The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn Bhd with the FDA for Comfort Rubber Gloves Ind.sdn.bhd..
| Device ID | K101917 |
| 510k Number | K101917 |
| Device Name: | COMFORT RUBBER GLOVES IND.SDN.BHD. |
| Classification | Latex Patient Examination Glove |
| Applicant | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan, MY 34750 |
| Contact | Tan Keng Beng |
| Correspondent | Tan Keng Beng COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan, MY 34750 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-09 |
| Decision Date | 2010-10-29 |
| Summary: | summary |