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510(k) Data Aggregation
K Number
K192933Device Name
Polyisoprene Powder Free, Black Colour Surgical Gloves
Manufacturer
Emerson & Co. Srl
Date Cleared
2021-01-13
(454 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
**Emerson **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22 mm Model 2: 0.30 mm
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K Number
K151228Device Name
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
Manufacturer
EMERSON & CO. S.R.L.
Date Cleared
2016-01-15
(253 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
**EMERSON **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22mm Model 2: 0.30mm
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K Number
K002598Device Name
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
Manufacturer
J. H. EMERSON CO.
Date Cleared
2000-11-22
(93 days)
Product Code
NHJ
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
**EMERSON **CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982832Device Name
PROGUARD, RR-1, RR-2
Manufacturer
EMERSON & CO. S.R.L.
Date Cleared
1998-12-23
(133 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**EMERSON **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-Ray protection gloves PROGUARD are sterile examination gloves, radio-opaque, to be worn by hospital personnel, specifically surgeons, to protect their hands from radiation during operation of x-ray equipment. These gloves are destined to specific examination purposes. They are not intended to be used instead of a Radiographic Protective Gloves, normally used in radiography for those studies which need the physician's hands or forearms to be inserted intop the primary x-ray beam, but not the sterility or the degree of manual dexterity allowed by the PROGUARD.
Moreover these gloves are not to be used in or next to the primary x-ray beam or conducted primary x-ray beam. The main purpose of these gloves is to reduce the amount of dispersed radiation exposure to the hands from the primary x-ray beam during examinations or procedures under fluoroscopy performance.
Device Description
This product contains natural rubber latex. The gloves are a product of Malaysia. The manufacturer of these latex-lead gloves complies with all the current specifications listed under The American ociety for testing and Materials (ASTM) Specification D 3578 -91 and FDA Water Leak Test.
The quality assurance testing for the finished product includes testing for physical properties such as tensile strength and elongation: dimensions such as length, width and thickness; visual tests such as colour and material uniformity. In addition, sampling and testing for leaks conforms to the FDA Water Leak Test for patient examination gloves.
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