The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Supergloves Sterile Powdered Latex Examination Gloves.
| Device ID | K000644 |
| 510k Number | K000644 |
| Device Name: | SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SUPERMAX GLOVE MANUFACTURING SDN BHD 47000 SUNGAI BULOH Selangor, MY |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX GLOVE MANUFACTURING SDN BHD 47000 SUNGAI BULOH Selangor, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-03-17 |