Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. It details the device's characteristics and compares them to a predicate device to establish substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The device's performance is compared against established standards, primarily ASTM D6319-10 (Reapproved 2015) for Nitrile Examination Gloves for Medical Application, along with other ISO and ASTM standards for biocompatibility and specific tests.

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D 6319-06 (Reapproved 2015)	Dimension
- Length		≥230mm min	232 mm min for all sizes (Similar to predicate)
- Width		Small: 70-90 mmMedium: 85-105mmLarge: 100-120mmX large: 110-130 mm	Small: 75-90 mmMedium: 88-102 mmLarge: 107-117mmX large: 114-128 mm (Similar to predicate)
- Thickness		Fingertip: ≥0.05mm min.Palm: ≥0.05mm min.	Fingertip: ≥0.08mmPalm: ≥0.08mm (Similar to predicate)
ASTM D 6319-06 (Reapproved 2015)	Physical Properties
- Tensile strength (Before & After aging)		≥ 14MPa	17-24 (Before Aging), 17-22 (After Aging) (Similar to predicate)
- Before aging Elongation		≥500%	540-610 (Similar to predicate)
- After aging Elongation		≥400%	460-570 (Similar to predicate)
21 CFR 800.20ASTM D 6319-06 (Reapproved 2015)ASTM D5151-19	Freedom from pinholes	Water leakage test: Inspection Level I, AQL 2.5, and Accept/Reject criteria of 10/11.	5 noncompliance is allowed (Similar to predicate)
ASTM D6319-10 (Reapproved 2015)ASTM D6124-06 (Reapproved 2017)	Powder Residual	<2mg/glove	Mean: 0.1mg/pcs (Similar to predicate)
Biocompatibility (ISO 10993-10:2010-08-01 - Primary Skin Irritation/Dermal Sensitization)	Biocompatibility	Non-irritant or non-sensitizer	Pass (Non-irritant, non-sensitizer) (Similar to predicate)
Biocompatibility (ISO 10993-5:2009 - Cytotoxicity)	Biocompatibility	Non-cytotoxicity to L-929 cells.	Cytotoxic (requires additional testing to assess systemic toxicity concern) (Different from predicate, further tested)
Biocompatibility (ISO 10993-11:2017 - Acute Systemic Toxicity)	Biocompatibility	Device extracts do not pose a systemic toxicity concern.	Pass (Device extracts do not pose a systemic toxicity concern) (Different from predicate)

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

The document does not explicitly state a specific numerical sample size for each test. However, it references industry standards like Inspection Level I, AQL 2.5, for Freedom from Pinholes which implies a statistically determined sample size for quality control testing of physical properties. For residual powder, it states "Checked on 5pcs sub-samples (N=5)".

Data Provenance: The document does not explicitly state the country of origin of the data collection or if the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests performed (material properties, biocompatibility), these are typically controlled laboratory tests conducted during the device's development phase, likely in China where the manufacturer is located.

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

This 510(k) submission is for patient examination gloves, which are assessed based on established physical, chemical, and biological performance standards (e.g., ASTM, ISO). The "ground truth" is defined by meeting these predefined quantitative criteria. Therefore, there isn't a concept of "experts establishing ground truth" in the same way as with diagnostic AI. The performance is objectively measured against the specified thresholds in the standards by qualified testing laboratories.

4. Adjudication Method for the Test Set:

Not applicable in this context. The testing involves objective measurements against pre-defined numerical and qualitative standards, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device (patient examination gloves) that does not involve diagnostic interpretation or human-in-the-loop performance improvement in the typical sense of an AI/imaging device. Clinical testing was explicitly stated as "not needed for this device."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical product, not a software algorithm. The "performance" is its intrinsic physical and biological characteristics.

7. The Type of Ground Truth Used:

The ground truth is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993, 21 CFR 800.20) for physical properties, chemical composition, and biocompatibility of patient examination gloves. These are objective, measurable performance criteria.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a "training set." The device's characteristics are determined by its manufacturing process and tested against objective standards, not by an algorithm learning from data.

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

Not applicable for the reason stated in point 8.

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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 2, 2021

Shandong Jieshi Medical Products Co.,Ltd Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Chaoyung District Beijing, 100121 China

Re: K210777

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 17, 2021 Received: October 19, 2021

Dear Chu Xiaoan:

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.

For 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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K210777

Device Name

Powder Free Nitrile Patient Examination Gloves, Blue Color

Indications for Use (Describe)

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

K210777

This summary of 510(k) is being submitted in accordance with 21 CFR 807.

Premarket Notification [510(k)] Summary

1.0 Submitter:

Submitter's name: Shandong Jieshi Medical Products Co., Ltd Submitter's address: North Road, Fumin Avenue, Qinghe Street, Caoxian County, Heze City, Shandong Province, 274400,P.R. China Name of contact person: Mr. Li Biao Phone number: 0086-530-2061157 Date of preparation: 2021-11-01

2.0 Name of the Device

Proprietary/Trade name: Powder Free Nitrile Patient Examination Gloves, Blue Color Common Name: Patient Examination gloves Classification Name: Non-powdered Patient examination glove Device Classification: I Regulation: 21 CFR 880.6250 Panel: General Hospital Product Code: LZA

3.0 Predicate device

Device Name: Powder Free Nitrile Patient Examination Glove, Blue Color Company name: Tangshan Zhonghong Pulin Plastic Co., Ltd. 510(K) Number: K120970

4.0 Device Description:

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

5.0 Indications for Use Statement:

Features & Description	Predicate Device (K120970)	Subject Device (K210777)	Result of Comparison
Product name	Powder Free Nitrile Patient Examination Glove, Blue Color	Powder Free Nitrile Patient Examination Gloves, Blue Color	Same
Regulation Number	21CFR880.6250	21CFR880.6250	Same
Product Code	LZA	LZA	Same
Color	Blue	Blue	Same
Size	Small/ Medium/ Large/X large	Small/ Medium/ Large/X large	Same
Indications for Use	Powder Free Nitrile Patient Examination Glove, Blue Color 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.	Powder Free Nitrile Patient Examination Gloves, Blue Color 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.	Same

6.0 Technological Characteristic Comparison:

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

Device Descriptionand Specifications		Meets ASTM D6319-10	Meets ASTM D6319-10(Reapproved 2015)		Same
Dimensions --LengthILS-2 AQL4.0(ASTMD 6319-10)	≥230mm min		232 mm min for all sizes		Similar
Dimensions-- WidthIL S-2 AQL4.0(ASTM D6319-10)	SmallMediumLargeX large	70-90 mm85-105mm100-120mm110-130 mm	SmallMediumLargeX large	75-90 mm88-102 mm107-117mm114-128 mm	Similar
Dimensions--ThicknessIL S-2 AQL4.0(ASTM D6319-10)	Finger 0.05mm min.Palm 0.05mm min.		Thickness (mm) min.Finger 0.08Palm 0.08		Similar
Physical PropertiesIL S-2 AQL4.0(ASTM D D6319-10)	Before aging/after aging TensileStrength≥ 14MPaBefore aging Elongation ≥500%After aging Elongation ≥400%		Before Aging Elongation (%):540-610After Aging Elongation (%):460-570Before Aging Tensile Strength(MPa): 19-24After Aging Tensile Strength(MPa): 17-22		Similar
Freedom fromPinholes	Meets• 21 CFR 800.20• ASTM D6319-10		1) Inspection Level I AQL2.5, andAccept/Reject criteria of 10/112) Water leakage test: 5noncompliance is allowed.		Similar
InspectionLevelAQL2.5	I
Residual Powder(ASTM D 6124-06(Reaffirmation2011))	below 2mg of residualpowder		1) Checked on 5pcssub-samples (N=5).2) Result as following:Mean: 0.1mg/pcs		Similar
Materials used tofabricate the devices	Nitrile		Nitrile		Same
Single Patient Use	Single Patient Use		Single Patient Use		Same
Biocompatibility	Under the conditions of this study,the test article was a non- irritant ornon- sensitizer (ISO 10993-10:2002/Amd.1:2006)		Under the conditions of this study,the test article was a non- irritant ornon- sensitizer (ISO 10993-10:Third Edition 2010-08-01)		Similar
	N/A		Cytotoxicity study meets ISO 10993-5 Third edition 2009-06-01		Different
	N/A		Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern (ISO10993-11:2017)		Different
Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed.	-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot-Blue color		-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile		Same

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

7.0 Discussion of Non-clinical and Performance 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 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

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 - 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 D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.

Test Methodology	Purpose	Acceptance Criteria	Results
ASTM D 6319-06(Reapproved2015).	Dimension	Length	≥230mm
		Width	Small	75-90 mm
			Medium	88-102 mm
			Large	107-117mm
			X large	114-128 mm
		Thickness	Fingertip	≥0.08mm
			Palm	≥0.08mm
ASTM D 6319-06(Reapproved2015).	PhysicalProperties	Tensile strength(Before & Afteraging)	≥14MPa	17-24
		Before agingElongation	≥500%	540-610
		After agingElongation	≥400%	460-570
• 21 CFR 800.20• ASTM D 6319-06(Reapproved2015).• ASTM D5151-19	Freedom frompinholes	Water leakage test:Inspection LevelI, AQL2.5, andAccept/Reject criteria of 10/11.		5noncomplianceis allowed.
• ASTM D6319-10(Reapproved2015)	PowderResidual	Meets<2mg/glove		Mean:0.1mg/pcs
• ASTM D6124-06 (Reapproved2017),	Biocompatibility	Under the conditions of the study,the subject device is not aprimary skin irritant.		Pass
Primary SkinIrritation in rabbitsISO 10993-10:2010-08-01				Passes
Dermalsensitization in theguinea pig ISO10993-10: 2010-08-01		Under the conditions of the study,the subject device is not a skinsensitizer.		Passes

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

The test article wasadded to L929cells measured byMTT assay ISO10993-5: 2009	Under the conditions of thisstudy, the test article was non-cytotoxicity to L-929 cells.	Under theconditions of thestudy, cytotoxic.Additionaltesting wasperformed todetermine if thiswas a systemictoxicity concern.
Acute SystemicToxicity Systemicinjection in miceISO 10993-11:2017	Under the conditions of studythe device extracts do not pose asystemic toxicity concern	Pass

8.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

9.0 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 predicated 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.