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510(k) Data Aggregation
(617 days)
Medtecs (Taiwan) Corp.
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
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.
The provided document is a 510(k) premarket notification for a medical device, specifically a disposable gown. The acceptance criteria and the proof of meeting those criteria are detailed in the non-clinical performance testing section.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Purpose | Test Method/Standard Followed | Acceptance Criteria | Test Result |
|---|---|---|---|---|
| Hydrostatic Pressure | To determine the hydrostatic pressure of the test sample. | ATCC 127/AAMI Standard PB70 Level 4 | >50 cm H2O | Pass |
| Water Impact | To determine the Water impact of the test sample. | ATCC 42/AAMI Standard PB70 Level 4 | =7 lbf (>=30N) | Pass |
| Seam Strength | To evaluate the seam strength of the test sample by the method of Failure in Sewn Seams of Woven Fabrics. | ASTM D1683 / D1683M - 17(2018) | Seam Strength in critical zone >=7 lbf (>=30N) | Pass |
| Trapezoid Test Tear Strength | To evaluate the tearing strength of the test sample. | ASTM D5733-99/ASTM D5733-99 | Seam Strength in critical zone >=10N (>=2.3 lbf) | Pass |
| Flammability | To evaluate the flammability of the test sample in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles. | 16 CFR Part 1610/ASTM F2407-06(2013) e1, Section 6.3 flame spread | Class 1 does not Ignite | Pass |
| Resistance to Linting of Nonwoven Fabrics (Dry) | To evaluate the linting of the test sample by the method of Nonwovens-Pat 10: Lint and Other Particles Generation in the Dry State. | EN ISO 9073-10:2004/EN 13795-1:2019 | Requirement Coefficient of linting |
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(470 days)
Medtecs (Taiwan) Corp.
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.
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.
The provided text is related to the FDA 510(k) clearance for a surgical mask. It details the device description, intended use, and a comparison of technological characteristics and performance between the subject device and a predicate device.
However, the questions you've asked about "acceptance criteria and the study that proves the device meets the acceptance criteria" are typically associated with artificial intelligence (AI) or machine learning (ML) medical devices, which involve performance evaluation against ground truth established by experts.
The document provided is for a physical medical device (a surgical mask) and its performance is evaluated against established physical and biological standards (e.g., fluid resistance, bacterial filtration efficiency, flammability, biocompatibility). It does not involve AI/ML performance metrics, expert adjudication, or MRMC studies.
Therefore, I cannot answer your specific questions based on the provided text, as they are not relevant to the type of device and study described in the FDA 510(k) submission for a surgical mask.
To give a complete answer, I would need a document related to an AI/ML medical device submission.
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