The following data is part of a premarket notification filed by Guthrie Medicare Products (melaka) Sdn Bhd with the FDA for Guthrie Latex Surgical Glove (pre-powdered).
| Device ID | K001047 |
| 510k Number | K001047 |
| Device Name: | GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-31 |
| Decision Date | 2000-04-28 |