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 |