The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (white); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (blue).
| Device ID | K162405 |
| 510k Number | K162405 |
| Device Name: | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Matang, MY 84750 |
| Contact | Chan Yew Men |
| Correspondent | Chan Yew Men COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Matang, MY 84750 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-29 |
| Decision Date | 2017-03-28 |
| Summary: | summary |