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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes

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 powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.

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

The provided document describes the acceptance criteria and the study conducted for "Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs" and "Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs".

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D5151	Water Leak Test	The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151.	pass
ASTM D3767	Dimension	The actual measured dimension of the gloves shall meet the stated tolerance in Table 2 of the ASTM D 6319-19.	pass
Before aging ASTM D412, After aging ASTM D573	Physical Properties (Tensile Strength, Ultimate Elongation)	Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM 6319-19 (Tensile Strength: Before Aging ≥ 14 MPa, min.; After Aging ≥ 14 MPa, min. Elongation: Before Aging 500%, min.; After Aging 400%, min.).	pass
ASTM D6124	Residual Powder Content	The powder residue content shall be not more than 2mg per gloves.	pass
ASTM D6978-05	Chemotherapy Drugs Permeation Time	Carmustine (BCNU) 3.3 mg/ml: 65.3 minutes Cisplatin 1.0 mg/ml: >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 minutes Dacarbazine (DTIC)10.0 mg/ml: >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml: >240 minutes Etoposide (Toposar) 20.0 mg/ml: >240 minutes Fluorouracil 50.0 mg/ml: >240 minutes Paclitaxel (Taxol) 6.0 mg/ml: >240 minutes Thiotepa 10.0 mg/ml: 58.3 minutes	pass
ISO 10993-10:2010	Skin Irritation	non-irritating	pass
ISO 10993-10:2010	Skin Sensitization	non-sensitizing	pass
ISO 10993-11:2017	Acute Systemic Toxicity	No acute system toxicity	pass

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

The document does not specify the exact sample sizes (number of gloves or individual tests) used for each non-clinical test. It only states that "Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications."

The data provenance is from non-clinical laboratory testing conducted to established international and ASTM standards. The country of origin of the data is not explicitly stated for each test, but the devices are manufactured by GUANGDONG KINGFA SCI. & TECH.CO., LTD. in Qingyuan, Guangdong, China. The testing appears to be prospective as it was performed to verify the device's compliance.

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

This information is not applicable. The study involves non-clinical performance testing of medical devices (gloves), not a diagnostic algorithm or human-readable data necessitating expert ground truth establishment. The "ground truth" here is determined by the objective measurements and adherence to the specified ASTM and ISO standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data. For non-clinical device testing, the results are objectively measured against predefined criteria.

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

There was no MRMC comparative effectiveness study done. This study is for medical gloves, which are physical devices, not an AI or imaging diagnostic tool that would involve human readers.

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

This information is not applicable. This study concerns a physical medical device (gloves), not an algorithm or AI.

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

The "ground truth" for this non-clinical testing is based on objective measurements and adherence to established international standards such as ASTM D6319-19, ASTM D6978-05, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the acceptable physical properties, chemical permeation resistance, and biocompatibility of the gloves.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not a machine learning or AI algorithm development study.

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

This information is not applicable, as there is no training set for this type of device testing.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 22, 2021

Guangdong Kingfa Sci. & Tech. Co., Ltd. Xiaoge Yu Manager No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China

Re: K211220

Trade/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 Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: April 16, 2021 Received: April 23, 2021

Dear Xiaoge Yu:

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.

Clarence W. Murray, III, PhD 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) K211220

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

Indications for Use (Describe)

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

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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510(k) Summary K211220

I. Submitter

GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28 Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China

Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn

Preparation date: April. 03, 2021

US Agent

Jeff Zhang Ucl-Reg Service Inc 602 Rockwood Rd Wilmington, DE US 19802 Phone: 516 2311209 Email: us-agent@glomed-info.com

II. Proposed Device

Device Trade Name	Nitrile Patient Examination Gloves Blue Tested For Use WithChemotherapy DrugsNitrile Patient Examination Gloves Blue Violet Tested For UseWith Chemotherapy Drugs
Common name:	Patient Examination Glove
Regulation Number:	21 CFR 880.6250
Regulatory Class:	Class I
Product code:	LZA, LZC,OPJ
Review Panel	General Hospital

III. Predicate Devices

510(k) Number:	K192315
Trade name:	Medline Green Ambidextrous Power-Free Nitrile ExaminationGloves With Colloidal Oatmeal USP (Tested For Use WithChemotherapy Drugs)
Common name:	Patient Examination Glove

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Classification: Class I

Product Code: LZA. LZC.OPJ Manufacturer Medline Industries, Inc.

IV. Device description

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).

V. Indication for use

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

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VI. Comparison of technological characteristics with the predicate devices Table 1 Comparison of Natural Rubber Surgical Gloves

Item	Proposed device(K211220)	Predicate device(K192315)	Discussion
Product name	Nitrile PatientExamination Gloves BlueTested For Use WithChemotherapy DrugsNitrile PatientExamination Gloves BlueViolet Tested For UseWith ChemotherapyDrugs	Medline GreenAmbidextrousPowder-Free NitrileExaminationGloves with ColloidalOatmeal USP (Testedfor use withChemotherapy Drugs)	-
Product Code	LZA, LZC,OPJ	LZA, LZC,OPJ	Same
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	Same
Classification	Class I	Class I	Same
Powder free	Yes	Yes	Same
Indication for use	A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves were testedfor use withChemotherapy drugs andFentanyl Citrate as perASTM D6978-05(Reapproved2019) Standard Practicefor Assessment ofMedical Gloves ofPermeation byChemotherapy Drugs	A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves weretested for use withChemotherapy drugsand Fentanyl Citrate asper ASTM D6978-05(Reapproved2013) Standard Practicefor Assessment ofMedical Gloves ofPermeation byChemotherapy Drugs	Similar*
Main Material	Powder-Free Nitrile	Powder-Free Nitrile	Same
Color	Blue, Blue violet	Blue	Similar*
Size	small, medium, large,x-large	x-small, small, medium,large, x-large	Similar*
Dimensions –Length	Complies with ASTMD6319-10S (220mm min)M (230mm min)L (230mm min)XL (230mm min)	Complies with ASTMD6319-10220mm min.	Similar*
Dimensions -Width	Complies with ASTMD6319-10Small (80±10mm)Medium (95±10mm)Large (110±10mm)X large (120±10mm)	Complies with ASTMD6319-10X-small - 70±10mmSmall - 80±10mmMedium - 95±10mmLarge - 110±10mmX-large - 120±10mm	Similar*
Dimensions –Thickness	Complies with:ASTM D6319-10Palm: 0.05mm minFinger: 0.11mm min	Complies with:ASTM D6319-10Palm - 0.05mm min.Finger – 0.05mm min.	Similar*
PhysicalProperties	Complies with:ASTM D6319-10minimum:Tensile Strength:Before Aging $≥$ 14 MPa,min.After Aging $≥$ 14 MPa,min.	Complies with:ASTM D6319-10minimum:Tensile Strength:Before Aging $≥$ 14MPa, min.After Aging $≥$ 14 MPa,min.	Same
	Elongation:Before Aging 500%, min.After Aging 400%, min.	Elongation:Before Aging 500%,min.After Aging 400%, min.	Same
Freedom fromHoles	Complies with ASTMD6319-10 and ASTMD5151-06 G-1, AQL 1.5	Complies with:ASTM D6319-10 andASTM D5151-06 G-1,AQL 1.5	Same
Powder orPowder-Free	Powder-Free	Powder-Free	Same
ResidualPowder	Complies with:ASTM D6319-10<2mg per glove	Complies with:ASTM D6319-10<2mg per glove	Same
ContactDurations	Limited <24 hours	Limited <24 hours	Same
Biocompatibility	AAMI/ANSI/ISO10993-10:Not a skin irritantNot a skin sensitizerAt the neat extraction, thetest article is consideredcytotoxic, but the acutesystemic toxicity resultsdemonstrate the devicewill not cause a systemiceffect.	AAMI/ANSI/ISO10993-10:Not a skin irritantNot a skin sensitizerAt the neat extraction, thetest article isconsidered cytotoxic, butthe acute systemictoxicity resultsdemonstrate the devicewill not cause a systemiceffect.	Same
Sterility	Non-sterile	Non-sterile	Same
Rx Only or OTC	Over the Counter	Over the Counter	Same
TestedChemotherapyDrugs	Carmustine (BCNU) 3.3mg/ml 65.3 minutesCisplatin 1.0 mg/ml >240minutesCyclophosphamide(Cytoxan) 20.0mg/ml >240 minutesDacarbazine (DTIC)10.0mg/ml >240 minutesDoxorubicinHydrochloride 2.0mg/ml >240 minutesEtoposide (Toposar) 20.0mg/ml >240 minutesFluorouracil 50.0mg/ml >240 minutesPaclitaxel (Taxol) 6.0mg/ml >240 minutesThiotepa 10.0 mg/ml58.3minutes	Carmustine (BCNU) 3.3mg/ml 65.3 minutesCisplatin 1.0mg/ml >240 minutesCyclophosphamide(Cytoxan) 20.0mg/ml >240 minutesDacarbazine (DTIC)10.0mg/ml >240 minutesDoxorubicinHydrochloride 2.0mg/ml >240 minutesEtoposide (Toposar)20.0 mg/ml >240minutesFluorouracil 50.0mg/ml >240 minutesPaclitaxel (Taxol) 6.0mg/ml >240 minutesThiotepa 10.0 mg/ml58.3minutesOther Drugs	SimilarThe TestedChemotherapy DrugsofPredicatedevice ismore thanProposeddevice

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*As above comparison, the difference in the dimensions and reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.

VII. Non-Clinical Testing

Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for ● Medical Application
ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves .
ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical . Gloves
ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air ● Oven
ASTM D412-16, Standard Test Methods for Vulcanized Rubber and ● Thermoplastic Elastomers-Tension
ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of . Medical Gloves to Permeation by Chemotherapy Drugs
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices Part11:Tests for . Systemic Toxicity

Test Method	Purpose	Acceptance Criteria	Results
ASTM D5151	Water Leak Test	The gloves shall be freefrom hole when tested inaccordance with themethod given in ASTMD5151.	pass
ASTM D3767	Dimension	The actual measureddimension of the glovesshall be meet the statedtolerance in Table 2 ofthe ASTM D 6319-19	pass
Before aging ASTMD412,After aging ASTMD573	Physical PropertiesTensile Strength,Ultimate Elongation	Before and afteraccelerated aging, thegloves shall conform tothe physicalrequirements in the	pass

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		Table 3 of ASTM 6319-19
ASTM D6124	Residual PowderContentPowder amount	The powder residuecontent shall be notmore than 2mg pergloves.	pass
ASTM D6978-05	ChemotherapyDrugs	Carmustine (BCNU) 3.3mg/ml 65.3 minutesCisplatin 1.0 mg/ml >240minutesCyclophosphamide(Cytoxan) 20.0 mg/ml>240 minutesDacarbazine (DTIC)10.0mg/ml >240 minutesDoxorubicinHydrochloride 2.0 mg/ml>240 minutesEtoposide (Toposar)20.0 mg/ml >240minutesFluorouracil 50.0 mg/ml>240 minutesPaclitaxel (Taxol) 6.0mg/ml >240 minutesThiotepa 10.0 mg/ml58.3minutes	pass
ISO 10993-10:2010	Skin irritation	non-sensitizing	pass
ISO 10993-10:2010	Skin Sensitization	non-irritating	pass
ISO 10993-11:2017	Acute SystemicToxicity	No acute system toxicity	pass

VIII. Clinical Testing

No clinical study is included in this submission.

IX. Conclusion

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