A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Description

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

AI/ML Overview

This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim." The core of the submission revolves around demonstrating the glove's resistance to permeation by chemotherapy drugs and Fentanyl.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nitrile Powder Free Examination Glove's resistance to chemotherapy drugs and Fentanyl permeation are based on the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is the "Minimum breakthrough Detection Time (min)" for each chemical.

No	Test Chemotherapy Drug	Concentration (mg/ml)	Acceptance Criteria (Implicit from context: generally, higher is better, and values over 240 mins are good, though specific pass/fail thresholds are not explicitly stated as 'acceptance criteria' in the common sense, rather the demonstration of resistance)	Reported Device Performance (Minimum breakthrough Detection Time (min))
1	Amethopterin	25	Resistance to permeation	>240
2	Bleomycin Sulfate	15	Resistance to permeation	>240
3	Busulfan	6	Resistance to permeation	>240
4	Carboplatin	10	Resistance to permeation	>240
5	Carmustine	3.3	Resistance to permeation (Note: Explicit warning given due to low permeation time)	11.0
6	Cisplatin	1	Resistance to permeation	>240
7	Cyclophosphamide	20	Resistance to permeation	>240
8	Cytarabine	100	Resistance to permeation	>240
9	Dacarbazine	10	Resistance to permeation	>240
10	Docetaxel	10	Resistance to permeation	>240
11	Doxorubicin HCl	2	Resistance to permeation	>240
12	Ellence	2	Resistance to permeation	>240
13	Etoposide	20	Resistance to permeation	>240
14	Fludarabine	25	Resistance to permeation	>240
15	Fluorouracil	50	Resistance to permeation	>240
16	Gemcitabine	38	Resistance to permeation	>240
17	Idarubicin	1	Resistance to permeation	>240
18	Ifosfamide	50	Resistance to permeation	>240
19	Irinotecan	20	Resistance to permeation	>240
20	Mechlorethamine	1	Resistance to permeation	>240
21	Melphalan	5	Resistance to permeation	>240
22	Methotrexate	25	Resistance to permeation	>240
23	Mitomycin C	0.5	Resistance to permeation	>240
24	Mitoxantrone	2	Resistance to permeation	>240
25	Oxaliplatin	5	Resistance to permeation	>240
26	Paclitaxel	6	Resistance to permeation	>240
27	Rituximab	10	Resistance to permeation	>240
28	Thiotepa	10	Resistance to permeation (Note: Explicit caution given due to low permeation time)	39
29	Topotecan	1	Resistance to permeation	>240
30	Trisenox	1	Resistance to permeation	>240
31	Vincristine Sulfate	1	Resistance to permeation	>240
32	Vinorelbine	10	Resistance to permeation	>240
33	Fentanyl Citrate	100 mcg/2ml	Resistance to permeation	>240

The Study that Proves the Device Meets the Criteria:

The study referenced is the testing performed "as per ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard is a recognized methodology for evaluating the integrity of medical gloves when exposed to hazardous chemicals. The table provided directly presents the results of this testing, showing the breakthrough detection times for each specified drug and Fentanyl Citrate.

Remaining Information Not Present in the Document:

The provided document (an FDA 510(k) clearance letter and Indications for Use statement) does not contain the detailed technical information required to answer the following questions:

Sample size used for the test set and the data provenance: Not mentioned. The document only presents chemical permeation test results.
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 performance test for a glove, not an AI or diagnostic device requiring expert interpretation of results for "ground truth." The "ground truth" here is the direct measurement of chemical breakthrough time.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus building among human readers for diagnostic interpretation, which is not relevant for a glove permeation test.
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 for AI-assisted diagnostic devices, not protective equipment like gloves.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by the direct measurement of chemical permeation through the glove material according to the ASTM D6978-05 standard. It is a direct physical measurement.
The sample size for the training set: Not applicable. This refers to the training of machine learning models, which is irrelevant for a glove permeation test.
How the ground truth for the training set was established: Not applicable. This refers to the training of machine learning models.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

February 24, 2021

GMP Medicare SDN BHD % David Lim Executive Director TG Medical USA (INC) 165 N. Aspen Avenue Azusa, California 91702

Re: K202003

Trade/Device Name: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO Dated: January 15, 2021 Received: January 25, 2021

Dear David Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202003

Device Name

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

No	Test Chemotherapy Drug	Concentration (mg/ml)	Minimum breakthrough Detection Time (min)
1	Amethopterin	25	>240
2	Bleomycin Sulfate	15	>240
3	Busulfan	6	>240
4	Carboplatin	10	>240
5	Carmustine	3.3	11.0
6	Cisplatin	1	>240
7	Cyclophosphamide	20	>240
8	Cytarabine	100	>240
9	Dacarbazine	10	>240
10	Docetaxel	10	>240
11	Doxorubicin HCl	2	>240
12	Ellence	2	>240
13	Etoposide	20	>240
14	Fludarabine	25	>240
15	Fluorouracil	50	>240
16	Gemcitabine	38	>240
17	Idarubicin	1	>240
18	Ifosfamide	50	>240
19	Irinotecan	20	>240
20	Mechlorethamine	1	>240
21	Melphalan	5	>240
22	Methotrexate	25	>240
23	Mitomycin C	0.5	>240
24	Mitoxantrone	2	>240
25	Oxaliplatin	5	>240
26	Paclitaxel	6	>240
27	Rituximab	10	>240
28	Thiotepa	10	39
29	Topotecan	1	>240
30	Trisenox	1	>240
31	Vincristine Sulfate	1	>240
32	Vinorelbine	10	>240
33	Fentanyl Citrate	100 mcg/2ml	>240

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Please note that Carmustine and Thiotepa have extremely low permeation times of 11 minutes respectively Warning: do not use Carmustine.

CAUTION: Testing showed an average breakthrough time of 39 minutes with Thiotepa

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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.