NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE

Polymer Patient Examination Glove

SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Shanghai Poseidon Plastic Products Co., Ltd. with the FDA for Nitrile Examination Gloves, Pre-powdered, Color Blue.

Pre-market Notification Details

Device IDK001837
510k NumberK001837
Device Name:NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
ClassificationPolymer Patient Examination Glove
Applicant SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434 -9550
ContactJanna P Tucker
CorrespondentJanna P Tucker
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434 -9550
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-16
Decision Date2000-07-11

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