The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs.
| Device ID | K122999 |
| 510k Number | K122999 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Classification | Polymer Patient Examination Glove |
| Applicant | TOP GLOVE SDN. BHD. LOT 4968, BATU 6,JALAN TERATAI OFF JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Eddy Rosaydie |
| Correspondent | Eddy Rosaydie TOP GLOVE SDN. BHD. LOT 4968, BATU 6,JALAN TERATAI OFF JALAN MERU Klang, Selangor, 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 | 2012-09-27 |
| Decision Date | 2012-11-30 |