The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Polymer Coated Powder Free Latex Medical Examination Gloves With Protein Labeling Claim (50 Micrograms Or Less).
| Device ID | K013554 |
| 510k Number | K013554 |
| Device Name: | POLYMER COATED 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 | 2001-10-25 |
| Decision Date | 2002-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479188295 | K013554 | 000 |
| 00612479188235 | K013554 | 000 |
| 00612479188259 | K013554 | 000 |
| 00612479188273 | K013554 | 000 |
| 00612479188297 | K013554 | 000 |
| 40612479188219 | K013554 | 000 |
| 40612479188233 | K013554 | 000 |
| 40612479188257 | K013554 | 000 |
| 40612479188271 | K013554 | 000 |
| 00612479188211 | K013554 | 000 |