The following data is part of a premarket notification filed by Guthrie Medicare Products (melaka) Sdn Bhd with the FDA for Powderfree Nitrile Patient Exmination Glove.
| Device ID | K003985 |
| 510k Number | K003985 |
| Device Name: | POWDERFREE NITRILE PATIENT EXMINATION GLOVE |
| Classification | Polymer 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850039389139 | K003985 | 000 |
| 00850039389115 | K003985 | 000 |
| 00850039389085 | K003985 | 000 |
| 00850039389054 | K003985 | 000 |
| 00850039389030 | K003985 | 000 |