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 |