The following data is part of a premarket notification filed by Encompass Medical Supplies Onc Limited with the FDA for Powder Free Nitrile Examination Glove, Blue Colored, Black Colored And White Colored.
| Device ID | K120184 |
| 510k Number | K120184 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED |
| Classification | Polymer Patient Examination Glove |
| Applicant | ENCOMPASS MEDICAL SUPPLIES ONC LIMITED HUA SHEN ROAD WAI GAO QIAO FREE ZONE Shanghai, CN 200131 |
| Contact | Cj Ang |
| Correspondent | Cj Ang ENCOMPASS MEDICAL SUPPLIES ONC LIMITED HUA SHEN ROAD WAI GAO QIAO FREE ZONE Shanghai, CN 200131 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-05-02 |
| Summary: | summary |