VINYL EXAMINATION GLOVES (NON STERILE)

Vinyl Patient Examination Glove

ARISTA LATINDO INDUSTRIAL, LTD. P.T.

The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Vinyl Examination Gloves (non Sterile).

Pre-market Notification Details

Device IDK934536
510k NumberK934536
Device Name:VINYL EXAMINATION GLOVES (NON STERILE)
ClassificationVinyl Patient Examination Glove
Applicant ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta,  ID 11210
ContactGentho Sumarta
CorrespondentGentho Sumarta
ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta,  ID 11210
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-20
Decision Date1994-06-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.