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510(k) Data Aggregation
K Number
K121152Device Name
SURGICAL GOWN, SMS
Manufacturer
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD
Date Cleared
2012-12-12
(240 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Jiangsu Guangda's Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.
Device Description
Jiangsu Guangda's Disposable XLarge Reinforced Surgical Gowns, Model Number GD-SG-01, are made from SMS fabrics and PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs to provide user protection in surgical settings.
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