The following data is part of a premarket notification filed by Pt Citra Latex Lestari with the FDA for Citrex Latex Examination Gloves.
| Device ID | K895722 |
| 510k Number | K895722 |
| Device Name: | CITREX LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT CITRA LATEX LESTARI 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz PT CITRA LATEX LESTARI 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-10-13 |