The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn Bhd with the FDA for Powder Free Nitrile (black) Examination Gloves.
| Device ID | K110297 |
| 510k Number | K110297 |
| Device Name: | POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak, MY 34750 |
| Contact | Tan Keng Beng |
| Correspondent | Tan Keng Beng COMFORT RUBBER GLOVES INDUSTRIES SDN BHD LOT 821, JALAN MATANG Taiping, Perak, MY 34750 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-01 |
| Decision Date | 2011-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10699320422868 | K110297 | 000 |
| 10699320422851 | K110297 | 000 |
| 10699320422844 | K110297 | 000 |
| 10699320422837 | K110297 | 000 |
| 10699320422820 | K110297 | 000 |