Nitrile Powder Free 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

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

AI/ML Overview

The document describes the acceptance criteria and performance data for the "Nitrile Powder Free Patient Examination Gloves, Blue Color." The information is presented in the context of a 510(k) premarket notification, where the device's substantial equivalence to a predicate device is demonstrated through non-clinical performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Standard (Acceptance Criteria)	Device Performance	Result of Comparison
Dimension	ASTM standard D 6319-10.	Meets	Substantially equivalent
Physical Properties	ASTM standard D 6319-10.	Meets	Substantially equivalent
Freedom from Pinholes	21 CFR 800.20 ASTM D 5151-06 (Reapproved 2011)	Meets Holes at Inspection Level I AQL 2.5	Substantially equivalent
Powder Residual	ASTM standard D 6319-10 and D6124-06 (Reapproved 2011).	Meets < 2mg/glove (Results generated values below 2mg of residual powder.)	Substantially equivalent
Biocompatibility	Primary Skin Irritation in rabbits ISO 10993-10: Third Edition 2010-08-01. Dermal sensitization in the guinea pig ISO 10993-10: Third Edition 2010-08-01.	Passes (Not a Primary Skin Irritation) Passes (Not a Dermal sensitization)	Substantially equivalent
Dimensions -- Length	Meets ASTM D6319-10: ≥230mm min	230mm min for all sizes	Substantially equivalent
Dimensions -- Width	Meets ASTM D6319-10: Small 70-90 mm Medium 85-105mm Large 100-120mm Xlarge 110-130 mm	Small 83-87 mm Medium 93-97mm Large 104-109mm X large 114-119 mm	Substantially equivalent
Dimensions -- Thickness	Meets ASTM D6319-10: Finger 0.05mm min. Palm 0.05mm min.	Thickness (mm) min. Finger 0.10 mm min. Palm 0.06 mm min.	Substantially equivalent
Physical Properties	Meets ASTM D D6319-10: Before aging/after aging Elongation ≥500% Tensile Strength≥ 14MPa	Before aging/after aging Elongation :520-580% Tensile Strength:22-34 MPa	Substantially equivalent

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

Sample Size: The document does not explicitly state the specific numerical sample sizes for each test (e.g., number of gloves tested for dimensions, pinholes, etc.). It refers to meeting general ASTM standards and regulations (e.g., AQL 2.5 for pinholes), which inherently define sampling plans.
Data Provenance: The tests for physical properties, dimensions, pinholes, and powder residual appear to be based on product testing conducted by the manufacturer, Huikang Glove Co., Ltd., which is located in China. The biocompatibility tests (Primary Skin Irritation and Dermal Sensitization) were performed according to ISO 10993-10 standards. The studies are retrospective as they summarize data already collected.

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 to this type of device and study. The "ground truth" for patient examination gloves is established by objective, standardized physical and chemical testing methods dictated by ASTM and ISO standards, not expert consensus on medical image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

None. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For the physical and chemical testing of gloves, the results are quantitative and objective, determined by laboratory instruments and methods.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD systems that assist human interpretation in diagnostic tasks. The device in question is a medical glove, for which such a study is entirely inappropriate.

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

Not applicable. This device is a physical product (a medical glove), not a software algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.

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

The "ground truth" for this device is based on objective measurements against established industry standards and regulatory requirements. This includes:
- Physical measurements: Adherence to specified dimensions (length, width, thickness).
- Material properties: Tensile strength and elongation, as defined by ASTM D6319-10.
- Barrier integrity: Freedom from pinholes, assessed by waterleak tests (21 CFR 800.20, ASTM D5151-06).
- Chemical properties: Powder residual levels (ASTM D6124-06).
- Biocompatibility: Results from standardized irritation and sensitization tests (ISO 10993-10).

8. The sample size for the training set:

Not applicable. This device is a physical product, not an AI model requiring a training set. The manufacturing process is subject to quality control and adherence to standards, but there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for this device, a method for establishing its ground truth is irrelevant.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 3, 2014

Huikang Glove Company, Ltd. C/O Mr. Chu Xiaoan Beijing Easy-Link Company Room 1606, Bldg. 1 Jianxiang Yuan # 209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA

Re: K141287

Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examnation Glove Regulatory Class: I Product Code: LZA Dated: October 28, 2014 Received: October 30, 2014

Dear Mr. 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. 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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Page 2 - Mr. Xiaoan

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K141287

Device Name

Nitrile Powder Free 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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Section 6 510(k) Summary

510(K) Summary

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."

" "The assigned 510(k) number is:

Premarket Notification [510(k)] Summary

1.0 Submitter:

Submitter's name :	Huikang Glove Co., Ltd.
Submitter's address :	Wudaizhuang, Pachigang Town, LuannanCounty, Hebei Province, 063502, China
Phone number :Fax number :Name of contact person:	(86) 315-4169201(86) 315-4430333Zhang Liang
Date of preparation :	2014-10-28

2.0 Name of the Device

Device Name:	Nitrile Powder Free Patient ExaminationGloves, Blue Color
Proprietary/Trade name:	Nitrile Powder Free Patient ExaminationGloves, Blue Color
Common Name:	Exam gloves
Classification Name:	Patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital (80)
Product Code:	LZA

3.0 Predicate device

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

4.0 Device Description:

4.1 How the device functions:

Nitrile films form a barrier to body fluids and bloodborne Pathogens

4.2 Scientific concepts that form the basis for the device

The nitrile rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a

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medical procedure.

4.3 Physical and performance characteristics such as design, materials and physical properties:

Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

5.0 Device Intended Use (Indication for use):

6.0 Summary of the Technological Characteristics of the Device:

The Nitrile Powder Free Patient Examination Gloves, Blue Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 6319-10.	Meets
Physical Properties	ASTM standard D 6319-10.	Meets
Freedomfrompinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 6319-10 andD6124-06(Reapproved 2011).	Meets<2mg/glove
Biocompatibility	Primary Skin Irritation in rabbitsISO 10993-10: Third Edition2010-08-01.Dermal sensitization in theguinea pig ISO 10993-10: ThirdEdition 2010-08-01.	PassesNot a Primary SkinIrritationPassesNot a Dermalsensitization

7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

Nitrile Powder Free Patient Examination Gloves, Blue Color, meet requirements per ASTM D6319-10.per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: Third Edition 2010-08-01.

The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

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Features&Description	Predicate Device	Subject Device	ResultofComparison
Company	Tangshan Zhonghong PulinPlastic Co.,Ltd.	Huikang Glove Co., Ltd.	--
510(K) Number	K120970	K141287
Product name	Nitrile Powder Free PatientExamination Gloves, BlueColor	Nitrile Powder Free PatientExamination Gloves, Blue Color	same
Product Code	LZA	LZA	same
Size	Small/ Medium/Large/X large	Small/ Medium/Large/X large	same
Intend for use	Nitrile Powder Free PatientExamination Gloves, BlueColor is a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer.	Nitrile Powder Free PatientExamination Gloves, Blue Color isa disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contaminationbetween patient and examiner.	Substantiallyequivalent
DeviceDescription andSpecifications	Meets ASTM D6319-10	Meets ASTM D6319-10	Substantiallyequivalent
Dimensions--Length	Meets ASTMD6319-10≥230mm min	230mm min for all sizes	Substantiallyequivalent
Dimensions-- Width	Meets ASTM D6319-10Small 70-90 mmMedium 85-105mmLarge 100-120mmXlarge 110-130 mm	Small 83-87 mmMedium 93-97mmLarge 104-109mmX large 114-119 mm	Substantiallyequivalent
Dimensions--Thickness	Meets ASTM D6319-10Finger 0.05mm min.Palm 0.05mm min.	Thickness (mm) min.Finger 0.10 mm min.Palm 0.06 mm min.	Substantiallyequivalent
PhysicalProperties	Meets ASTM D D6319-10Before aging/after agingElongation ≥500%Tensile Strength≥ 14MPa	Before aging/after agingElongation :520-580%Tensile Strength:22-34 MPa	Substantiallyequivalent
FreedomfromPinholes	Meets• 21 CFR 800.20• ASTM D6319-10• ASTM D 5151-06(Reapproved 2011)	Meets ASTMD5151-06(Reapproved 2011)Holes atInspection Level IAQL2.5	Substantiallyequivalent
ResidualPowder	Meets ASTMD 6124-06(Reapproved 2011)below 2mg of residualpowder	Meets ASTMD 6124-06(Reapproved 2011)Results generated values below2mg of residual powder	Substantiallyequivalent
Materials usedto fabricate thedevices	Nitrile	Nitrile	Substantiallyequivalent
Dusting orDonningPowder:	PU	PU	Substantiallyequivalent
Dusting orDonningPowder: name	PU	Surface Coating Agent	Substantiallyequivalent
Compareperformancedata supportingsubstantialequivalence	MeetsASTM D5151-06(Reapproved 2011)ASTM D6319-10ASTM D6124-06(Reapproved 2011)	MeetsASTM D5151-06(Reapproved 2011)ASTM D6319-10ASTM D6124-06(Reapproved 2011)	Substantiallyequivalent
Single PatientUse	Single Patient Use	Single Patient Use	Substantiallyequivalent
Biocompatibility	SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006	Under the conditions of the study,not an irritant and underconditions of the study, not asensitizer.SKIN IRRITATION DERMALand SENSITIZATION STUDIESMeets ISO 10993-10: ThirdEdition 2010-08-01.	Substantiallyequivalent
Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed.	-Powder Free-Patient Examination Glove-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	Substantiallyequivalent

9.0 Substantial Equivalence Comparison:

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10.0 Substantial Equivalence Comparison:

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue Color is as safe, as effective, and performs as well as the predicate device, Nitrile Powder Free Patient Examination Gloves, Blue Color, Tangshan Zhonghong Pulin Plastic Co.,Ltd.. 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.