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 |