Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue

Vinyl Patient Examination Glove

ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD.

The following data is part of a premarket notification filed by Zibo Huiying Medical Products, Co. Ltd. with the FDA for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue.

Pre-market Notification Details

Device IDK153028
510k NumberK153028
Device Name:Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
ClassificationVinyl Patient Examination Glove
Applicant ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD. NO. 3 DA WU ROAD Linzi,  CN 255400
ContactFufang Wang
CorrespondentSophie Hao
BASIC MEDICAL INDUSTRIES, INC. 12390 East End Ave Chino,  CA  91710
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-16
Decision Date2016-02-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00097604794541 K153028 000
B845VGPF10153 K153028 000
B845VGPF10163 K153028 000
B845VGPF10173 K153028 000
B845BMPF20143 K153028 000
B845BMPF20153 K153028 000
B845BMPF20163 K153028 000
B845BMPF20173 K153028 000
20847212007908 K153028 000
00097604794510 K153028 000
00097604794527 K153028 000
00097604794534 K153028 000
B845VGPF10143 K153028 000

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