The following data is part of a premarket notification filed by Pt Nusa Dipa Perdana with the FDA for Protex Patient Examination Gloves (latex).
| Device ID | K892115 |
| 510k Number | K892115 |
| Device Name: | PROTEX PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | PT NUSA DIPA PERDANA 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz PT NUSA DIPA PERDANA 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 | 1989-04-04 |
| Decision Date | 1989-04-25 |