The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Sterile Powdered Latex Surgeon Gloves.
| Device ID | K010198 |
| 510k Number | K010198 |
| Device Name: | STERILE POWDERED LATEX SURGEON GLOVES |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-02-23 |