SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)

Vinyl Patient Examination Glove

PINNACLE CO., LTD.

The following data is part of a premarket notification filed by Pinnacle Co., Ltd. with the FDA for Synthetic Vinyl Examination Glove Powder Free (yellow/white).

Pre-market Notification Details

Device IDK072228
510k NumberK072228
Device Name:SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
ClassificationVinyl Patient Examination Glove
Applicant PINNACLE CO., LTD. 240 RENMIN ROAD LINZI Shandong,  CN
ContactDavid Ding
CorrespondentDavid Ding
PINNACLE CO., LTD. 240 RENMIN ROAD LINZI Shandong,  CN
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-10
Decision Date2008-02-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10653195009982 K072228 000
10653195009968 K072228 000
10653195009951 K072228 000
10653195009920 K072228 000
10653195009906 K072228 000

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