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

• K Number: K222714
• 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: 2022-10-07 ( 29 days)
• Product Code: LZA , LZC , OPJ , QDO
• Regulation Number: 880.6250
• Type: Special
• Panel: HO
• Reference & Predicate Devices: K213040

Intended Use

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:

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Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Test Methodology	Purpose	Acceptance Criteria	Results
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

Thickness (mm):
Finger: ≥0.05
Palm: ≥0.08 | Pass |
| ASTM D6319 (Physical Properties) | Physical Properties (Tensile Strength & Elongation) | Before Aging:
Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500%

After Aging:
Tensile Strength: ≥14MPa
Ultimate Elongation: ≥500% | Pass |
| ASTM D5151 | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Pass |
| ASTM D6124 | Powder Residue | Meet the requirements of ASTM D6124 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.
• 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.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.