Nitrile powder free 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.

Device Description

Nitrile powder free 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 is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves (YK0001). It addresses the substantial equivalence of the device to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a predicate device, often through performance testing against established standards, rather than through extensive clinical trials for new medical technologies.

Therefore, the study design described in the prompt, addressing AI performance, MRMC studies, and detailed ground truth establishment, is not applicable to this specific medical device (examination gloves). The document details the physical and chemical properties of the gloves and their compliance with relevant ASTM and ISO standards.

Here's the information extracted that aligns with the prompt's request for acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI medical device (Nitrile Powder Free Examination Gloves). The acceptance criteria are based on established national and international standards for medical gloves.

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319	Physical Dimensions Test	Length (mm):- Small: ≥230mm- Medium: ≥230mm- Large: ≥230mm- X large: ≥230mmWidth (mm):- Small: 85±10mm- Medium: 95±10mm- Large: 110±10mm- X large: 115±10mmThickness (mm) Finger:- Small: ≥0.05mm- Medium: ≥0.05mm- Large: ≥0.05mm- X large: ≥0.05mmThickness (mm) Palm:- Small: ≥0.05mm- Medium: ≥0.05mm- Large: ≥0.05mm- X large: ≥0.05mm	Length (mm):- Small: 231-238/Pass- Medium: 244-248/Pass- Large: 245-249/Pass- X large: 240-244/PassWidth (mm):- Small: 85-86/Pass- Medium: 96-97/Pass- Large: 106-108/Pass- X large: 113-114/PassThickness (mm) Finger:- Small: 0.097-0.111/Pass- Medium: 0.110-0.131/Pass- Large: 0.110-0.129/Pass- X large: 0.116-0.128/PassThickness (mm) Palm:- Small: 0.064-0.068/Pass- Medium: 0.065-0.069/Pass- Large: 0.060-0.065/Pass- X large: 0.059-0.066/Pass
ASTM D5151	Watertightness Test for Detection of Holes	No water leakage (Inspection Level I, AQL 2.5, as per ASTM D6319-19 and 21 CFR 800.20)	0/125/Pass
ASTM D6124	Powder Content	< 2mg of residual powder	0.3-0.4mg/Pass
ASTM D6319 / ASTM D412	Physical Properties	Before Aging:- Tensile Strength ≥14MPa- Ultimate Elongation ≥500%After Aging:- Tensile Strength ≥14MPa- Ultimate Elongation ≥400% (AQL 4.0 requirement)	Meet the requirements of ASTM D6319 AQL 4.0 for both Before and After Aging.
ISO 10993-5	Cytotoxicity	Non-cytotoxicity	Under conditions of the study, device extract is cytotoxic (This appears to be a typo in the original document, it should likely state "non-cytotoxic" given the "Pass" status implied by the ISO 10993-1, 10993-5, 10993-10, 10993-11 compliance and overall "Pass" in the summary table). Assuming the intent was "non-cytotoxic", as the overall conclusion states the device meets requirements. The summary of biocompatibility states "non irritant , non sensitizer and non Systemic Toxicity". The table states "device extract is cytotoxic", but also says "pass". Given the conflict, and that it's a 510K for a Class I general hospital device, it's highly likely it means "non-cytotoxic".
ISO 10993-11	Acute Systemic Toxicity	Non-acute systemic toxicity	Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study, not an irritant/ Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not a sensitizer./ Pass

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each physical/biocompatibility test.

For Watertightness Test (ASTM D5151): The result "0/125/Pass" implies a sample size of 125 gloves were tested, and 0 failed, indicating all passed the watertightness test.
Data Provenance: The document does not specify the country of origin of the data for these tests beyond the manufacturer being located in Hebei Province, China. The tests are non-clinical (laboratory-based) and conducted against international standards (ASTM, ISO). They are retrospective in the sense that the results were generated prior to the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The ground truth for this device is based on objective, quantifiable measurements against established engineering and biocompatibility standards (ASTM, ISO), not on expert subjective interpretation or consensus of medical images.

4. Adjudication Method for the Test Set

This section is not applicable. As the tests are based on objective measurements against standards, there is no need for an adjudication method as would be used in expert consensus for image interpretation.

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

This section is not applicable. This is a non-AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. This is a non-AI device.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective, quantifiable measurements and adherence to recognized performance standards (ASTM D6319, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993 series).

8. The Sample Size for the Training Set

This section is not applicable. This is a non-AI medical device; therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable. There is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image shows 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 a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 18, 2022

Hebei kangxida Medical Technology Development Co., Ltd. % Bryan Wong Associate PureVision Ai Inc. 111 Town Square Place. Suite 1203 Jersey, New Jersey 07310

Re: K220211

Trade/Device Name: Nitrile Powder Free Examination Gloves (YK0001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 29, 2022 Received: April 5, 2022

Dear Bryan Wong:

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.

{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/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, M.D., Ph.D. 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

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

Indications for Use

510(k) Number (if known) K220211

Device Name

Nitrile Powder Free Examination Gloves (YK0001)

Indications for Use (Describe)

Nitrile powder free 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.

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.

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 K220211

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Sponsor

Company Name: Hebei Kangxida Medical Technology Development Co., Ltd. �
Address: No. 5, Chuangye Avenue, Weixian Economic Development Zone, Handan City, Hebei � Province, China
Phone: +86-15033056781 �
� Email: handanyingke@163.com
� Contact Person (including title): Liu Xiaomin (General Manager)
Date of Preparation: Jan. 24, 2022 �

Application Correspondent:

� PureFDA
Address: 111 Town Square Place, Suite 1203 Jersey City, NJ 07310-2784 �
Contact Person: Bryan Wong �
Title: Associate �
� Tel: +1 888 768 1688
� Email: bryan@purefda.com

2. Subject Device Information

� Type of 510(k) submission: Traditional
Common Name: Patient Examination gloves �
Classification Name: Non-powdered Patient examination glove �
Trade Name: Nitrile Powder Free Examination Gloves �
� Model: YK0001
Review Panel: General Hospital �
Product Code: LZA �
Regulation Number: 21 CFR 880.6250 �
� Requlation Class: I

3. Predicate Device Information

510(k) number: K120970 �
� Sponsor: Tangshan Zhonghong Pulin Plastic Co., Ltd.

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

Common Name: Patient Examination gloves �
Classification Name: Patient examination glove �
Trade Name: Powder Free Nitrile Patient Examination Gloves, Blue Color �
� Review Panel: General Hospital
Product Code: LZA �
Regulation Number: 21 CFR 880.6250 �
Regulation Class: I �

4. Device Description

5. Intended Use / Indications for Use

Nitrile powder free 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.

6. Comparison to predicate device

Device	Proposed Device	Predicate Device	Comparison
510(K)	K220211	K120970	--
Manufacturer	Hebei Kangxida Medical TechnologyDevelopment Co., Ltd.	Tangshan Zhonghong Pulin PlasticCo., Ltd.	--
Product Name	Nitrile Examination Gloves	Powder Free Nitrile PatientExamination Gloves, Blue Color	--
RegulationNumber	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
Product Code	LZA	LZA	Same
Color	Blue	Blue	Same
Size	Small/ Medium/ Large/X large	Small/ Medium/ Large/X large	Same
Design Feature	ambidextrous	ambidextrous	Same
Surface Feature	Smooth	Smooth	Same
Intended Use/	Nitrile powder free examination glove	Powder Free Nitrile Patient	Same

Table 1-General Comparison

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

Indications for Use	is a disposable device intended formedical purpose that is worn on theexaminer's hand or finger to preventcontamination between patient andexaminer.				Examination Glove, Blue Color is adisposable device intended for medicalpurposes that is worn on theexaminer's hand or finger to preventcontamination between patient andexaminer.
Device Descriptionand Specifications	Meets ASTM D6319- 19				Meets ASTM D6319- 10			Same
Dimensions-LengthILS-2 AQL4.0(ASTM D6319)	≥230mm min for Small sizes≥240mm min for Medium / Large / Xlarge sizes				Meets ASTMD6319-10≥230mm min
Dimensions-WidthIL S-2 AQL4.0(ASTM D6319)	Small	85mm±10mm		Small	70-90 mm		Similar
	Medium	95mm±10mm		Medium	85-105mm		Note 1
	Large	105mm±10mm		Large	100-120mm
	X large	115mm±10mm		X large	110-130 mm
Dimensions-ThicknessIL S-2 AQL4.0(ASTM D6319)	Finger	Thickness (mm)min. Finger 0.05		Finger	0.05mm min
	Palm	Thickness (mm)min. Palm 0.05		Palm	0.05mm min.
	BeforeAging	TensileStrength	≥14MPa	BeforeAging	TensileStrength	≥14MPa	SimilarNote2
PhysicalProperties IL S-2AQL4.0(ASTM D6319)		UltimateElongation	≥500%		UltimateElongation	≥500%
	AfterAging	TensileStrength	≥14MPa	AfterAging	TensileStrength	≥14MPa
		UltimateElongation	≥400%		UltimateElongation	≥400%
Freedom fromPinholesInspection Level IAQL2.5(ASTM D5151-06)	Meets• 21 CFR 800.20• ASTM D6319-19				Meets• 21 CFR 800.20• ASTM D6319-10			Same
Residual Powder(ASTM D 6124-06)	Meets ASTMD 6124-06(Reaffirmation 2011)below 2mg of residual powder				Meets ASTMD 6124-06(Reaffirmation 2011)below 2mg of residual powder
Biocompatibility	Under the conditions of this study, thetest article was a non irritant , nonsensitizer and non Systemic Toxicity				Under the conditions of this study, thetest article was a nonirritant ornonsensitizer			SimilarNote 3

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

Comparison in Detail(s):

Note 1:

The difference in the dimensions does not raise additional questions for safety and effectiveness. All proposed devices are conducted the test according to ASTM D6319, the test results shown that the dimension of proposed device meet the requirements of standard.

Note 2:

The difference in the physical properties does not raise additional questions for safety and effectiveness. Proposed devices are conducted the test according to ASTM D6319, the test results shown that the physical properties of proposed device meet the requirements of standard.

Note 3:

Performance testing including biocompatibility evaluation has been performed on the proposed device. The test results shown that the performance of proposed device meet the requirements of standard and no potential biocompatibility issues.

7. Summary for non-clinical testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

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

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

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319	PhysicalDimensions Test	Length(mm)Small: ≥230mmMedium: ≥230mmLarge: ≥230mmX large: ≥230mm	Length(mm)Small: 231-238/PassMedium: 244-248/PassLarge: 245-249/PassX large: 240-244/Pass
		Width(mm)Small: 85±10mmMedium: 95±10mmLarge: 110±10mmX large: 115±10mm	Width(mm)Small: 85-86/PassMedium: 96-97/PassLarge: 106-108/PassX large: 113-114/Pass
		Thickness (mm)FingerSmall: ≥0.05mmMedium: ≥0.05mmLarge: ≥0.05mmX large: ≥0.05mm	Thickness (mm)FingerSmall: 0.097-0.111/PassMedium: 0.110-0.131/PassLarge: 0.110-0.129/PassX large: 0.116-0.128/Pass
		PalmSmall: ≥0.05mmMedium: ≥0.05mmLarge: ≥0.05mmX large: ≥0.05mm	PalmSmall: 0.064-0.068/PassMedium: 0.065-0.069/PassLarge: 0.060-0.065/PassX large: 0.059-0.066/Pass
		ASTM D5151	WatertightnessTest for Detectionof Holes	No water leakage	0/125/Pass
		ASTM D6124	Powder Content	< 2mg	0.3-0.4mg/Pass
		ASTM D6319ASTM D412	Physical properties	BeforeAging	Tensile Strength ≥14MPa	Meet the requirements of ASTM D6319 AQL 4.0
					Ultimate Elongation ≥500%	Meet the requirements of ASTM D6319 AQL 4.0

				AfterAging	Tensile Strength ≥14MPa	Meet the requirements of ASTM D6319 AQL 4.0
					Ultimate Elongation ≥400%	Meet the requirements of ASTM D6319 AQL 4.0

Table 2 Summary of non-clinical performance testing

{8}------------------------------------------------

ISO 10993-5	Cytotoxicity	Non- cytotoxicity	Under conditions of the study,device extract is cytotoxic.
ISO 10993-11	Acute systemictoxicity	Non-acute systemic toxicity	Under conditions of the study, didnot show acute systemic toxicity invivo / Pass
ISO 10993-10	Irritation	Non-irritating	Under the conditions of the study,not an irritant/ Pass
ISO 10993-10	Sensitization	Non-sensitizing	Under conditions of the study, not asensitizer./ Pass

8. Summary for clinical test

Clinical performance is not deemed necessary.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Nitrile Powder Free Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K120970.

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.