The following data is part of a premarket notification filed by Guthrie Medicare Products (melaka) Sdn Bhd with the FDA for Guthrie Shield Plus Blue Latex Examination Gloves (powder-free).
| Device ID | K010078 |
| 510k Number | K010078 |
| Device Name: | GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-10 |
| Decision Date | 2001-01-29 |