NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR

Polymer Patient Examination Glove

SGMP CO., LTD.

The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Non-sterile, Powder Free Black Nitrile Examination Gloves With Cherry Flavor.

Pre-market Notification Details

Device IDK101646
510k NumberK101646
Device Name:NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
ClassificationPolymer Patient Examination Glove
Applicant SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434
ContactJanna P Tucker
CorrespondentJanna P Tucker
SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-11
Decision Date2010-09-08
Summary:summary

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