The following data is part of a premarket notification filed by Fitco Dipped Products Pvt. Ltd with the FDA for Latex Surgical Gloves, Pre-powdered.
| Device ID | K993450 |
| 510k Number | K993450 |
| Device Name: | LATEX SURGICAL GLOVES, PRE-POWDERED |
| Classification | Surgeon's Gloves |
| Applicant | FITCO DIPPED PRODUCTS PVT. LTD 14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, COCHIN Kerala, IN 682 030 |
| Contact | Joseph Pereira |
| Correspondent | Joseph Pereira FITCO DIPPED PRODUCTS PVT. LTD 14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, COCHIN Kerala, IN 682 030 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-12 |
| Decision Date | 1999-12-29 |
| Summary: | summary |