The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Chlorinated Powder Free Latex Medical Examination Gloves With Protein Labeling Claim (50 Micrograms Or Less).
| Device ID | K013498 |
| 510k Number | K013498 |
| Device Name: | CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | MAXTER GLOVE MANUFACTURING SDN BHD 6TH MILES OFF JALAN MERU Klang Selangor, MY 41050 |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai MAXTER GLOVE MANUFACTURING SDN BHD 6TH MILES OFF JALAN MERU 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 | 2001-10-22 |
| Decision Date | 2002-01-17 |