The following data is part of a premarket notification filed by Spi Gloves Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves (blue,white,violet,pink,green,black).
| Device ID | K050528 |
| 510k Number | K050528 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) |
| Classification | Polymer Patient Examination Glove |
| Applicant | SPI GLOVES SDN. BHD. 5, PERSIARAN GREENTOWN 8 GREENTOWN BUSINESS CENTER Ipoh 30450, MY |
| Contact | Chooi Fong Chun |
| Correspondent | Chooi Fong Chun SPI GLOVES SDN. BHD. 5, PERSIARAN GREENTOWN 8 GREENTOWN BUSINESS CENTER Ipoh 30450, MY |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-05-19 |
| Summary: | summary |