The following data is part of a premarket notification filed by Intl. Trading Ventures, Inc. with the FDA for Sterile Surgical Latex Gloves.
Device ID | K883824 |
510k Number | K883824 |
Device Name: | STERILE SURGICAL LATEX GLOVES |
Classification | Surgeon's Gloves |
Applicant | INTL. TRADING VENTURES, INC. 1201 LEXINGTON AVE. SUITE 1C New York, NY 10028 |
Contact | Joel H Freschl |
Correspondent | Joel H Freschl INTL. TRADING VENTURES, INC. 1201 LEXINGTON AVE. SUITE 1C New York, NY 10028 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-09 |
Decision Date | 1988-10-13 |