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510(k) Data Aggregation
K Number
K160337Device Name
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
Manufacturer
BAM CORPORATION LIMITED
Date Cleared
2017-07-07
(515 days)
Product Code
QPC, FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
BAM CORPORATION LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective . They are not intended for use in the operating room.
Device Description
SafeCare® Open Back Protective Gowns (Models: 46969-097X, 46969097XB, 46969097X-10, 46969-098 & 46969-098D) and ValueCare® Open Back (Model: 4550-25X) Protective Gowns are open back gowns made from extruded plastic film.
The SafeCare® and ValueCare® Open Back Protective gowns provide barrier protection to the wearer from body fluids and particulate materials and have passed barrier testing according to ANSI/AAMI PB70:2012 Level 3 protection or equivalent.
The significant design points of the gowns are:
1. Made from extruded plastic film to provide an effective barrier meeting the requirements for penetration testing as per ANSI/AAMI PB70: 2012 Level 3 according to AATCC 42:2013 and AATCC 127:2014 test methods.
2. Backless to provide comfort
3. Thumb loops at the wrist which help to hold gown sleeves down
4. Back has perforations so the gowns can be removed without taking over the head in case they are contaminated
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