 00860009074576 | K071910 | 000 |
| 00860009074583 | K071910 | 000 |
| 00860009069992 | K071910 | 000 |
| 00860009069909 | K071910 | 000 |
| 00860009069916 | K071910 | 000 |
| 00860009074507 | K071910 | 000 |
| 00860009069985 | K071910 | 000 |
| 00860010239049 | K071910 | 000 |