PATIENT EXAMINATION GLOVES

Latex Patient Examination Glove

REGO LATEX PROGRESSIVE CORP.

The following data is part of a premarket notification filed by Rego Latex Progressive Corp. with the FDA for Patient Examination Gloves.

Pre-market Notification Details

Device IDK894352
510k NumberK894352
Device Name:PATIENT EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant REGO LATEX PROGRESSIVE CORP. 2187 INT. TANIW, LUNA ST. 1300 PASAY CITY , METRO MANILA Pasay City, M.m.,  PH 1300
ContactRoberto Ong
CorrespondentRoberto Ong
REGO LATEX PROGRESSIVE CORP. 2187 INT. TANIW, LUNA ST. 1300 PASAY CITY , METRO MANILA Pasay City, M.m.,  PH 1300
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-11-03

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