The following data is part of a premarket notification filed by Rimba Glove Snd Bhd with the FDA for Blue Nitrile Powder Free Patient Examination Glove, Non-sterile, Tested For Use With Chemotherapy Drugs.
Device ID | K212898 |
510k Number | K212898 |
Device Name: | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs |
Classification | Polymer Patient Examination Glove |
Applicant | Rimba Glove SND BHD Plot 37, Medan Tasek, Tasek Industrial Area, Ipoh, MY 31400 |
Contact | Zahari Bin Darus |
Correspondent | Michael Van Der Woude Emergo Global Representation LLC 2500 Bee Cave Road Bldg 1, Suite 300 Austin, TX 78746 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-10 |
Decision Date | 2021-12-16 |