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510(k) Data Aggregation
K Number
K222642Device Name
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
Manufacturer
Inner Mongolia Cureguard Medical Technology Co.,Ltd.
Date Cleared
2022-09-20
(19 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Inner Mongolia Cureguard Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.
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K Number
K212661Device Name
Disposable Nitrile Examination Glove
Manufacturer
Inner Mongolia Cureguard Medical Technology Co.,Ltd.
Date Cleared
2021-11-19
(88 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Inner Mongolia Cureguard Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile patient examination gloves. The subject device is white color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
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K Number
K212401Device Name
Disposable Nitrile Examination Glove
Manufacturer
Inner Mongolia Cureguard Medical Technology Co.,Ltd.
Date Cleared
2021-10-25
(84 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Inner Mongolia Cureguard Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile patient examination gloves. The subject device is blue color and has 5 models of XS,S, M, L, XL. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
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