The following data is part of a premarket notification filed by Spi Gloves Sdn. Bhd. with the FDA for Powdered Latex Examination Gloves With Protein Labeling Claim (contains 200 Micrograms Or Less Of Total Water Extractabl.
| Device ID | K050527 |
| 510k Number | K050527 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL |
| 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 | 2005-03-18 |
| Summary: | summary |