The following data is part of a premarket notification filed by Spi Gloves Sdn. Bhd. with the FDA for Polymer Coated Powder Free Latex Examination Gloves With Protein Labeling Claim (contains 50 Micrograms Or Less Of Toter.
| Device ID | K050529 |
| 510k Number | K050529 |
| Device Name: | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER |
| Classification | Latex 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 | LYY |
| 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 | 2005-03-16 |
| Summary: | summary |