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510(k) Data Aggregation
K Number
K021533Device Name
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
Manufacturer
Date Cleared
2003-03-05
(299 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
CREATIVE CONTRACT (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask is a high filtration 3 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials.
Device Description
Not Found
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K Number
K021539Device Name
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
Manufacturer
Date Cleared
2003-03-05
(299 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
CREATIVE CONTRACT (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask is a high filtration 4 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials.
Device Description
DermAssist ™ Fluid Resistant Surgical Mask (Tie On Style) / Procedure Mask (Ear Loop Style)
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K Number
K021546Device Name
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
Manufacturer
Date Cleared
2003-03-05
(299 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
CREATIVE CONTRACT (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask with WrapAround Visor is a high filtration 4 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials. The WrapAround Visor is a 3M ® Anti Fogging Visor, is intended to act as a face shield or an eye shield, during instances where blood and bodily fluids may be splashed upon the surgeon or medical healthcare personnel.
Device Description
DermAssist ™ Fluid Resistant Surgical Mask (Tie On Style) with WrapAround Visor / Procedure Mask (Ear Loop Style) with WrapAround Visor
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