The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." It seeks to demonstrate substantial equivalence to a legally marketed predicate device.

The study described here is NOT for an AI/ML device, but rather for a physical medical device (examination gloves). Therefore, many of the requested items (e.g., number of experts, adjudication method, MRMC study, standalone algorithm performance, AI system effect size, sample size for training set, ground truth for training set) are not applicable to this type of device and are not present in the provided text.

However, I can extract information related to the acceptance criteria and how the physical glove device meets those criteria.

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and device performance are primarily based on established ASTM and ISO standards for examination gloves, particularly concerning physical properties, integrity, and resistance to permeation by chemotherapy drugs.

Test Method / Characteristic	Acceptance Criteria	Reported Device Performance
ASTM D6319 (Physical Dimensions)	Length:	Length:
	XS/S: ≥220 mm	XS/S: ≥220 mm (Pass)
	M/L/XL: ≥230 mm	M/L/XL: ≥230 mm (Pass)
	Width:	Width:
	XS: 70±10 mm	XS: 78-80 mm (Pass)
	S: 80±10 mm	S: 83-86 mm (Pass)
	M: 95±10 mm	M: 93-96 mm (Pass)
	L: 110±10 mm	L: 103-106 mm (Pass)
	XL: 120±10 mm	XL: 113-116 mm (Pass)
	Thickness:	Thickness:
	Finger: ≥0.05 mm	Finger: 0.07-0.10 mm (Pass)
	Palm: ≥0.05 mm	Palm: 0.06-0.07 mm (Pass)
ASTM D5151 (Watertightness for Detection of Holes)	Meet the requirements of ASTM D5151 AQL 2.5	0/125 / Pass (This likely means 0 failures out of 125 samples tested, meeting the AQL of 2.5)
ASTM D6124 (Powder Content)	Meet the requirements of ASTM D6124 < 2.0 mg per glove	0.16-0.30 mg per glove (Pass)
ASTM D412 (Physical Properties)	Before Aging:	Before Aging:
	Tensile Strength ≥14 MPa	14-29 MPa (Pass)
	Ultimate Elongation ≥500%	500-620 % (Pass)
	After Aging:	After Aging:
	Tensile Strength ≥14 MPa	14-23 MPa (Pass)
	Ultimate Elongation ≥400%	405-589 % (Pass)
ISO 10993-5 (Biocompatibility - Cytotoxicity)	Non-In Vitro Cytotoxicity	Under conditions of the study, device extract is cytotoxic. (This is a peculiar "Pass" result. It states cytotoxicity is present, but the overall conclusion for biocompatibility in the summary states it passed. This needs clarification from the original document source to understand if "cytotoxic" here means it passed the test for cytotoxicity, implying it was within acceptable limits, or if it indeed fails this specific measure but is overridden by other factors, which would be unusual.) Correction needed based on typical interpretation: this usually means it failed the cytotoxicity; however, in the context of the overall biocompatibility success, it implies the extract shows cytotoxicity but not to a degree that compromises safety, or that the acceptance criteria allows for some measurable cytotoxicity, or that subsequent in-vivo tests mitigated the concern.
ISO 10993-11 (Biocompatibility - Acute Systemic Toxicity)	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10 (Biocompatibility - Irritation)	Non-irritating	Under conditions of the study, not an irritant. / Pass
ISO 10993-10 (Biocompatibility - Sensitization)	Non-sensitizing	Under conditions of the study, not a sensitizer. / Pass
ASTM D6978 (Chemotherapy Drug & Fentanyl Permeation)	Breakthrough Detection Time (Minimums for various drugs as defined by standard practice or historical context)	Carmustine (3.3 mg/ml): 22.6 Minutes (Note: lower than predicate's white version) Cisplatin (1.0 mg/ml): >240 Minutes Cyclophosphamide (20.0 mg/ml): >240 Minutes Dacarbazine (10.0 mg/ml): >240 Minutes Doxorubicin HCI (2.0 mg/ml): >240 Minutes Etoposide (20.0 mg/ml): >240 Minutes Fluorouracil (50.0 mg/ml): >240 Minutes Methotrexate (25.0 mg/ml): >240 Minutes Mitomycin C (0.5 mg/ml): >240 Minutes Paclitaxel (6.0 mg/ml): >240 Minutes ThioTepa (10.0 mg/ml): 11.0 Minutes (Note: lower than predicate's) Vincristine Sulfate (1.0 mg/ml): >240 Minutes Fentanyl Citrate Injection (100.0 mcg/2ml): >240 Minutes

Study Information (as applicable to a physical medical device)

Sample Size Used for the Test Set and Data Provenance:
- Watertightness Test (Holes): 125 samples (0/125 / Pass).
- Physical Dimensions, Powder Content, Physical Properties (Tensile Strength, Elongation): Specific sample sizes for these tests are not explicitly stated, but are implied by the standard test methods (e.g., ASTM D6319, ASTM D6124, ASTM D412). Generally, these are conducted on a statistically significant number of samples per batch/lot to ensure quality.
- Biocompatibility Testing: The number of samples/animals used in ISO 10993 tests is not specified in this summary but would be detailed in the full test reports.
- Chemotherapy Permeation Testing: The number of samples tested per drug (as per ASTM D6978-05) is not specified in this summary.
- Data Provenance: The manufacturing entity is RMKH Glove (Cambodia) Co., Ltd. (Cambodia). The testing was conducted "in accordance with" various international standards (ASTM, ISO). The specific laboratories conducting the tests are not named, nor is it explicitly stated if the data is retrospective or prospective, though for
  510(k) submissions, bench testing is typically performed prospectively for the submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "ground truth" for this device is based on objective, quantifiable physical and chemical properties measured according to established international standards (ASTM, ISO), rather than expert interpretation of a diagnostic output.
Adjudication Method for the Test Set:
- Not applicable for objective physical and chemical bench testing. Test results are pass/fail based on pre-defined criteria from recognized standards.
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 medical device (examination glove), not an AI-powered diagnostic device.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (examination glove), not an AI-powered diagnostic device.
The Type of Ground Truth Used:
- Objective Measurement Data: The "ground truth" (or more appropriately, the performance benchmark) is established through adherence to recognized international standards and specifications for glove manufacturing and performance. This includes:
  - Physical dimensions
  - Mechanical properties (tensile strength, elongation)
  - Integrity (freedom from holes)
  - Chemical properties (powder content)
  - Biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity)
  - Permeation resistance to specific chemicals (chemotherapy drugs, fentanyl citrate).
- These are quantifiable measurements against pre-defined thresholds outlined in standards like ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993 series, and ASTM D6978.
The Sample Size for the Training Set:
- Not applicable. This is a physical medical device; there is no "training set" in the context of an AI/ML algorithm. The manufacturing process and formulation are developed to meet these standards.
How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set" or "ground truth for the training set" in the context of AI/ML algorithms for this device. The product development process aims to manufacture a device that consistently meets the performance specifications defined by the relevant ASTM and ISO standards.

Note on Biocompatibility (Cytotoxicity): The report states "Under conditions of the study, device extract is cytotoxic." However, the overall conclusion is that the device "passed" biocompatibility tests. This apparent contradiction is common in 510(k) summaries where initial in-vitro tests might show some cytotoxic effect, but subsequent analysis (e.g., considering dose, route of exposure, or the results of in-vivo tests like irritation or systemic toxicity) determines that the observed cytotoxicity is not clinically significant or that the device is still considered safe for its intended use. Without the full biocompatibility report, the exact rationale for this "pass" despite measurable cytotoxicity cannot be fully detailed.

Summary

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January 4, 2023

RMKH Glove (Cambodia) Co., Ltd. % Boyle Wang Official Correspondent ABMED Service Inc 1312 17th Street Suite 692 Denver, Colorado 80202

Re: K222907

Trade/Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: November 15, 2022 Received: November 15, 2022

Dear Boyle Wang:

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 mediation-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., 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) K22907

Device Name

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Indications for Use (Describe)

Tested chemotherapy drugs are as follows:

Chemotherapy Drug	Concentration	Breakthrough Detection Time in Minutes
Carmustine	3.3 mg/ml	22.6 Minutes
Cisplatin	1.0 mg/ml	240 Minutes
Cyclophosphamide	20.0 mg/ml	240 Minutes
Dacarbazine	10.0 mg/ml	240 Minutes
Doxorubicin HCI	2.0 mg/ml	240 Minutes
Etoposide	20.0 mg/ml	240 Minutes
Fluorouracil	50.0 mg/ml	240 Minutes
Methotrexate	25.0 mg/ml	240 Minutes
Mitomycin C	0.5 mg/ml	240 Minutes
Paclitaxel	6.0 mg/ml	240 Minutes
ThioTepa	10.0 mg/ml	11.0 Minutes
Vincristine Sulfate	1.0 mg/ml	240 Minutes

Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 22.6 Minutes; ThioTepa 10.0 mg/ml 11.0 Minutes.

Tested Fentanyl Citrate is as follows: Chemotherapy Drug Fentanyl Citrate Injection

Concentration 100.0 mcg/2ml

Breakthrough Detection Time in Minutes 240 Minutes

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.

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510(k) Summary K22907

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

RMKH GLOVE (CAMBODIA) CO., LTD. Name: Address: Manhattan Special Economic Zone, Bavet Commune, Bavet City, Svay Rieng Province, Cambodia Contact: Yang Clement KC Date of Preparation: Dec 28, 2022

Designated Submission Correspondent

Mr. Boyle Wang ABMED SERVICE INC Room 1312 17th Street Suite 692 Denver, CO US 80202 Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Nitrile Powder Free Examination Glove Tested for Use Trade name: with Chemotherapy Drugs and Fentanyl Citrate Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove XS, S, M, L, XL Model(s):

3.0 Classification

Production code: LZA, LZC, QDO, OPJ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Comfort Rubber Gloves Industries Sdn. Bhd Manufacturer: Device: Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) number: K192954

5.0 Device Description

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6.0 Indication for Use

Chemotherapy Drug	Concentration	Breakthrough DetectionTime in Minutes
Carmustine	3.3 mg/ml	22.6
Cisplatin	1.0 mg/ml	> 240
Cyclophosphamide	20.0 mg/ml	> 240
Dacarbazine	10.0 mg/ml	> 240
Doxorubicin HCI	2.0 mg/ml	> 240
Etoposide	20.0 mg/ml	> 240
Fluorouracil	50.0 mg/ml	> 240
Methotrexate	25.0 mg/ml	> 240
Mitomycin C	0.5 mg/ml	> 240
Paclitaxel	6.0 mg/ml	> 240
Thio Tepa	10.0 mg/ml	11.0
Vincristine Sulfate	1.0 mg/ml	> 240
Fentanyl Citrate Injection	100.0 mcg/2ml	> 240

Tested chemotherapy drugs are as follows:

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.6 Minutes; Thio Tepa 10.0 mg/ml 11.0 Minutes.

Warning: Please do not use with Carmustine and ThioTepa.

7.0 Technological Characteristic Comparison Table

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Item	Subject Device(K222907)	Predicate Device(K192954)	Remark
Product Code	LZA,LZC,QDO, OPJ	LZA,LZC,QDO	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	The Nitrile Powder FreeExamination Glove Testedfor Use withChemotherapy Drugs andFentanyl Citrate is aspecialty medical glovewhich is a disposabledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenexaminer and patient. Theglove was tested for usewith Chemotherapy Drugsand Fentanyl Citrate as perASTM D6978-05 StandardPractice for Assessment ofMedical Gloves toPermeation byChemotherapy Drugs.	The Blue Colored, PowderFree Nitrile ExaminationGloves, Non-sterile, andTested for Use withChemotherapy Drugs andFentanyl Citrate is aspecialty medical glovewhich is a disposabledevice intended formedical purpose that isworn on the examiner' shand or finger to preventcontamination betweenexaminer and patient. Theglove was tested for usewith Chemotherapy Drugsand Fentanyl Citrate as perASTM D6978-05 StandardPractice for Assessment ofMedical Gloves toPermeation byChemotherapy Drugs.	Same
Powdered or Powered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Sterility	Non-Sterile	Non-Sterile	Same
Labeling Information	Single-use indication,powder free, device color,device name, glove sizeand quantity,Non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults.	Single-use indication,powder free, device color,device name, glove sizeand quantity, Non-Sterile,a statement of standardASTM D6978-05compliance and asummary of the testingresults.	Same
Dimensions(mm)	Length:XS/S:≥220;M/L/XL: ≥230;	Length:XS/S/M/L/XL: ≥240;Width:	Similar

Table1-General Comparison

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	Width:
	XS: 70±10;	XS:70±10;
	S: 80±10;	S: 80±10;
	M: 95±10;	M: 95±10;
	L: 110±10;	L: 110±10;
	XL: 120±10.	XL: 120±10
		Finger: ≥0.05;	Finger: ≥0.05;	Same
	Thickness(mm)		Palm: ≥0.05		Palm: ≥0.05
	Colorant		Blue		Blue	Same
	PhysicalProperties	BeforeAging	TensileStrength	14MPa,min	TensileStrength	14MPa,min	Same
			UltimateElongation	500% min	UltimateElongation	500% min	Same
		After Aging	TensileStrength	14MPa,min	TensileStrength	14MPa,min	Same
			UltimateElongation	400%min	UltimateElongation	400%min	Same
	Freedom from Holes		Be free from holes whentested in accordancewith ASTMD5151AQL=2.5		Be free from holes whentested in accordancewith ASTMD5151AQL=2.5		Same
	Powder Content		0.16~0.30 mg per glove,Meet the requirementsof ASTM D6124		Meet the requirementsof ASTM D6124		Similar
	Biocompatibility		ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizerISO 10993-5Under conditions of thestudy, device extract iscytotoxicISO 10993-11;Under thecondition of acutesystemic toxicity test,the test article did notshow acute systemictoxicity in vivo.		ISO 10993-10;Under the conditions ofthe study, not an irritantor a sensitizerISO 10993-5Under conditions of thestudy, device extract iscytotoxicISO 10993-11;Under the conditions ofthe study, the subjectshowed no adversebiological reaction.		Same
ChemotherapyDrugs Testedwith MinimumBreakthroughDetection Time	Carmustine3.3 mg/ml	22.6 Minutes		White:18.2 Minutes		Similar
Cisplatin1.0 mg/ml	>240 Minutes		>240 Minutes		Different
Cyclophosph	>240 Minutes		>240 Minutes		Same

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-amide20.0 mg/ml
Dacarbazine10.0 mg/ml	>240 Minutes	>240 Minutes	Same
DoxorubicinHCI2.0 mg/ml	>240 Minutes	>240 Minutes	Same
Etoposide20.0 mg/ml	>240 Minutes	>240 Minutes	Same
Fluorouracil50.0 mg/ml	>240 Minutes	>240 Minutes	Same
Methotrexate25.0 mg/ml	>240 Minutes	/	Different
Mitomycin C0.5 mg/ml	>240 Minutes	/	Different
Paclitaxel6.0 mg/ml	>240 Minutes	>240 Minutes	Same
ThioTepa10.0 mg/ml	11.0 Minutes	57.3 Minutes	Different
VincristineSulfate1.0 mg/ml	>240 Minutes	/	Different
FentanylCitrateInjection100mcg/2ml	>240 Minutes	>240 Minutes	Same

Analysis 1:

The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Analysis 2:

Powder Content of subject device is similar with that of the predicate, because the predicate did not publish the exact results of the powder content. But they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Analysis 3:

And Breakthrough detection times of Carmustine and Thio Tepa of subject device are different with those of the predicate. The Chemotherapy Labeling Claims has clearly defined on the labeling. So it does not raise any new safety or performance questions.

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8.0 Summary of Non-Clinical Testing

Biocompatibility Testing

The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) was conducted in accordance with the following standards:

ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.

ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.

Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.

In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in -Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
-ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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TestMethod	Purpose	Acceptance Criteria	Results
ASTMD6319	PhysicalDimensionsTest	Length(mm):XS/S: ≥220;M/L/XL: ≥230.	Length(mm):XS/S: ≥220;M/L/XL: ≥230.
		Width(mm):XS: 70±10;S: 80±10;M: 95±10;L: 110±10;XL: 120±10.	Width(mm):XS: 78-80/PassS: 83-86/PassM: 93-96/ PassL: 103-106/ PassXL:113-116/ Pass
		Finger: ≥0.05;Palm: ≥0.05	Thickness (mm):Finger:0.07-0.10/Pass
			Palm:0.06-0.07/Pass

ASTMD5151	WatertightnessTest forDetection ofHoles	Meet the requirements of ASTM D5151AQL 2.5	0/125/Pass
ASTMD6124	PowderContent	Meet the requirements of ASTM D6124 <2.0mg	0.16-0.30mg/Pass
ASTMD412	Physicalproperties	BeforeAging	TensileStrength≥14MPa	14-29 MPa/Pass
			UltimateElongation≥500%	500-620 %/Pass
		AfterAging	TensileStrength≥14MPa	14-23 MPa/Pass
			UltimateElongation≥400%	405-589 %/Pass
ISO10993-5	Cytotoxicity	Non- In Vitro Cytotoxicity	Under conditions ofthe study, deviceextract is cytotoxic.
ISO10993-11	Cytotoxicity	Non- acute systemic toxicity	Under conditions ofthe study, did notshow acute systemictoxicity in vivo / Pass
ISO10993-10	Irritation	Non-irritating	Under conditions ofthe study, not anirritant. / Pass
ISO10993-10	Sensitization	Non-sensitizing	Under conditions ofthe study, not asensitizer. / Pass

Table 2 - Summary of non-clinical performance testing

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9.0 Summary of Clinical Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K192954.

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.