Search Results
Found 4 results
510(k) Data Aggregation
K Number
K211515Device Name
Nitrile Examination Gloves
Manufacturer
Beijing Reagent Latex Products Co., Ltd.
Date Cleared
2021-08-24
(99 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Beijing Reagent Latex Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The Beijing Reagent Latex Products Co., Ltd. Nitrile Examination Gloves are powder-free Class I patient examination gloves are manufactured from nitrile and are blue in color. The examination gloves are intended for medical purpose, will be worn on the examiner's hand, and will be available in four sizes (Small, Medium, Large, and Extra-Large).
Ask a Question
K Number
K062797Device Name
POWDERED LATEX SURGICAL GLOVE
Manufacturer
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
Date Cleared
2007-04-11
(204 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Powdered Latex Surgical Glove is a disposable device made of natural rubber latex material that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical setting, to provide a barner against potentially infectious materials and other contaminants.
Device Description
Powdered Latex Surgeon's Glove
Ask a Question
K Number
K012104Device Name
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
Manufacturer
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
Date Cleared
2001-08-21
(47 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Powder Free Latex Surgical Glove is a disposable device intended in surgical settings for medical purpose that is worn on the hand to provide a barrier against potentially infectious materials and other contaminants.
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by the are and A surgeon's grove 15 a device intraction wound from contamination. (21CFR 878.4460)
Device Description
Class I Surgeon's Glove (Powder Free) 79KGO that meets all the requirement of ASTM D3577.
Ask a Question
K Number
K010947Device Name
SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
Date Cleared
2001-05-25
(57 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BEIJING REAGENT LATEX PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1