The following data is part of a premarket notification filed by Fitco Dipped Products Pvt. Ltd with the FDA for Non-sterile Powder-free Latex Examination Gloves With Protein Labeling Claim 50 Micrograms Or Less.
| Device ID | K001232 |
| 510k Number | K001232 |
| Device Name: | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS |
| Classification | Latex Patient Examination Glove |
| Applicant | FITCO DIPPED PRODUCTS PVT. LTD 14-A COCHIN EXPORT PROCESSING ZONE, KAKKANAND, COCHIN 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, COCHIN Kerala, IN 682 030 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-17 |
| Decision Date | 2000-05-15 |