Powder Free Nitrile Examination Glove- Blue, Non-sterile

Polymer Patient Examination Glove

Hong Seng Gloves Sdn Bhd

The following data is part of a premarket notification filed by Hong Seng Gloves Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove- Blue, Non-sterile.

Pre-market Notification Details

Device IDK212804
510k NumberK212804
Device Name:Powder Free Nitrile Examination Glove- Blue, Non-sterile
ClassificationPolymer Patient Examination Glove
Applicant Hong Seng Gloves Sdn Bhd LOT 97, Jalan 10, Kawasan Perusahaan Bakar Arang Sungai Petani,  MY 08000
ContactHo Chia Yao
CorrespondentMichael Van Der Woude
Emergo Global Representative LLC, 2500 Bee Cave Road Building 1, Suite 300 Austin,  TX  78746
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-02
Decision Date2021-12-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09551012690051 K212804 000
09551012690044 K212804 000
09551012690037 K212804 000
09551012690020 K212804 000
09551012690013 K212804 000
09551012690006 K212804 000

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