FDA.reportPublic FDA data

K2 HEALTH PRODUCTS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30072207263007220726K2 HEALTH PRODUCTS1Y2026-01-015377 Kings Hwy Brooklyn NY US 11203

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
933431763900234K231439Powder Free White, Black, and Purple Nitrile Examination GloveLZA2023-08-11
933431588569668K223444Powder Free Blue Nitrile Examination GloveLZA2023-02-06
933431255293648K212998Powder Free Nitrile Examination Gloves (White, Blue and Black)LZA2022-02-19
933432060254926K212847Penta GloveLZA2022-01-06
933431106228596K201428Powder Free Black Nitrile Examination GloveLZA2021-06-24
933431273265778K192444mCare® Powder Free Nitrile Black Examination GloveLZA2019-12-31
933431460940967K182640Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)LZA2019-04-12
933431276516291K172930mCare Powder-free Blue Nitrile Examination GlovesLZA2018-04-13
933431488784118K170393Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)LZA2017-05-09
933431151834155K153562Powder Free Blue Nitrile Examination GloveLZA2016-04-01
933431093425754K123590VINYL EXAMINATION POWDER FREE GLOVES, CLEARLYZ2013-06-17
933431113511182K112266POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLORLYZ2012-05-08
933431446069464K111012SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)LYZ2011-07-06
933431177304152K090520STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)LYZ2009-05-18
933431245229045K090513VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)LYZ2009-05-08
933431281563253K072228SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)LYZ2008-02-08
933431844860698
933431880799424
933431113124244
933431341644361
933431462913310
933431694896335
933431891161106
933431994673624
933432049168016
933432057225704

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA102023-08-11
LYZ62013-06-17