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510(k) Data Aggregation
K Number
K222456Device Name
High Protection Surgical Gown
Manufacturer
Date Cleared
2023-03-12
(209 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
3A Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
High protection surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the high protection surgical gown met the requirements for Level 4 classification.
Device Description
The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.
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K Number
K202598Device Name
3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3
Manufacturer
Date Cleared
2021-05-06
(240 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
3A Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This mask is intended to be worn to protect both the patient and healthcare worker of microorganisms, body fluids and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use device provided non-sterile
Device Description
These 3 Layer Surgical Masks: Level 1, Level 2 or Level 3 (with Ear Loops or Ties) are 3 layer, flat-folded masks constructed of 100% nonwoven polypropylene materials. The masks are provided with Ear Loops (Polyester/Spandex) or Ties (Polypropylene). A malleable nose strip is placed within the binding for comfort and individualized fit. These masks meet the acceptance criteria for ASTM F 2100, Level 1, Level 2 or Level 3 performance standards and are provided in blue. These masks are single use and provided non-sterile.
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