The following data is part of a premarket notification filed by Koon Seng Sdn.bhd with the FDA for Royal Imperial Nitrile Examination Gloves Textured Powder-free.
| Device ID | K110960 |
| 510k Number | K110960 |
| Device Name: | ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | KOON SENG SDN.BHD 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls KOON SENG SDN.BHD 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-05 |
| Decision Date | 2011-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885380135086 | K110960 | 000 |
| D79010673023 | K110960 | 000 |
| D79010673033 | K110960 | 000 |
| D79010673043 | K110960 | 000 |
| D79010673053 | K110960 | 000 |
| 00612479188310 | K110960 | 000 |
| 00612479188334 | K110960 | 000 |
| 00612479188358 | K110960 | 000 |
| 00612479188372 | K110960 | 000 |
| 50885380135062 | K110960 | 000 |
| 50885380135079 | K110960 | 000 |
| 50885380135093 | K110960 | 000 |
| 50885380135109 | K110960 | 000 |
| 50885380137165 | K110960 | 000 |
| D79010673013 | K110960 | 000 |