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 |