The following data is part of a premarket notification filed by Top Calibre Sdn Bhd with the FDA for Powder Free Nitrile Patient Examination Glove,blue And Orange Colored,non-sterile Tested For Use With Chemotherapy Drugs.
| Device ID | K133949 |
| 510k Number | K133949 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Classification | Polymer Patient Examination Glove |
| Applicant | TOP CALIBRE SDN BHD Lot 13726, Jalan Haji Salleh, Batu 5 1/4 Off Jalan Meru Klang, Selangor, MY 41050 |
| Contact | Rosnita Maodin |
| Correspondent | Rosnita Maodin TOP CALIBRE SDN BHD Lot 13726, Jalan Haji Salleh, Batu 5 1/4 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 | 2013-12-23 |
| Decision Date | 2014-04-08 |
| Summary: | summary |