The following data is part of a premarket notification filed by Rego Latex Progressive Corp. with the FDA for Patient Examination Gloves.
| Device ID | K894352 |
| 510k Number | K894352 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | REGO LATEX PROGRESSIVE CORP. 2187 INT. TANIW, LUNA ST. 1300 PASAY CITY , METRO MANILA Pasay City, M.m., PH 1300 |
| Contact | Roberto Ong |
| Correspondent | Roberto Ong REGO LATEX PROGRESSIVE CORP. 2187 INT. TANIW, LUNA ST. 1300 PASAY CITY , METRO MANILA Pasay City, M.m., PH 1300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-11-03 |