FDA.reportPublic FDA data

510(k) K010211

Device
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
Applicant
Allegiance Healthcare Corp.
510(k) number
K010211
Product code
LZC
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-15
Date received
2001-01-23
Regulation
880.6250
Classification name
Medical Glove, Specialty
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ERICA SETHI
Address
1500 Waukegan Rd.- K Mcgraw Park IL US 60085 60085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZC#

510(k), Device, Applicant table
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K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd2022-05-26
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K220353Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy DrugsNiujian Technology Co., Ltd.2022-03-31
K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsChangzhou Universal Medical Equipment Co., Ltd.2022-03-10
K213325Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy DrugsAnhui Xinyisheng Medical Technology Co.,Ltd2022-01-28
K213076AspenMed+Aspen Glove Sdn. Bhd.2021-12-20
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K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugsJr Engineering & Medical Technologies (M) Sdn. Bhd.2021-12-06
K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove0 & M Halyard, Inc.2020-10-11
K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)Medline Industires, Inc.2020-09-18
K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl CitrateEver Global (Vietnam) Enterprise Corp2020-06-04