The following data is part of a premarket notification filed by International Biomedical, Inc. with the FDA for Powder-free Radiation Attenuating Neoprene Surgical Glove (black).
| Device ID | K022873 |
| 510k Number | K022873 |
| Device Name: | POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) |
| Classification | Surgeon's Gloves |
| Applicant | INTERNATIONAL BIOMEDICAL, INC. 8508 CROSS PARK DR. Austin, TX 78754 |
| Contact | Amy R Pieper |
| Correspondent | Amy R Pieper INTERNATIONAL BIOMEDICAL, INC. 8508 CROSS PARK DR. Austin, TX 78754 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-29 |
| Decision Date | 2003-03-21 |
| Summary: | summary |