A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves.

Device Description

A powder-free surgeon's glove is a device made of synthetic elastomer that is intended to be worn by operating room personnel to protect a surgical wound from contamination.

AI/ML Overview

This document is an FDA 510(k) clearance letter for two types of surgical gloves (Flexylon Surgical Powder Free Gloves, Green and White variants). The core of this clearance is demonstrating substantial equivalence to a predicate device, which primarily relies on performance testing against established ASTM standards for chemotherapy drug permeation and dermatitis potential, rather than the kind of AI/machine learning study typically associated with your questions.

Therefore, many of the requested categories (e.g., "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," "Ground truth for the training set") are not applicable to this type of device clearance and the information provided in the document.

However, I can extract the relevant acceptance criteria and reported device performance from the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for chemotherapy drug permeation are implicitly defined by the results obtained when tested against the ASTM D6978 standard. For a glove to be considered "tested for use with chemotherapy drugs," the breakthrough detection time for each drug needs to be reported. There isn't a single universal "acceptance criterion" beyond demonstrating the performance as per the standard. For many drugs, a breakthrough time of ">240 minutes" indicates good resistance. For certain drugs, the breakthrough time is low, and the FDA has added warnings.

No.	Chemotherapy Drugs (Green Gloves)	Concentration	Breakthrough Detection Time in Minutes (Reported)	Acceptance Criteria (Implied)	Notes/Warnings
1.	Carmustine	3.3 mg/ml	7.7	N/A (performance reported)	Extremely low, do not use.
2.	Cisplatin	1.0 mg/ml	>240	N/A (performance reported)	Good resistance.
3.	Cyclophosphamide	20.0 mg/ml	>240	N/A (performance reported)	Good resistance.
4.	Dacarbazine	10.0 mg/ml	>240	N/A (performance reported)	Good resistance.
5.	Doxorubicin HCl	2.0 mg/ml	>240	N/A (performance reported)	Good resistance.
6.	Etoposide	20.0 mg/ml	>240	N/A (performance reported)	Good resistance.
7.	Fluorouracil	50.0 mg/ml	>240	N/A (performance reported)	Good resistance.
8.	Ifosfamide	50.0 mg/ml	>240	N/A (performance reported)	Good resistance.
9.	Methotrexate	25.0 mg/ml	>240	N/A (performance reported)	Good resistance.
10.	Mitomycin C	0.5 mg/ml	>240	N/A (performance reported)	Good resistance.
11.	Paclitaxel (Taxol)	6.0 mg/ml	>240	N/A (performance reported)	Good resistance.
12.	Thiotepa	10.0 mg/ml	11.4	N/A (performance reported)	Extremely low, do not use.
13.	Vincristine Sulfate	1.0 mg/ml	>240	N/A (performance reported)	Good resistance.

No.	Chemotherapy Drugs (White Gloves)	Concentration	Breakthrough Detection Time in Minutes (Reported)	Acceptance Criteria (Implied)	Notes/Warnings
1.	Carmustine	3.3 mg/ml	11.9	N/A (performance reported)	Extremely low, do not use.
2.	Cisplatin	1.0 mg/ml	>240	N/A (performance reported)	Good resistance.
3.	Cyclophosphamide	20.0 mg/ml	>240	N/A (performance reported)	Good resistance.
4.	Dacarbazine	10.0 mg/ml	>240	N/A (performance reported)	Good resistance.
...	(Additional 28 drugs for White Gloves)	...	>240 for most, 12.3 for Thiotepa	N/A (performance reported)	Good resistance for most. Thiotepa is extremely low, do not use.
12.	Thiotepa	10.0 mg/ml	12.3	N/A (performance reported)	Extremely low, do not use.

For the "Low Dermatitis Potential Claim," the acceptance criterion would be that the glove meets the requirements of ASTM D6355-07, which is "Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves." The document states the gloves were tested according to this standard, implying they met its criteria for a low dermatitis potential claim.

Study Proving Device Meets Acceptance Criteria:

The studies proving the device meets the acceptance criteria are referenced as:

ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
ASTM D6355-07, Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

These are standardized testing methods, not complex AI or clinical studies. The results of these tests are presented in the tables above.

Non-Applicable / Not Provided Information:

For the remaining points, the information is either not applicable to this type of device submission or not provided in the FDA clearance letter:

Sample sized used for the test set and the data provenance: Not explicitly stated in the document. ASTM standards typically specify sample sizes for testing. The data provenance would be laboratory testing results.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for permeation is determined by scientific measurement according to the ASTM D6978 standard, and for dermatitis potential by the ASTM D6355-07 standard. This does not involve expert consensus in the way an AI model might.
Adjudication method for the test set: Not applicable. Standardized laboratory testing methods are employed.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not relevant for glove testing. This is typically for diagnostic imaging devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/algorithm-based device.
The type of ground truth used: For chemotherapy permeation, the ground truth is the directly measured breakthrough time of the drug through the glove material. For dermatitis potential, the ground truth is determined by the results of human repeat insult patch testing as per ASTM D6355-07.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary

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August 18, 2023

Sentienx Sdn Bhd % David Lim Executive Director TG Medical USA (INC) 165 N. Aspen Ave. Azusa, California 91702

Re: K222993

Trade/Device Name: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs

Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: August 15, 2023 Received: August 15, 2023

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 (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,

Bifeng Qian -S

BiFeng Qian, M.D., Ph.D 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) K22993

Device Name

Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs

Indications for Use (Describe)

Chemotherapy Drugs Permeation

The following drugs have been tested with these gloves

No.	Chemotherapy Drugs	Concentration	Breakthrough Detection Time in Minutes
1.	Carmustine	3.3 mg/ml	7.7
2.	Cisplatin	1.0 mg/ml	>240
3.	Cyclophosphamide	20.0 mg/ml	>240
4.	Dacarbazine	10.0 mg/ml	>240
5.	Doxorubicin HCI	2.0 mg/ml	>240
6.	Etoposide	20.0 mg/ml	>240
7.	Fluorouracil	50.0 mg/ml	>240
8.	Ifosfamide	50.0 mg/ml	>240
9.	Methotrexate	25.0 mg/ml	>240
10.	Mitomycin C	0.5 mg/ml	>240
11.	Paclitaxel (Taxol)	6.0 mg/ml	>240
12.	Thiotepa	10.0 mg/ml	11.4
13.	Vincristine Sulfate	1.0 mg/ml	>240

Warning: The permeation times for Carmustine and Thiotena are extremely low with permeation times of 7,7 minutes and 11.4 minutes respectively. Do not use with Carmustine or Thiotepa.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Indications for Use

510(k) Number (if known) K22993

Device Name

Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs

Indications for Use (Describe)

Chemotherapy Drugs Permeation

The following drugs have been tested with these gloves

No.	Chemotherapy Drugs	Concentration	Breakthrough Detection Time in Minutes
1.	Carmustine	3.3 mg/ml	11.9
2.	Cisplatin	1.0 mg/ml	>240
3.	Cyclophosphamide	20.0 mg/ml	>240
4.	Dacarbazine	10.0 mg/ml	>240
5.	Doxorubicin HCI	2.0 mg/ml	>240
6.	Etoposide	20.0 mg/ml	>240
7.	Fluorouracil	50.0 mg/ml	>240
8.	Ifosfamide	50.0 mg/ml	>240
9.	Methotrexate	25.0 mg/ml	>240
10.	Mitomycin C	0.5 mg/ml	>240
11.	Paclitaxel (Taxol)	6.0 mg/ml	>240
12.	Thiotepa	10.0 mg/ml	12.3
13.	Vincristine Sulfate	1.0 mg/ml	>240
14.	Bleomycin Sulfate	15.0 mg/ml	>240
15.	Busulfan	6.0 mg/ml	>240
16.	Carboplatin	10.0 mg/ml	>240
17.	Cytarabine HCI	100.0 mg/ml	>240
18.	Cytovene	10.0 mg/ml	>240
19.	Daunorubicin HCI	5.0 mg/ml	>240
20.	Docetaxel	10.0 mg/ml	>240
21.	Epirubicin HCI	2.0 mg/ml	>240
22.	Fludarabine	25.0 mg/ml	>240
23.	Gemcitabine (Gemzar)	38.0 mg/ml	>240
24.	Idarubicin HCI	1.0 mg/ml	>240
25.	Irinotecan	20.0 mg/ml	>240
26.	Mechlorethamine HCI	1.0 mg/ml	>240
27.	Melphalan	5.0 mg/ml	>240
28.	Mitoxantrone	2.0 mg/ml	>240
29.	Oxaliplatin	5.0 mg/ml	>240
30.	Rituximab	10.0 mg/ml	>240
31.	Trisenox	1.0 mg/ml	>240
32.	Vinorelbine	10.0 mg/ml	>240

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Warning : The permeation times for Carmustine and Thiotepa are extremely low with permeation times of 11.9 minutes and 12.3 minutes respectively. Do not use with Carmustine or Thiotepa.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).