The following data is part of a premarket notification filed by Emerald Glove Manufacturing Sdn Bhd with the FDA for Nitrile Examination Gloves.
Device ID | K213981 |
510k Number | K213981 |
Device Name: | Nitrile Examination Gloves |
Classification | Polymer Patient Examination Glove |
Applicant | Emerald Glove Manufacturing Sdn Bhd Lot 18912 & Lot 18911, Jalan Perusahaan 8, Kawasan Perindustrian Kamunting Taiping, MY 834600 |
Contact | Amran A. Aziz |
Correspondent | Lim Pooi Yee Novo Quality Services Sdn Bhd Unit No 625 & 627, Block A, Kelana Centre Point, 3, Jalan SS7/19, Kelana Jaya Petaling Jaya, MY 47301 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-12-20 |
Decision Date | 2022-11-12 |