The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Powdered Latex Medical Medical Examination Gloves With 150 Micrograms Or Less Of Total Water Extractable Protein Per Dm2.
| Device ID | K013443 |
| 510k Number | K013443 |
| Device Name: | POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 |
| Classification | Latex Patient Examination Glove |
| Applicant | MAXTER GLOVE MANUFACTURING SDN BHD LOT 607, JALAN HAJI ABDUL MANAN 41050 Klang, Selangor, MY 41050 |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai MAXTER GLOVE MANUFACTURING SDN BHD LOT 607, JALAN HAJI ABDUL MANAN 41050 Klang, Selangor, MY 41050 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-17 |
| Decision Date | 2001-11-29 |