The following data is part of a premarket notification filed by Fitco Dipped Products Pvt. Ltd with the FDA for Powderfree Latex Surgeon's Gloves With Protien Labeling Claim (50 Mocrograms Or Less.
| Device ID | K000896 |
| 510k Number | K000896 |
| Device Name: | POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS |
| Classification | Surgeon's Gloves |
| Applicant | FITCO DIPPED PRODUCTS PVT. LTD 14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, KOCHI Kerala, IN 682 030 |
| Contact | Joseph J E Pereira |
| Correspondent | Joseph J E Pereira FITCO DIPPED PRODUCTS PVT. LTD 14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, KOCHI 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 | 2000-03-20 |
| Decision Date | 2000-05-03 |