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510(k) Data Aggregation
K Number
K210414Device Name
CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
Manufacturer
Medtecs (Taiwan) Corp.
Date Cleared
2022-10-21
(617 days)
Product Code
FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Medtecs (Taiwan) Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown (Model number: IL4036YKTP-L4) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile.
The CoverU Disposable Gown with Tape - Chemo Gown (Model number IL-4036YKTP-CM) is intended to provide barrier protection and protect healthcare personnel and patients from the transfer of microorganisms, body fluids and particulate material. CoverU Disposable Gown with Tape meets the requirements of AAMI Level 4 barrier protection for a surgical isolation gown per ANSI/ AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Not intended for use in the operating room. CoverU Disposable Gown with Tapes is a single use, disposable medical device provided non-sterile. The gowns have been evaluated for resistance to permeation of various chemotherapy drugs per ASTM F739-12, Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. Chemotherapy drug permeation resistance, average standardized breakthrough time in minutes *:
Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etopside [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 lfosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 Docetaxel [10mg/ml] >480 Oxaliplatin [5mg/ml] >480 Leucovorin [10mg/ml] >480
*No permeation was detected at either the minimum detectable permeation or 0.1 ug/cm2/min
Device Description
The CoverU Disposable Gown with Tape is constructed of PPSB Coated PE materials with the color in yellow. It is sealed the seam by Adheresive tape provide protection from liquid borne. The sleeves of the gown have knit cuffs sewn onto the end of the sleeve at the user's wrists to keep the sleeves in place on the wearer. Tie at the neck and waist for secure protection AAMI level 4 standard provides high performance on hydrostatic pressure and fluids impact.
The CoverU Disposable Gown with Tape is sold in one size, non-sterile and is intended to be a single use, disposable device, and does NOT contain any drugs or biologics and not made with natural rubber latex. The two gown models are exact the same gowns, except the chemo-drug labeling claim. one is intended to protect workers from high fluid level (blood body fluids etc.) and blood borne pathogen, and the other is intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. Ten (10) pieces of CoverU Disposable Gown with Tape are packaged in a plastic bag and ten bags are outer packaging with a paper carton box. These gowns are offered in a universal size.
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K Number
K203376Device Name
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
Manufacturer
Medtecs (Taiwan) Corp.
Date Cleared
2022-03-02
(470 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Medtecs (Taiwan) Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are intended to be 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. The face masks are single use, disposable device, provided non-sterile.
Device Description
The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond non-woven polypropylene and the middle layer is constructed of melt blown non-woven polypropylene. The mask is held in place over the mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with Galvanized iron wire and allows the user to fit the facemask around their nose. The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is sold non-sterile and is intended to be a single use, disposable device.
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