The following data is part of a premarket notification filed by Ganz Industries Sdn. Bhd. with the FDA for Acrylic Dipped Latex Surgical Gloves - Sterile.
| Device ID | K945505 |
| 510k Number | K945505 |
| Device Name: | ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE |
| Classification | Surgeon's Gloves |
| Applicant | GANZ INDUSTRIES SDN. BHD. PT NO. 3367, JALAN AM 2 ARAB MALAYSIAN INDUSTRIAL PARK Nilai 71800, Negeri Sembilan, MY |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-08-18 |