Search Results

The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows:

Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 17.2 min. Cisplatin 1.0 mg/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Cytarabine HCI 100 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Daunorubicin 5 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Gemcitabine 38 mg/ml>240 min. Idarubicin 1 mg/ml >240 min. Ifosfamide 50.0 mg/ml >240 min. Irinotecan 20.0 mg/ml >240 min. Mechlorethamine HCI 1.0 mg/ml>240 min. Melphalan 5 mg/ml >240 min. Methotrexate 25 mg/ml >240 min. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 13.9min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

Warning: Do not use with Carmustine and Thiotepa.

The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The tested chemotherapy drug are as follows: Bleomycin Sulfate 15 mg/ml >240 min. Busulfan 6 mg/ml >240 min. Carboplatin 10 mg/ml >240 min. Carmustine (BCNU) 3.3 mg/ml 65.3 min. Cisplatin 1.0 mg/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Cytarabine HCI 100 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Daunorubicin 5 mg/mL >240 min. Docetaxel 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min. Epirubicin HCl 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fludarabine 25.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Gemcitabine 38 mg/ml>240 min. Idarubicin 1 mg/ml >240 min. Ifosfamide 50.0 mg/ml >240 min. Irinotecan 20.0 mg/ml >240 min. Mechlorethamine HCI 1.0 mg/ml>240 min. Melphalan 5 mg/ml >240 min. Methotrexate 25 mg/ml >240 min. Mitromvcin C. 0.5 mg/ml >240 Mitoxantrone 2.0 mg/ml >240 min. Paclitaxel (Taxol) 6.0 mg/ml >240 min. Rituximab 10.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 58.3min. Trisenox 1.0 mg/ml >240 min. Vincristine Sulfate 1.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes

Warning: Do not use with Carmustine and Thiotepa.

The Nitrile Patient Examination Gloves Black Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The tested chemotherapy drug are as follows: Carmustine (BCNU) 3.3 mg/ml 49.2 min. Cisplatin 1.0 mq/ml >240 min. Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. Dacarbazine (DTIC)10.0 mg/ml >240 min. Doxorubicin HCI 2.0 mg/ml >240 min. Etoposide (Toposar) 20.0 mg/ml >240 min. Fluorouracil 50.0 mg/ml >240 min. Fentanyl Citrate 100mcg/2ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 min. Thiotepa 10.0 mg/ml 87.1min.

Warning: Do not use with Carmustine and Thiotepa.

Device Description

Powder-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, extra-small, medium, large, extralarge, extra-extra-large. Three colors are available for all size, includes blue, blue violet and black.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

AI/ML Overview

This document describes the premarket notification (510(k)) for Nitrile Patient Examination Gloves, with specific testing for chemotherapy drug permeation. Based on the provided text, the "device" is a physical product (gloves) and not an AI/software device, therefore many of the requested criteria (MRMC study, AI assistance, ground truth establishment, training set, etc.) are not applicable.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based entirely on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Test Methodology	Purpose	Acceptance Criteria
ASTM D6319 (Physical Dimensions)	Physical Dimensions Test	Length:
Extra-Small: ≥ 220mm
Small: ≥ 220mm
Medium: ≥ 230mm
Large: ≥ 230mm
Extra-Large: ≥ 230mm
Extra-Extra-Large: ≥ 230mm

Width:
Extra-Small: 70±10mm
Small: 80±10mm
Medium: 95±10mm
Large: 110±10mm
Extra-Large: 120±10mm
Extra-Extra-Large: ≥120mm

Busulfan 6 mg/ml: >240 min.
Carboplatin 10 mg/ml: >240 min.
Carmustine (BCNU) 3.3 mg/ml: 17.2 min.
Cisplatin 1.0 mg/ml: >240 min.
Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 min.
Cytarabine HCI 100 mg/ml: >240 min.
Dacarbazine (DTIC)10.0 mg/ml: >240 min.
Daunorubicin 5 mg/mL: >240 min.
Docetaxel 10.0 mg/ml: >240 min
Doxorubicin HCI 2.0 mg/ml: >240 min.
Epirubicin HCI 2.0 mg/ml: >240 min.
Etoposide (Toposar) 20.0 mg/ml: >240 min.
Fludarabine 25.0 mg/ml: >240 min.
Fluorouracil 50.0 mg/ml: >240 min.
Gemcitabine 38 mg/ml: >240 min.
Idarubicin 1 mg/ml: >240 min.
Ifosfamide 50.0 mg/ml: >240 min.
Irinotecan 20.0 mg/ml: >240 min.
Mechlorethamine HCI 1.0 mg/ml: >240 min.
Melphalan 5 mg/ml: >240 min.
Methotrexate 25 mg/ml: >240 min.
Mitomycin C. 0.5 mg/ml: >240
Mitoxantrone 2.0 mg/ml: >240 min.
Paclitaxel (Taxol) 6.0 mg/ml: >240 min.
Rituximab 10.0 mg/ml: >240 min.
Thiotepa 10.0 mg/ml: 13.9 min.
Trisenox 1.0 mg/ml: >240 min.
Vincristine Sulfate 1.0 mg/ml: >240 min.
Fentanyl Citrate 100mcg/2ml: >240 minutes
Warning: Do not use with Carmustine and Thiotepa.

Nitrile Patient Examination Gloves Blue Violet (Tested Drugs & Permeation Time):

Bleomycin Sulfate 15 mg/ml: >240 min.
Busulfan 6 mg/ml: >240 min.
Carboplatin 10 mg/ml: >240 min.
Carmustine (BCNU) 3.3 mg/ml: 65.3 min.
Cisplatin 1.0 mg/ml: >240 min.
Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 min.
Cytarabine HCI 100 mg/ml: >240 min.
Dacarbazine (DTIC)10.0 mg/ml: >240 min.
Daunorubicin 5 mg/mL: >240 min.
Docetaxel 10.0 mg/ml: >240 min
Doxorubicin HCI 2.0 mg/ml: >240 min.
Epirubicin HCl 2.0 mg/ml: >240 min.
Etoposide (Toposar) 20.0 mg/ml: >240 min.
Fludarabine 25.0 mg/ml: >240 min.
Fluorouracil 50.0 mg/ml: >240 min.
Gemcitabine 38 mg/ml: >240 min.
Idarubicin 1 mg/ml: >240 min.
Ifosfamide 50.0 mg/ml: >240 min.
Irinotecan 20.0 mg/ml: >240 min.
Mechlorethamine HCI 1.0 mg/ml: >240 min.
Melphalan 5 mg/ml: >240 min.
Methotrexate 25 mg/ml: >240 min.
Mitomycin C. 0.5 mg/ml: >240
Mitoxantrone 2.0 mg/ml: >240 min.
Paclitaxel (Taxol) 6.0 mg/ml: >240 min.
Rituximab 10.0 mg/ml: >240 min.
Thiotepa 10.0 mg/ml: 58.3 min.
Trisenox 1.0 mg/ml: >240 min.
Vincristine Sulfate 1.0 mg/ml: >240 min.
Fentanyl Citrate 100mcg/2ml: >240 minutes
Warning: Do not use with Carmustine and Thiotepa.

Nitrile Patient Examination Gloves Black (Tested Drugs & Permeation Time):

Carmustine (BCNU) 3.3 mg/ml: 49.2 min.
Cisplatin 1.0 mg/ml: >240 min.
Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 min.
Dacarbazine (DTIC)10.0 mg/ml: >240 min.
Doxorubicin HCI 2.0 mg/ml: >240 min.
Etoposide (Toposar) 20.0 mg/ml: >240 min.
Fluorouracil 50.0 mg/ml: >240 min.
Fentanyl Citrate 100mcg/2ml: >240 minutes
Paclitaxel (Taxol) 6.0 mg/ml: >240 min.
Thiotepa 10.0 mg/ml: 87.1 min.
Warning: Do not use with Carmustine and Thiotepa. | The permeation resistance was tested and the break-through times for each listed chemotherapy drug are reported as the "Results" for each glove colored variation. The tables within the document (pages 8-10, and 12-14) explicitly list these times. The general acceptance criterion for these types of tests is generally that the glove provides a minimum specified protection time (e.g., >240 minutes for many drugs, unless a shorter warning is given), and these results are directly reported. The "Pass" in the summary table (page 18) indicates overall compliance with the standard for specific tests. |

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample size (number of gloves) used for each individual test (e.g., how many gloves were tested for permeation by each drug). It generally refers to "tests" being performed.
Data Provenance: The tests were conducted according to established ASTM and ISO standards for medical devices. The manufacturer is "Guang Dong Kingfa Sci. & Tech.Co., Ltd." in China. The data itself is from laboratory testing, not from patient data. The studies are non-clinical (in-vitro, physical/chemical tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical device (medical gloves) and not an AI/software device that requires expert human interpretation or consensus for ground truth establishment. The "ground truth" here is the measured performance of the glove against established physical and chemical standards (e.g., tensile strength, pinhole presence, chemical permeation time).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. As this is not an AI/software device involving human-in-the-loop decisions or human interpretive tasks, no adjudication method for ground truth was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is a physical device, not an AI/software system for medical image analysis or diagnosis.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical device, not an algorithm. The device's performance is standalone in that its properties (e.g., permeation resistance) are directly measured.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for these tests is defined by adherence to published international standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11, and particularly ASTM D6978-05 for chemotherapy drug permeation). For the chemotherapy drug permeation specifically, the ground truth is the experimentally determined breakthrough time of the specific chemicals through the glove material under controlled laboratory conditions, as specified by the standard.

8. The sample size for the training set:

Not Applicable. This is a physical device; there is no 'training set' in the machine learning sense. The manufacturing process and quality control would involve internal testing, but this is not referred to as a "training set" in the context of typical AI/ML device submissions.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI/ML model, this point does not apply.

Ask a Question

Ask a specific question about this device

K Number

K213040

Device Name

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

Manufacturer

Guang Dong Kingfa Sci. & Tech.Co., Ltd.

Date Cleared

2022-04-27

(217 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K211220

Intended Use

The blue colored nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Bleomycin Sulfate 15 mg/ml >240 min., Carboplatin 10 mg/ml >240 min., Carmustine (BCNU) 3.3 mg/ml 17.2 min., Cisplatin 1.0 mg/ml >240 min., Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min., Cytarabine HCI 100 mg/ml >240 min., Dacarbazine (DTIC)10.0 mg/ml >240 min., Daunorubicin 5.0 mg/ml >240 min., Docetaxel 10.0 mg/ml >240 min, Doxorubicin HCI 2.0 mg/ml >240 min., Etoposide (Toposar) 20.0 mg/ml >240 min., Fluorouracil 50.0 mg/ml >240 min., Gemcitabine 38 mg/ml>240 min., Idarubicin 1 mg/ml >240 min., Ifosfamide 50.0 mg/ml >240 min., Irinotecan 20.0 mg/ml >240 min., Mechlorethamine HCI 1.0 mg/ml>240 min., Melphalan 5 mg/ml >240 min., Methotrexate 25 mg/ml >240 min., Mitromycin C. 0.5 mg/ml >240, Mitoxantrone 2.0 mg/ml >240 min., Paclitaxel (Taxol) 6.0 mg/ml >240 min., Thiotepa 10.0 mg/ml 13.9 min., Vincristine Sulfate 1.0 mg/ml >240 min. Warning: Do not use with Carmustine and Thiotepa.

The nitrile examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device. The Nitrile Patient Examination Gloves Blue Violet Colored were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The tested chemotherapy drug are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 min., Cisplatin 1.0 mg/ml >240 min., Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min., Dacarbazine (DTIC)10.0 mg/ml >240 min., Doxorubicin HCI 2.0 mg/ml >240 min., Etoposide (Toposar) 20.0 mg/ml >240 min., Fluorouracil 50.0 mg/ml >240 min., Methotrexate 25 mg/ml >240 min., Paclitaxel (Taxol) 6.0 mg/ml >240 min., Thiotepa 10.0 mg/ml 58.3 min. Warning: Do not use with Carmustine and Thiotepa.

Device Description

Power-Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in six sizes, x-small (6.5"), small (7"), medium (8"), large (8.5"), X-large (9"), XXL (9.5"). Three colors are available for all size, includes blue, blue violet and black. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

AI/ML Overview

The provided document describes the acceptance criteria and study results for "Nitrile Patient Examination Gloves" (various colors) tested for use with chemotherapy drugs or Fentanyl Citrate. This is a medical device, and the evaluation is based on non-clinical performance standards rather than an AI/ML algorithm.

Therefore, many of the requested fields related to AI/ML studies (sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, ground truth for training set, training set size) are not applicable to this submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Item	Methodology / Standard	Acceptance Criteria	Reported Device Performance
Physical Dimensions
Palm width	ASTM D3767-03(2020)	XS (70±10mm)
S (80±10mm)
M (95±10mm)
L (110±10mm)
XL (120±10mm)
XXL (≥ 120mm)	Pass
Length	ASTM D3767-03(2020)	XS (220mm min)
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min)
XXL (230mm min)	Pass
Thickness	ASTM D3767-03(2020)	Finger: 0.11mm
Palm: 0.05mm	Pass
Integrity
Freedom from holes	ASTM D5151-19	Freedom free hole
AQL 2.5	Pass
Physical Properties (before aging)
Tensile Strength	ASTM D412-16	≥ 14Mpa	Pass
Ultimate Elongation	ASTM D412-16	≥ 500%	Pass
Physical Properties (after aging)
Tensile Strength	ASTM D573-04(2019)	≥ 14Mpa	Pass
Ultimate Elongation	ASTM D573-04(2019)	≥ 400%	Pass
Chemical Content
Residual Powder Content	ASTM D6124-06(2017)	≤2mg per glove	Pass
Biocompatibility
Cytotoxicity	ISO 10993-5	Non-cytotoxic	Under conditions of the study, device extract is cytotoxic.
Acute Systemic Toxicity	ISO 10993-11	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
Irritation	ISO 10993-10	Non-irritating	Under the conditions of the study, not an irritant/ Pass
Sensitization	ISO 10993-10	Non-sensitizing	Under conditions of the study, not a sensitizer./ Pass
Chemotherapy Drug Permeation	ASTM D6978-05 (Reapproved 2019)	Min. permeation breakthrough time as specified for each drug	Achieved or exceeded specified times for individual drugs (see detailed lists in pages 2, 4, 5, 7, 8, 11, 12).
Fentanyl Citrate Permeation	ASTM D6978-05 (Reapproved 2019)	Min. permeation breakthrough time as specified (e.g., >240 min)	Achieved >240 minutes for Fentanyl Citrate (see detailed lists in pages 5, 8, 12).

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test, but standard ASTM and ISO methods generally specify sample sizes. For example, AQL 2.5 for "freedom from holes" implies a sampling plan. Since these are performance tests on manufactured goods, the "test set" would be a batch or set of gloves sampled from production.
Data Provenance: The document does not specify a country of origin for the testing data. The studies are described as "Non clinical tests" performed according to established international standards (ASTM, ISO). They are prospective in the sense that they are performed on the device to be marketed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the "ground truth" for these tests is defined by objective physical and chemical measurements according to standardized protocols (ASTM, ISO), not expert interpretation.

4. Adjudication method for the test set

Not applicable, as the evaluation is based on objective measurements against defined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.

7. The type of ground truth used

The "ground truth" for these tests is the direct measurement of physical properties (e.g., dimensions, tensile strength, elongation), chemical properties (e.g., residual powder content), and barrier properties (permeation breakthrough time for chemotherapy drugs and Fentanyl Citrate) against established, objective industry standards (ASTM, ISO). For biocompatibility, it's the observed biological response to the glove material under controlled test conditions.

8. The sample size for the training set

Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.

9. How the ground truth for the training set was established

Not applicable. This is a submission for physical medical gloves, not an AI/ML-driven device.

Ask a Question

Ask a specific question about this device

K Number

K203593

Device Name

Patient Examination Gloves

Manufacturer

Guang Dong Kingfa SCI. & TECH.CO., LTD.

Date Cleared

2021-03-19

(100 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K181106

Intended Use

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Description

The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.

AI/ML Overview

This is a 510(k) premarket notification for nitrile examination gloves, not an AI/ML medical device. Therefore, the request for acceptance criteria and study details related to AI/ML performance metrics (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable.

The document assesses the substantial equivalence of the proposed device (Nitrile Examination Gloves) to a predicate device (Powder Free Nitrile Patient Examination Gloves, Blue Color) based on non-clinical testing and comparison of technological characteristics.

Here’s a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of the proposed device with a predicate device, referencing ASTM standards for acceptance criteria. The performance of the proposed device is stated as meeting these requirements.

Item	Acceptance Criteria (typically from ASTM D6319-19)	Reported Device Performance (K203593)
Freedom from holes	Meets requirements of ASTM D6319-19	Meets requirements of ASTM D6319-19
Physical Properties (before aging)	Meets requirements of ASTM D6319-19	Meets requirements of ASTM D6319-19: Tensile Strength: ≥14 MPa, Elongation: ≥500%
Physical Properties (after aging)	Meets requirements of ASTM D6319-19	Meets requirements of ASTM D6319-19
Powder residual

Ask a Question

Ask a specific question about this device

Page 1 of 1