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 |