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510(k) Data Aggregation
K Number
K060776Device Name
SURGICAL FACE MASK
Manufacturer
HONG YA NON-WOVEN PRODUCTS CO., LTD.
Date Cleared
2006-05-25
(64 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
HONG YA NON-WOVEN PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Face Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
Device Description
Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded I mk) are nat produce o psy (a a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is malleable aluminum wire. All the materials used in the construction of the Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are being used in currently marked devices.
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K Number
K043199Device Name
SURGICAL FACE MASK
Manufacturer
HONG YA NON-WOVEN PRODUCTS CO., LTD.
Date Cleared
2005-02-16
(90 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
HONG YA NON-WOVEN PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Face Mask is device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
Device Description
Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is flat pleated 3-ply masks with an inner and outer layer (spunbonded polypropylene) that sandwich a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is malleable aluminum wire. All the material used in the construction of the Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) are being used in currently marked devices.
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