The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K113100 |
| 510k Number | K113100 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Classification | Polymer Patient Examination Glove |
| Applicant | MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, MY 41050 |
| Contact | Yap P Geeh |
| Correspondent | Yap P Geeh MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, MY 41050 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2012-02-06 |