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 |