NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW

Latex 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 Pink Latex Examination Glove And Non-sterile Powder Free Pink Latex Examination Glove With Straw.

Pre-market Notification Details

Device IDK011371
510k NumberK011371
Device Name:NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
ClassificationLatex 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 CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-04
Decision Date2001-06-07

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