The following data is part of a premarket notification filed by Comfort Rubber Gloves Ind. Sdn. Bhd. with the FDA for Powder Free Nitrile (blue And White) Examination Gloves.
| Device ID | K083624 |
| 510k Number | K083624 |
| Device Name: | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | COMFORT RUBBER GLOVES IND. SDN. BHD. LOT 821, JALAN MATANG 34750 MATANG Taiping, Perak, MY |
| Contact | Tan K Beng |
| Correspondent | Tan K Beng COMFORT RUBBER GLOVES IND. SDN. BHD. LOT 821, JALAN MATANG 34750 MATANG Taiping, Perak, MY |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-02-10 |