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510(k) Data Aggregation
K Number
K213688Device Name
Nitrile Examination Gloves (Model: ZMG1351)
Manufacturer
Wuhan Zonsen Medical Products Co.,Ltd
Date Cleared
2022-02-18
(87 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Zonsen Medical Products Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only.
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K Number
K212861Device Name
Surgical Gown, Reinforced Surgical Gown
Manufacturer
Wuhan Zonsen Medical Products Co.,Ltd
Date Cleared
2021-12-15
(98 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Zonsen Medical Products Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 classification.
Device Description
The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.
The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
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