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510(k) Data Aggregation
K Number
K062479Device Name
JOYKEY SURGICAL GOWNS (STERILE)
Manufacturer
Date Cleared
2007-03-14
(202 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
JOYKEY INDUSTRYIAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only.
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K Number
K062480Device Name
JOYKEY SURGICAL DRAPES (STERILE)
Manufacturer
Date Cleared
2007-03-05
(193 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
JOYKEY INDUSTRYIAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
JOYKEY Surgical Drapes (Sterile) are single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Device Description
JOYKEY Surgical Drapes (Sterile), are manufactured from non-woven fabric, PE & Reinforce layer. The Surgical Drapes include (3) basic configurations of SPLIT DRAPE, THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes are supplied sterile and for single use only.
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