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510(k) Data Aggregation
K Number
K121998Device Name
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED
Manufacturer
CHANGZHOU HOLYMED PRODUCTS CO LTD
Date Cleared
2012-12-20
(164 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
CHANGZHOU HOLYMED PRODUCTS CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HM Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter.
HM Surgical Gowns are disposable, single use, sterile or nonsterile surgical gowns manufactured from nonwoven Spunbond-Meltblown-Spunbond (SMS) polypropylene fabrics.
Non-sterile HM surgical gowns are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and Sterile surgical gowns are to be sold directly to users after EtO sterlization validation to ISO 11135-1.
Device Description
HM Surgical Gowns are disposable, single use, sterile or nonsterile surgical gowns manufactured from nonwoven Spunbond-Meltblown-Spunbond (SMS) polypropylene fabrics. Gowns are provided in three families: Gown Family A (Non Reinforced), Gown Family B (Fabric Reinforced), and Gown Family C (Poly Reinforced). They are available in sizes M, L, XL, and XXL (with an additional XL, X-Long size in Family C) and are blue in color.
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K Number
K122000Device Name
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
Manufacturer
CHANGZHOU HOLYMED PRODUCTS CO LTD
Date Cleared
2012-12-12
(156 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
CHANGZHOU HOLYMED PRODUCTS CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
HM surgical drapes are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical drapes are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
HM surgical equipment covers are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for E!O sterflization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Device Description
Not Found
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