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510(k) Data Aggregation
K Number
K112136Device Name
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
Manufacturer
Date Cleared
2011-09-29
(65 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable sterile drapes are intended for use for :
- patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures.
- cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures
Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135.
Device Description
The document lists the following disposable surgical drape types and model numbers included in the submission:
| MATERIAL | DRAPE STYLE | STERILE | DRAPE TYPE | MODEL # |
|----------|-------------------|-------------|------------|-----------------|
| SMS | Non<br>Reinforced | Sterile | Top | JHSAD 150-240E |
| | | | Bottom | JHSAD 180-175E |
| | | Non Sterile | Top | JHSAD 150-240NS |
| | | | Bottom | JHSAD 180-175NS |
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K Number
K111067Device Name
JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
Manufacturer
Date Cleared
2011-08-02
(106 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 are 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
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