MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)

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 Multiple Private Labels, Nitrile Exam Gloves, Powder-free (white).

Pre-market Notification Details

Device IDK001549
510k NumberK001549
Device Name:MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
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 Received2000-05-18
Decision Date2000-06-12

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