The following data is part of a premarket notification filed by Fitco Dipped Products Pvt. Ltd with the FDA for Powder-free Latex Examination Glove Sterile With Optional Protein Labeling Claim (50 Micrograms Or Less).
| Device ID | K001216 |
| 510k Number | K001216 |
| Device Name: | POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL 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 | 2000-04-14 |
| Decision Date | 2000-04-28 |