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 Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL
Note that Carmustine(BCNU) and Thiotepa have low permeation times.

Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL

Device Description

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs.

AI/ML Overview

This document describes a 510(k) premarket notification for a non-sterile, powder-free nitrile examination glove. It focuses on demonstrating substantial equivalence to a predicate device. The information provided is primarily related to the physical and chemical properties of the gloves, and their performance against established ASTM and ISO standards for medical gloves, rather than a diagnostic AI device requiring a clinical study with ground truth.

Given the nature of the device (medical gloves), the request for acceptance criteria and a study proving device meets acceptance criteria in the context of an AI device with ground truth, multi-reader studies, and training sets is not directly applicable. However, I can extract and present the relevant information from the document as it pertains to the performance criteria and testing used for these gloves.

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

The document provides a comparison table between the predicate device (K083755) and the subject device (K182241) against various technical characteristics and standards. It implicitly uses the standards as acceptance criteria.

Technological Characteristic	Standard (Acceptance Criteria)	Reported Subject Device Performance (K182241)
Indications for Use	(As described in regulatory text)	"Nearly Identical" to predicate
Dimensions: overall length	Minimum 230 mm (ASTM-D 6319)	238 mm (for all 3 measurements provided)
Dimensions: width (mean)	110 ± 10 mm (ASTM-D 6319)	Size Large: 114 mm, 115 mm, 114 mm
Dimensions: palm and finger thickness	Minimum 0.05 mm (ASTM-D 6319)	Palm: 0.07 mm, 0.07 mm, 0.07 mm; Finger: 0.08 mm, 0.08 mm, 0.09 mm
Tensile strength: before and after aging	Greater than 14 MPa (ASTM-D 6319)	Before: 35 MPa, 33 MPa, 35 MPa; After: 31 MPa, 32 MPa, 34 MPa
Ultimate elongation: before and after aging	Greater than 500% Before, 400% After (ASTM-D 6319)	Before: 538%, 534%, 535%; After: 518%, 493%, 503%
Freedom from holes: pinholes AQL 2.5	Inspection G1, AQL 2.5 (7 Accept, 8 Reject) (ASTM-D 6319)	0, 2, 0 (number of holes found, all within AQL)
Powder Free Residue	0.5 mg/glove (ASTM-D 6319)	0.8 mg/glove, 0.8 mg/glove
*Biocompatibility: In vitro* cytotoxicity**	ISO 10993-5 (No specific numerical criterion, qualitative result expected)	Device extract found cytotoxic (further evaluated by ISO 10993-11)
Biocompatibility: Systemic toxicity	ISO 10993-11 (No specific numerical criterion, qualitative result expected)	Device extracts did not elicit a systemic response in the animal model.
Biocompatibility: Primary Skin Irritation	ISO 10993-10 (No specific numerical criterion, qualitative result expected)	Polar and non-polar device extracts found not to be an irritant.
Biocompatibility: Sensitization	Guinea Pig Sensitization (ISO 10993-10) (No specific numerical criterion, qualitative result expected)	Polar and non-polar device extracts found not to be sensitizers.
Chemotherapy Drug Permeation	Permeation resistance to specified chemotherapy drugs (ASTM D6978)	Tested against 11 chemotherapy drugs (including Carmustine and Thiotepa with low permeation times), and Fentanyl. Specific permeation times are not provided in this summary, but the device is "Tested for use with Chemotherapy Drugs," implying it met relevant performance for these.

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

The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for dimensions, tensile strength, or holes). It refers to standards like ASTM D6319 and ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes), which would dictate the sample sizes and sampling methods used for such material tests.

The data provenance is from non-clinical tests performed to demonstrate that the proposed device met all design specifications. The country of origin of the data is not explicitly stated, but the manufacturer is Sri Trang Gloves (Thailand) Co., LTD. Given the nature of manufacturing quality control and standard testing, this data would be considered prospective for the purpose of validating the product before its market release.

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

This question is not applicable to the device described. The device is a medical glove, and its performance is evaluated against engineering and biological compatibility standards, not by experts establishing a "ground truth" for a diagnostic task. The tests are objective measurements and standardized biological assays.

4. Adjudication method for the test set

Not applicable. Performance is measured against objective standards, not subjective assessments requiring adjudication.

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 device is a medical glove, not an AI-powered diagnostic tool.

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

Not applicable. This device is a medical glove, not an algorithm.

7. The type of ground truth used

For the physical and chemical properties, the "ground truth" is defined by the specific parameters and limits set forth in the referenced ASTM and ISO standards (e.g., minimum length, minimum tensile strength, maximum number of holes at a given AQL). For biocompatibility, the "ground truth" is the qualitative assessment of biological response (e.g., non-irritant, non-sensitizer, no systemic toxicity) in accordance with ISO 10993 series, using defined animal models and in vitro tests.

8. The sample size for the training set

Not applicable. This device is a medical glove, not an AI model that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

March 11, 2019

Sri Trang Gloves (Thailand) Co., LTD % M. Jordan Smith Quality Assurance and Regulatory Affairs Leader Sri Trang USA DBA Ventyv 5401 West Kennedy Boulevard, Suite 760 Tampa, Florida 33609-2447

Re: K182241

Trade/Device Name: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA,LZC, QDO Dated: February 14, 2019 Received: February 14, 2019

Dear M. Jordan Smith:

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 avare 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.

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elizabeth F. Claverie -S

Digitally signed by Elizabeth F. Claverie -S Date: 2019.03.11 00:18:52 -04'00'

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182241

Device Name

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs

Indications for Use (Describe)

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 Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL
Note that Carmustine(BCNU) and Thiotepa have low permeation times.

Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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."

{3}------------------------------------------------

510(k) Summary [As Required by 21 section 807.92 (c)] K182241

Summary prepared: February 27, 2019

Sri Trang Gloves (Thailand) CO., LTD 10 Soi 10 Phetkasem Rd. Hatyai Songkhla. Thailand 90110 Phone: (+66) 74 344 663 Fax: (+66) 74 344 677 Contact Person - Mr. Anan Pruksanusak, Managing Director

Official Correspondent: Sri Trang USA DBA Ventyv™ 5401 West Kennedy Boulevard, Suite 760 Tampa, Florida 33609-2447 Phone: +1 (813) 606-4301 Fax: +1 (813) 606-4314 Contact person - Mr. M. Jordan Smith, Quality Assurance and Regulatory Affairs Leader

Device Trade or Proprietary Name - Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs

Device Common or Usual Name - Examination glove

Device Classification Name - Nitrile Patient Examination Glove (21 CFR 880.6250)

Device Product Codes - LZA, LZC, QDO

Device Class - Class I

Description of the Device - Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs.

{4}------------------------------------------------

Intended Use of the Device – 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.

	TECHNOLOGICALCHARACTERISTICS	STANDARD	PREDICATEDEVICEK083755	SUBJECTDEVICE K182241
Indications for Use	N/A	This device is adisposable deviceintended for medicalpurpose that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer.The chemotherapydrugs tested are asfollows:AmethopterinHydrate(Methotrexate),Cisplatin,Cyclphoshamide(Cytoxan),Dacarbazine (DTIC),DoxorubicinHydrochloride,Etoposide (Toposar),5-Fluoruracil,Paclitazel (Taxol),and VincristineSulfate	This device is adisposable deviceintended for medicalpurpose that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer.The testedchemotherapy drugsare as follows:Carmustine (BCNU)Cisplatin,Cyclophosphamide,Dacarbzine (DTIC),DoxorubicinHydrochloride,Etoposide (Toposar),Fluorouracil,Methotrexate,Paclitaxel (Taxol),Thiotepa,Vincristine SulfateNote Carmustine(BCNU) andThiotepa have lowpermeation timesFentanyl tested asfollows:Fentanyl Citrate	Nearly Identical
Dimensions: overalllength	Minimum 230mm	244 mm	238 mm238 mm	Identical
	ASTM-D6319	242 mm242 mm	238 mm
Dimensions: width(mean)	110 $ \pm $ 10 mmASTM-D6319	Size Large113 mm114 mm114 mm	Size Large114 mm115 mm114 mm	Identical
Dimensions: palm andfinger thickness	Minimum0.05 mmASTM-D6319	Palm0.06 mm0.07 mm0.07 mmFinger0.09 mm0.07 mm0.08 mm	Palm0.07 mm0.07 mm0.07 mmFinger0.08 mm0.08 mm0.09 mm	Identical
Tensile strength: beforeand after aging	Greater than14 MPaASTM-D6319	Before40 MPa40 MPa41 MPaAfter39 MPa40 MPa41 MPa	Before35 MPa33 MPa35 MPaAfter31 MPa32 MPa34 MPa	Identical
Ultimate elongation:before and after aging	Greater than500% Before,400% AfterASTM-D6319	Before564%584%580%After580%580%616%	Before538%534%535%After518%493%503%	Identical
Freedom from holes:pinholes AQL 2.5	InspectionG1, AQL 2.57 Accept8 RejectASTM-D6319	323	020	Identical
	ASTM-D	0.5 mg/glove	0.7 mg/glove
Powder Free Residue	6319	0.3 mg/glove0.2 mg/glove	0.8 mg/glove0.8 mg/glove	Identical
	ISO 10993-5In vitrocytotoxicity	N/A	Under the conditionsof the study, thedevice extract wasfound to becytotoxic andtherefore the deviceextracts wereevaluated by ISO10993-11 - Test forsystemic toxicity.From the AcuteSystemic Toxicitydevice extracts, thedevice extracts didnot elicit a systemicresponse in theanimal model.	Identical
	ISO 10993-11Tests forsystemictoxicity
Biocompatibility	ISO 10993-10Primary SkinIrritation inRabbits	Under the conditionsof the study, the polarand non-polar deviceextracts were foundnot to be an irritant tothe animal model.	Under the conditionsof the study, thepolar and non-polardevice extracts werefound not to be anirritant to the animalmodel.	Same
	Guinea PigSensitization	Under the conditionsof the study, the polarand non-polar deviceextracts were foundnot to be sensitizersto the animal model.	Under the conditionsof the study, thepolar and non-polardevice extracts werefound not to besensitizers to theanimal model.	Same

Technological Characteristics Comparison Table –

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

Summary of Non-Clinical Performance Testing - Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:

. ASTM D412-2006a (reapproved 2013) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration . in an Air Oven
ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ●
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in . Medical Gloves
ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on ● Medical Gloves
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical . Application
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo ● cytotoxicity
ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and . delaved-type hypersensitivity
ISO 10993-10 Biological evaluation of medical devices-Part 11 Tests for systemic toxicity

Conclusion - The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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.