The following data is part of a premarket notification filed by Guthrie Medicare Products (melaka) Sdn Bhd with the FDA for Guthrie Powderfree Latex Examination Gloves.
| Device ID | K954967 |
| 510k Number | K954967 |
| Device Name: | GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 7400 NORTH ORACLE SUITE 330 Tucson, AZ 85704 |
| Contact | Kathy Salfingere |
| Correspondent | Kathy Salfingere GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD 7400 NORTH ORACLE SUITE 330 Tucson, AZ 85704 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-04-15 |