Powder-Free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl (White, Blue, Black, Orange And Green Color)

Polymer Patient Examination Glove

Encompass Industries Sdn. Bhd.

The following data is part of a premarket notification filed by Encompass Industries Sdn. Bhd. with the FDA for Powder-free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl (white, Blue, Black, Orange And Green Color).

Pre-market Notification Details

Device IDK220609
510k NumberK220609
Device Name:Powder-Free Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl (White, Blue, Black, Orange And Green Color)
ClassificationPolymer Patient Examination Glove
Applicant Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q Kertih BioPolymer Park Kemaman,  MY 24300
ContactNur Atikah Binti Muhammad Muhyiddin
CorrespondentNur Atikah Binti Muhammad Muhyiddin
Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q Kertih BioPolymer Park Kemaman,  MY 24300
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-02
Decision Date2022-05-27

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