The following data is part of a premarket notification filed by Mah Sing Healthcare Sdn Bhd with the FDA for Nitrile Powder Free Blue Examination Gloves, Non-sterile.
| Device ID | K212535 |
| 510k Number | K212535 |
| Device Name: | Nitrile Powder Free Blue Examination Gloves, Non-Sterile |
| Classification | Polymer Patient Examination Glove |
| Applicant | Mah Sing Healthcare Sdn Bhd Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, MY 57100 |
| Contact | Azlan Hashim |
| Correspondent | Azlan Hashim Mah Sing Healthcare Sdn Bhd Wisma Mah Sing, Penthouse Suite 1, 163 Jalan Sungai Besi Kuala Lumpur, MY 57100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2021-12-04 |