The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn Bhd with the FDA for Patient Examination Gloves.
| Device ID | K935256 |
| 510k Number | K935256 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak Darul Ridzuan, MY 34750 |
| Contact | Chee Yong Foo |
| Correspondent | Chee Yong Foo 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 | 1993-11-01 |
| Decision Date | 1994-03-09 |