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 text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," which is a Class I medical device. This type of device does not typically involve complex algorithms or AI; instead, its performance is evaluated based on physical characteristics and material biocompatibility against established standards. Therefore, the requested information regarding AI-specific evaluation criteria (like multi-reader multi-case studies, expert adjudication, AI effect size, training set details) is not applicable to this submission.

Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:

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

Feature/Test	Acceptance Criteria (Predicate or Standard)	Reported Device Performance (Subject Device)	Result
Dimensions - Length (ASTM D6319-10)	≥230mm min	232 mm min for all sizes	Similar
Dimensions - Width (ASTM D6319-10)	Small: 70-90mmMedium: 85-105mmLarge: 100-120mmX large: 110-130mm	Small: 76-90 mmMedium: 87-102 mmLarge: 108-119mmX large: 115-128 mm	Similar
Dimensions - Thickness (ASTM D6319-10)	Finger: 0.05mm min.Palm: 0.05mm min.	Fingertip: ≥0.08mmPalm: ≥0.08mm	Similar
Physical Properties - Tensile Strength (Before & After aging) (ASTM D6319-10)	≥ 14MPa	Before Aging: 18-25 MPaAfter Aging: 17-22 MPa	Similar
Physical Properties - Elongation (Before aging) (ASTM D6319-10)	≥500%	Before Aging: 550-610%	Similar
Physical Properties - Elongation (After aging) (ASTM D6319-10)	≥400%	After Aging: 450-570%	Similar
Freedom from Pinholes (21 CFR 800.20, ASTM D6319-10)	Inspection Level I AQL2.5; Accept/Reject criteria of 10/11 (Predicate)	Water leakage test: 5 noncompliance is allowed.	Similar
Residual Powder (ASTM D6124-06)	Below 2mg of residual powder	Mean: 0.1mg/pcs	Pass
Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010)	Non-irritant	Under the conditions of the study, the subject device is not a primary skin irritant.	Passes
Biocompatibility - Dermal Sensitization (ISO 10993-10:2010)	Non-sensitizer	Under the conditions of the study, the subject device is not a skin sensitizer.	Passes
Biocompatibility - Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxicity to L-929 cells	Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells.	Pass
Biocompatibility - Acute Systemic Toxicity (ISO 10993-11:2017)	No systemic toxicity concern	Under the conditions of study the device extracts do not pose a systemic toxicity concern.	Pass

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

The document does not specify the exact sample sizes for each physical test. However, it indicates general inspection levels where applicable, such as "ILS-2 AQL4.0" for dimensions and "Inspection Level I AQL2.5" for freedom from pinholes. For residual powder, it states "Checked on 5pcs sub-samples (N=5)."
The provenance of the data is from non-clinical laboratory testing performed by the manufacturer to demonstrate compliance with relevant ASTM and ISO standards. The document does not specify the country of origin of the raw data, but the manufacturer is Shandong Shangwei Medical Products Co.,Ltd, located in China. The studies are prospective in nature, as they are specifically conducted to test the performance of the device against predefined criteria.

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

Not applicable. The "ground truth" for this device is based on objective measurements against established international and national standards (ASTM, ISO, CFR) for physical properties and biocompatibility. It does not involve expert interpretation or subjective assessment of medical images or patient conditions.

4. Adjudication method for the test set

Not applicable. As described above, this is not an AI or diagnostic device requiring expert adjudication. Test results are quantitative measurements compared against predefined thresholds in standards.

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 patient examination glove and does not involve AI or human "readers" in a diagnostic capacity.

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

Not applicable. There is no algorithm for this device.

7. The type of ground truth used

The ground truth used for this device's evaluation is based on established industry standards and objective laboratory measurements. These include:

ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
21 CFR 800.20 and ASTM D5151-19 for freedom from pinholes.
ASTM D6124-06 for residual powder.
ISO 10993-5, ISO 10993-10, and ISO 10993-11 for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 10, 2021

Shandong Shangwei 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: K210779

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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

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)

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510(K) Summary

K210779

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 Shangwei 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: Ms. Li Hua Phone number: 0086-530-2069711 Date of preparation: 2021-11-08

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(K210779)	Result ofComparison
Product name	Powder Free Nitrile PatientExamination Glove, Blue Color	Powder Free Nitrile PatientExamination 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 PatientExamination Glove, Blue Coloris a disposable device intendedfor medical purposes that isworn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner.	Powder Free Nitrile PatientExamination Gloves, Blue Color isa disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner.	Same

6.0 Technological Characteristic Comparison:

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Device Descriptionand Specifications	Meets ASTM D6319-10		Meets ASTM D6319-10(Reapproved 2015)		Same	Test Methodology	Purpose	Acceptance Criteria	Results
Dimensions --LengthILS-2 AQL4.0(ASTMD 6319-10)	≥230mm min		232 mm min for all sizes		Similar	ASTM D 6319-06(Reapproved2015).	Dimension	Length	≥230mm
Dimensions-- WidthIL S-2 AQL4.0(ASTM D6319-10)	Small	70-90 mm	Small	76-90 mm	Similar			Width	Small	76-90 mm
	Medium	85-105mm	Medium	87-102 mm					Medium	87-102 mm
	Large	100-120mm	Large	108-119mm					Large	108-119mm
	X large	110-130 mm	X large	115-128 mm					X large	115-128 mm
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			Thickness	Fingertip	≥0.08mm
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 (%):550-610After Aging Elongation (%):450-570Before Aging Tensile Strength(MPa): 18-25After Aging Tensile Strength(MPa): 17-22	Similar				Palm	≥0.08mm
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	ASTM D 6319-06(Reapproved2015).	PhysicalProperties	Tensile strength(Before & Afteraging)	≥14MPa	17-25
InspectionLevelAQL2.5	I							Before aging Elongation	≥500%	550-610
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			After aging Elongation	≥400%	450-570
Materials used tofabricate the devices	Nitrile			Nitrile	Same	• 21 CFR 800.20• ASTM D 6319-06(Reapproved2015).• ASTM D5151-19	Freedomfrom pinholes	Water leakage test:Inspection Level I, AQL2.5, andAccept/Reject criteria of 10/11.		5noncomplianceis allowed.
Single Patient Use	Single Patient Use			Single Patient Use	Same	• ASTM D6319-10(Reapproved2015)	PowderResidual	Meets<2mg/glove		Mean:0.1mg/pcs
Biocompatibility	Under the conditions of this study,the test article was a non- irritant ornon- sensitizer (ISO 10993-10:2002/Amd.1:2006)N/AN/A			Under the conditions of this study,the test article was a non- irritant ornon- sensitizer (ISO 10993-10:Third Edition 2010-08-01)Cytotoxicity study meets ISO 10993-5 Third edition 2009-06-01Under the conditions of study, thedevice extracts do not pose asystemic toxicity concern (ISO10993-11:2017)	SimilarDifferentDifferent	• ASTM D6124-06(Reapproved2017),				Pass
Labeling	-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile			-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color- Non sterile	Same	Primary SkinIrritation in rabbitsISO 10993-10: 2010-08-01	Biocompatibility	Under the conditions of the study,the subject device is not aprimary skin irritant.		Passes
Dermal sensitizationin the guinea pig ISO10993-10: 2010-08-01		Under the conditions of the study,the subject device is not a skinsensitizer.		Passes

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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.

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The test article wasadded to L929 cellsmeasured by MTTassay ISO 10993-5:2009	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

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.