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510(k) Data Aggregation
(222 days)
Sri Trang Gloves (Thailand) Public Company Limited
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes
Busulfan 6 mg/mL, >240 minutes
Carboplatin (Paraplatin) 10 mg/mL, >240 minutes
Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes
Cisplatin 1.0 mg/mL, >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes
Cytarabine HC1 100 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes
Daunorubicin HC1 5 mg/mL, >240 minutes
Docetaxel 20 mg/mL, >240 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes
Epirubicin HC1 (Ellence) 2 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes
Fluorouracil 50 mg/mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin HCl 1 mg/mL, >240 minutes
lfosfamide 50 mg/mL, >240 minutes
Irinotecan 20 mg/mL, >240 minutes
Mechlorethamine HC1 1 mg/mL, >240 minutes
Melphalan 5 mg/mL, >240 minutes
Methotrexate 25 mg/mL, >240 minutes
Mitomycin C 0.5 mg/mL, >240 minutes
Mitoxantrone 2 mg/mL, >240 minutes
Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Rituximab 10 mg/mL, >240 minutes
Thiotepa 10 mg/mL, 3.7 minutes
Trisenox 1 mg/mL . >240 minutes
Vincristine Sulfate 1 mg/mL, >240 minutes
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about acceptance criteria or a study proving a device meets acceptance criteria related to a medical imaging AI device or similar complex medical technology.
The text exclusively details the clearance of Latex Examination Gloves Powder Free (Ocean Blue and Natural White), citing regulation numbers, product codes, and the review process for market clearance. It mentions general controls, quality system regulations, UDI rules, and reporting of adverse events, all pertaining to the manufacturing and marketing of physical medical devices (gloves in this case), not performance studies of an AI algorithm or diagnostic device.
Therefore, I cannot extract the information required to answer your specific questions about acceptance criteria, study design, ground truth, or expert involvement, as this information is not present in the provided document.
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(89 days)
Sri Trang Gloves Thailand (Public Company Limited)
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL. >240 minutes Busulfan 6 mg/mL, >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 23.5 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL. >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) IO mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel IO mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL, >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes Bendamustine (5.0 mg / ml), > 240 minutes Oxaliplatin (5.0 mg / ml), > 240 minutes Azacitidine (Vidaza] (25.0 mg / ml) ,> 240 minutes Capecitabine (26.0 mg / ml), > 240 minutes Cladribine (1.0 mg / ml), > 240 minutes Decitabine (5.0 mg / ml) ,> 240 minutes Pemetrexed (25.0 mg / ml), > 240 minutes Raltitrexed (0.5 mg / ml), > 240 minutes Actinomycin D (0.5mg / ml)(Dactinomycin), > 240 minutes Vinorelbine (10.0 mg / ml), > 240 minutes Vinblastine (1.0 mg / ml), > 240 minutes
Fentanyl tested as follows; Fentanyl citrate 100 mcg/2mL. >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
lfosfamide 50 mg/mL. >240 minutes Irinotecan 20 mg/mL. >240 minutes Mechlorethamine I mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL. >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL. >240 minutes Thiotepa 10 mg/mL, 37.9 minutes Trisenox 1 mg/mL . >240 minutes Vincristine Sulfate I mg/mL, >240 minutes Topotecan (1.0 mg / ml), >240 minutes Carfilzomib (2.0 mg / ml), >240 minutes Cetuximab [Erbitux] (2.0 mg / ml), > 240 minutes Temsirolimus (25.0 mg / ml), > 240 minutes Bortezomib [Velcade] (1.0 mg / ml), > 240 minutes Fulvestrant (50.0mg / ml),> 240 minutes Leuprorelin acetate (5.0 mg / ml), > 240 minutes Ganciclovir [Cytovene] (10.0 mg / ml), > 240 minutes Zidopusin (Retrovir) (10.0 mg / ml), > 240 minutes Zoledronic acid (0.8 mg / ml), > 240 minutes Triclosan (3.0 mg / ml), > 240 minutes Chloroquine (50.0 mg / ml), > 240 minutes Cyclosporine A (100.0 mg / ml) , > 240 minutes Propofol (10 mg/ml) (Diprivan), > 240 minutes MESNA (100 mg/ml), > 240 minutes
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl-Blue. THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
The provided text is a 510(k) premarket notification letter from the FDA regarding a non-sterile, powder-free nitrile examination glove. It does not contain information about acceptance criteria or a study proving device performance for an AI/ML powered medical device.
The information primarily focuses on the regulatory classification, general controls, and indications for use of the examination gloves, including their permeation times for various chemotherapy drugs and fentanyl.
Therefore, I cannot provide the requested information about acceptance criteria and a study for an AI/ML device based on the given input.
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(259 days)
Sri Trang Gloves (Thailand) Public Company Limited
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/mL, 23 minutes Cisplatin 1.0 mg/mL. >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 68.2 minutes Vincristine Sulfate 1.0 mg/mL, >240 minutes
WARNING: Not for use with Carmustine and Thiotepa.
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Violet Blue)
The document provided is an FDA clearance letter for a medical device: "Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl".
This document does not contain information about acceptance criteria or a study proving the performance of a device that uses AI/ML or requires ground truth establishment by experts.
The product being cleared is a nitrile examination glove, which is a physical medical device. The 'testing' referred to in the document is chemical resistance testing against specific chemotherapy drugs and fentanyl, not performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample size for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study or effect size
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a standard FDA 510(k) clearance letter confirming substantial equivalence to a predicate device, based on the testing of the glove's resistance to certain chemicals, and general device characteristics (e.g., non-sterile, powder-free). It does not involve complex data analysis, expert reads, or AI/ML algorithm validation as would be the case for an AI/ML-driven medical device.
Ask a specific question about this device
(212 days)
Sri Trang Gloves (Thailand) Public Company Limited
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PROPOSE THAI IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl
Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
The provided document is a 510(k) clearance letter from the FDA for medical gloves, specifically "Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl" and "Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl".
This document does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves it meets those criteria. It is entirely focused on the regulatory clearance of examination gloves, outlining their indications for use, the chemotherapy drugs they were tested against, and fentanyl permeation times. There is no mention of algorithms, machine learning, human readers, or any other aspects related to AI/ML device evaluation.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this document.
Ask a specific question about this device
(365 days)
Sri Trang Gloves (Thailand) Public Company Limited
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.
Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device that would involve AI, human readers, or specific performance metrics like sensitivity or specificity.
The document is a 510(k) clearance letter from the FDA for Non-sterile, Powder-Free Latex Examination Gloves. This type of device does not typically involve complex performance studies with AI, human interpretation, or ground truth establishment in the way described in your request. The clearance is based on substantial equivalence to legally marketed predicate devices, and the "Indications for Use" section simply describes the intended use of the gloves for preventing contamination.
Therefore, I cannot provide the requested information as it is not present in the given text.
Ask a specific question about this device
(259 days)
Sri Trang Gloves (Thailand) Public Company Limited
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove contains 50 micrograms or less of total water extractable protein per gram.
CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions
Non-sterile, Powder-Free Latex Examination Glove
This document is a 510(k) premarket notification decision letter from the FDA for a Non-sterile, Powder-Free Latex Examination Glove. It is not for a medical device that utilizes AI or algorithmic performance, therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, and expert involvement is not applicable to this document.
The document discusses substantial equivalence to predicate devices for a physical product (gloves) and outlines regulatory requirements for such products, not performance metrics for an AI/algorithm-based device.
Ask a specific question about this device
(37 days)
Sri Trang Gloves (Thailand) Public Company Limited
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows: Carmustine (BCNU) 3.3 mg/mL, 11.6 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 36.2 minutes Vincristine Sulfate 1.0 mg/mL. >240 minutes WARNING: Not for use with Carmustine and Thiotepa.
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
Non-sterile, Powder-Pree Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
This document is a 510(k) premarket notification from the FDA, classifying a "Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl" as a Class I device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance because an AI/ML device is not being submitted.
The requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance) would typically be found in regulatory submissions for AI/ML-driven medical devices. However, this document pertains to a medical glove and therefore does not include such details.
Ask a specific question about this device
(88 days)
Sri Trang Gloves (Thailand) Public Company Limited
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL. >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL. >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes
Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine 1 mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 27.9 minutes Trisenox 1 mg/mL , >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL. >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.
This document is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence of a new medical device (nitrile exam gloves) to a legally marketed predicate device. It contains a section on non-clinical performance testing which describes the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" for various physical and chemical properties of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comprehensive table for various physical and chemical properties of the gloves under "H. Summary of Non-Clinical Performance Testings". The device is presented in three models: NOF_SD Orchid, NOF_SL Lilac, and NOF_EL Oyster.
| Measurement | Standard Criteria | Reported Device Performance (NOF_SD Orchid) | Reported Device Performance (NOF_SL Lilac) | Reported Device Performance (NOF_EL Oyster) |
|---|---|---|---|---|
| Tensile strength (Before aging) | 14 MPa Min (per ASTM D 6319-10) | 33 MPa | 34 MPa | 37 MPa |
| Tensile strength (After aging) | 14 MPa Min (per ASTM D 6319-10) | 37 MPa | 38 MPa | 41 MPa |
| Ultimate elongation (Before aging) | 500% Min (per ASTM D 6319-10) | 630% | 570% | 564% |
| Ultimate elongation (After aging) | 400% Min (per ASTM D 6319-10) | 625% | 535% | 551% |
| Length | 230 mm Min (M) | 240 mm | 238 mm | 240 mm |
| Thickness (Single wall Finger) | 0.05 mm Min | 0.14 mm | 0.08 mm | 0.08 mm |
| Thickness (Single wall Palm) | 0.05 mm Min | 0.10 mm | 0.06 mm | 0.05 mm |
| Width | 110 +/- 10 mm (M) | 111 mm | 110 mm | 110 mm |
| Freedom from holes | GI, AQL 2.5 (Accept - 7, Reject - 8) | 0 | 1 | 1 |
| Powder Residue | 2.0 mg/glove | 0.5 mg/glove | 0.3 mg/glove | 0.5 mg/glove |
| Chemotherapy Drug Permeation (Various drugs) | No breakthrough up to 240 minutes (for most drugs listed) | (See detailed table below for each drug) | (See detailed table below for each drug) | (See detailed table below for each drug) |
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time):
| Test Drug and Concentration | Standard Criteria (Minimum Breakthrough Detection Time) | NOF_SD Orchid | NOF_SL Lilac | NOF_EL Oyster | Steady State Perm. Rate (for some) |
|---|---|---|---|---|---|
| Bleomycin Sulfate 15,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Busulfan 6,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carboplatin 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carmustine (BCNU) 3,300 ppm | Not explicitly stated as "accepted", but tested | 17.1 minutes | 22.8 minutes | 22.3 minutes | 0.4, 0.4, 0.3 |
| Cisplatin 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytoxan 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytarabine 100,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| DTIC 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Daunorubicin 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Docetaxel 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Doxorubicin hydrochloride 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Epirubicin 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Etoposide (Toposar) 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fludarabine 25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fluorouracil 50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Gemcitabine 38,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Idarubicin 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Ifosfamide 50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Irinotecan 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mechlorethamine 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Melphalan 5,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Methotrexate 25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitomycin C 500 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitoxantrone 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Taxol 6,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Rituximab 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Thiotepa 10,000 ppm | Not explicitly stated as "accepted", but tested | 27.9 minutes | 39.1 minutes | 39 minutes | 0.3, 0.3, 0.2 |
| Trisenox 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Vincristine sulfate 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fentanyl Citrate 100 mcg/2mL | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Biocompatibility | (No specific numerical criteria, qualitative result) | Not an irritant | Not an irritant | Not an irritant | N/A |
| In vitro cytotoxicity | (No specific numerical criteria, qualitative result) | Cytotoxic | Cytotoxic | Cytotoxic | N/A |
| Systemic toxicity | (No specific numerical criteria, qualitative result) | No systemic response | No systemic response | No systemic response | N/A |
| Guinea Pig Sensitization | (No specific numerical criteria, qualitative result) | Not a sensitizer | Not a sensitizer | Not a sensitizer | N/A |
Important Note: The document explicitly states "WARNING: Not for use with Carmustine or Thiotepa" in the Indications for Use section (page 2), despite reporting specific breakthrough times for these drugs, indicating that these shorter permeation times (17.1-22.8 minutes for Carmustine and 27.9-39.1 minutes for Thiotepa) are below an acceptable level for safe use with these particular chemotherapy drugs.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document specifies sample sizes for a few tests:
- Freedom from holes: 125 samples for each model (NOF_SD Orchid, NOF_SL Lilac, NOF_EL Oyster) (page 8).
- Powder Residue: N=5 (number of gloves tested, AQL=N/A) (page 10).
- Tensile strength and ultimate elongation: Inspection Level: S-2 (page 10).
- Length, thickness, and width: Inspection Level: S-2 (page 10).
- Data Provenance: The tests are described as "Non-Clinical Performance Testings" conducted to demonstrate the device met design specifications. The submitting entity is Sri Trang Gloves (Thailand) Public Company Limited, with a US agent in Tampa, Florida. The location where the testing occurred is not explicitly stated as a country or specific lab in this document. The data is retrospective in nature, as it's being presented to the FDA for review of a finished product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document describes performance testing of physical and chemical properties of gloves against established industry standards (e.g., ASTM, ISO). It does not involve human expert interpretation of medical images or clinical data to establish a "ground truth" in the way an AI medical device submission would. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment does not apply here. The "ground truth" for these tests is defined by the objective measurement criteria of the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set:
Not applicable, as this is objective device performance testing against established standards, not a review of clinical or imaging data requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, this is a 510(k) submission for a Class I medical device (nitrile exam gloves). MRMC studies are typically performed for high-risk diagnostic devices, particularly those involving AI, to assess the impact of the AI on human reader performance. This document details non-clinical laboratory testing of the glove's material properties and chemical resistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device. The "performance" described is the physical and chemical integrity of the glove itself.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on objective, standardized measurements according to established international and national standards for medical gloves, specifically:
- ASTM D 6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D 5151-2006 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D 6124-2006 (Reapproved 2001) (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D 6978 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
- ASTM D 412-2006a (reapproved 2013) (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
- ASTM D 573-2004 (Reapproved 2010), (Standard Test Method for Rubber-Deterioration in an Air Oven)
- ASTM D 3767-03 (Standard Practice for Rubber-Measurement of Dimensions)
- ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes)
- ISO 10993-5 (Biological evaluation of medical devices-Part5 Tests for in vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices-Part 10 Test for irritation and delayed-type hypersensitivity)
- ISO 10993-11 (Biological evaluation of medical devices-Part 11 Tests for systemic toxicity)
For the biocompatibility tests (cytotoxicity, irritation, systemic toxicity, sensitization), the ground truth is established through animal model studies, where specific observed reactions (or lack thereof) are assessed against established biological response criteria for those ISO standards.
8. The Sample Size for the Training Set:
Not applicable. This is a manufactured product (physical medical device), not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no machine learning model or training set is involved.
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