The following data is part of a premarket notification filed by Cardinal Health,medical Products And Services with the FDA for Ultrafree Textured Sterile Latex Powder-free Surgical Gloves.
| Device ID | K983962 |
| 510k Number | K983962 |
| Device Name: | ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES 1500 WAUKEGAN RD. BUILDING K Mcgaw Park, IL 60085 |
| Contact | Erica Sethi |
| Correspondent | Erica Sethi CARDINAL HEALTH,MEDICAL PRODUCTS AND SERVICES 1500 WAUKEGAN RD. BUILDING K Mcgaw Park, IL 60085 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-06 |
| Decision Date | 1999-01-08 |
| Summary: | summary |