The following data is part of a premarket notification filed by Guthrie Medicare Products (melaka) Sdn Bhd with the FDA for Patient Examination Latex Gloves (non-sterile).
| Device ID | K911694 |
| 510k Number | K911694 |
| Device Name: | PATIENT EXAMINATION LATEX GLOVES (NON-STERILE) |
| Classification | Latex Patient Examination Glove |
| Applicant | GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD LOT 179-184 KAW., ALOR GAJAH INDUSTRIAL ESTATE, (PHASE III) Kelemak, Alor Gajah, Melaka, MY 78000 |
| Contact | Yang |
| Correspondent | Yang GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD LOT 179-184 KAW., ALOR GAJAH INDUSTRIAL ESTATE, (PHASE III) Kelemak, Alor Gajah, Melaka, MY 78000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-16 |
| Decision Date | 1991-04-25 |