POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

Vinyl Patient Examination Glove

SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Shandong Binxiang Medical Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK131832
510k NumberK131832
Device Name:POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino,  CA  91710
ContactRay Zhou
CorrespondentRay Zhou
SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino,  CA  91710
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-20
Decision Date2014-01-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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B3408617L1 K131832 000
B3408617M1 K131832 000
B3408617S1 K131832 000
00616784261614 K131832 000
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00649531920144 K131832 000
00649531920168 K131832 000
B3408617XL1 K131832 000

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