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510(k) Data Aggregation
K Number
K100971Device Name
ATEK SURGICAL GOWNS
Manufacturer
HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD
Date Cleared
2010-09-27
(172 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**HANGZHOU ATEK MEDICAL **& TEXTILE CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.
Device Description
Disposable Gowns manufactured from non-woven fabric. Various sizes and materials.
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