PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE

Vinyl 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 Pre-powdered Non-sterile Synthetic Examination Glove.

Pre-market Notification Details

Device IDK982885
510k NumberK982885
Device Name:PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
ClassificationVinyl Patient Examination Glove
Applicant SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 30798 US HWY 19 N Palm Harbor,  FL  34684
ContactDon Morris
CorrespondentDon Morris
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. 30798 US HWY 19 N Palm Harbor,  FL  34684
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-17
Decision Date1998-12-04

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