ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Surgeon's Gloves

ANSELL PERRY

The following data is part of a premarket notification filed by Ansell Perry with the FDA for Encore Microptic Powder Free Latex Surgical Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).

Pre-market Notification Details

Device IDK000295
510k NumberK000295
Device Name:ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
ClassificationSurgeon's Gloves
Applicant ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
ContactJames R Chatterton
CorrespondentJames R Chatterton
ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-31
Decision Date2000-02-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20811220031194 K000295 000
20811220031187 K000295 000
20811220031170 K000295 000
20811220031163 K000295 000
20811220031156 K000295 000
20811220031149 K000295 000
20811220031132 K000295 000
20811220031125 K000295 000

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