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510(k) Data Aggregation
K Number
K230304Device Name
Polyisoprene Surgical Gloves
Manufacturer
Date Cleared
2023-08-09
(187 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Puyang Linshi Medical Supplies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
Device Description
The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.
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