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. It's 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 provided document is a 510(k) summary for the Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested fields are not applicable to the context of this document.

Here's the information that can be extracted from the provided text, formatted to address your request:

Acceptance Criteria and Device Performance

Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
Dimensions	ASTM standard D 6319-10.	Meets
Dimensions - Length	ASTM D6319-10 ≥230mm min	Meets ASTM D6319-10 ≥230mm min for all sizes
Dimensions - Width	ASTM D6319-10 Small: 70-90 mm; Medium: 85-105mm; Large: 100-120mm; Xlarge: 110-130 mm	Meets ASTM D6319-10 Small: 70-90mm; Medium: 85-105mm; Large: 100-120mm; Xlarge: 110-130mm
Dimensions - Thickness	ASTM D6319-10 Finger: 0.05mm min.; Palm: 0.05mm min.	Meets ASTM D6319-10 Finger: 0.05mmmin.; Palm: 0.05mmmin.
Physical Properties	ASTM standard D 6319-10.	Meets
Physical Properties (Elongation & Tensile Strength)	ASTM D D6319-10 Before aging/after aging Elongation ≥500%; Tensile Strength ≥ 14MPa	Meets ASTM D D6319-10 Before aging/after aging Elongation ≥500%; Tensile Strength ≥ 14MPa
Freedom from pinholes	21 CFR 800.20; ASTM D6319-10; ASTM D 5151-06 (Reapproved 2011)	Meets; Holes at Inspection Level I AQL 2.5
Powder Residual	ASTM standard D 6319-10 and D6124-06 (Reapproved 2011)	Meets; <2mg/glove
Biocompatibility	Primary Skin Irritation in rabbits ISO 10993-10: Third Edition 2010-08-01.	Under the conditions of the study, the subject device is non-irritating
Biocompatibility (Sensitization)	Dermal sensitization in the guinea pig ISO 10993-10: Third Edition 2010-08-01.	Under the conditions of the study, the subject device is not a sensitizer

Study Details (Based on the Provided Document which is a 510(k) Summary)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify general "test set" sample sizes or data provenance in the context of clinical studies for performance evaluation of a device like an AI. Instead, it refers to compliance with ASTM standards and biocompatibility studies. The specific sample sizes for tests like pinhole detection, tensile strength, or biocompatibility are not detailed, but implied to be sufficient for standard compliance.
- Data Provenance: Not explicitly stated for each test, but the submitter is Zhonghong Pulin Medical Products Co., Ltd. from Hebei, China. Biocompatibility studies specify rabbits and guinea pigs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is a medical glove, not an AI diagnostic device requiring expert interpretation for ground truth. Ground truth for its performance properties is established through standardized physical, chemical, and biological testing as per ASTM and ISO standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies where human interpretation of medical data and subsequent consensus is needed to establish ground truth (e.g., in diagnostic AI), which is not the case for a patient examination glove.
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 medical glove, not an AI system or software requiring comparison of human reader performance with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (glove), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is established by conformance to established industry standards (ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, 21 CFR 800.20) and biocompatibility testing results (ISO 10993-10). For example, "Freedom from pinholes" has a ground truth defined by the water leak test method described in 21 CFR 800.20. Biocompatibility has ground truth based on observed biological reactions in animal models.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI models with training sets.
How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or AI models with training sets.

Summary

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

March 9, 2016

Zhonghong Pulin Medical Products Co., Ltd. c/o Mr. Chu Xiaoan Room 1606 Bldg. 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA

Re: K152712

Trade/Device Name: Nitrile Powder Free Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: January 28, 2016 Received: February 1, 2016

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152712

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: K152712

Premarket Notification [510(k)] Summary

1.0 Submitter:

Submitter's name :	Zhonghong Pulin Medical Products Co.,Ltd.
Submitter's address :	Pachigang Industrial Park,Luannan County,Tangshan City, 063502 Hebei, China
Phone number :	(86)315-4165760
Fax number :	(86)315-4167664
Name of contact person:	LI Jinge
Date of preparation :	2016-03-02

2.0 Name of the Device

Device Name:	Nitrile Powder Free Patient ExaminationGloves, Blue Color
Proprietary/Trade name:	Zhonghong Pulin Nitrile Powder Free PatientExamination Gloves, 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 Gloves,
	Blue 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. It's 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 and	Meets
	D6124-06(Reapproved 2011).	<2mg/glove
Biocompatibility	Primary Skin Irritation in rabbits	Under the conditions of
	ISO 10993-10: Third Edition	the study, the subject
	2010-08-01.	device is non-irritating
	Dermal sensitization in the	Under the conditions of
	guinea pig ISO 10993-10: Third	the study, the subject
	Edition 2010-08-01.	device is not a sensitizer

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 was not needed for this submission.

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Features&Description	Predicate Device	Subject Device	ResultofComparison
Company	Tangshan Zhonghong PulinPlastic Co.,Ltd.	Zhonghong Pulin MedicalProducts Co.,Ltd.	--
510(K) Number	K120970	K152712
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 contamination betweenpatient and examiner.	Substantiallyequivalent
DeviceDescription andSpecifications	Meets ASTM D6319-10	Meets ASTM D6319-10	Substantiallyequivalent
Dimensions--Length	Meets ASTMD6319-10≥230mm min	Meets ASTMD6319-10≥230mm min for all sizes	Substantiallyequivalent
Dimensions-- Width	Meets ASTM D6319-10Small 70-90 mmMedium 85-105mmLarge 100-120mmXlarge 110-130 mm	MeetsASTMD6319-10Small 70-90mmMedium 85-105mmLarge 100-120mmXlarge 110-130mm	Substantiallyequivalent
Dimensions--Thickness	Meets ASTM D6319-10Finger 0.05mm min.Palm 0.05mm min.	MeetsASTMD6319-10Finger 0.05mmmin.Palm 0.05mmmin.	Substantiallyequivalent
PhysicalProperties	Meets ASTM D D6319-10Before aging/after agingElongation ≥500%Tensile Strength≥ 14MPa	MeetsASTMD D6319-10Beforeaging/afteragingElongation≥500%Tensile Strength≥14MPa	Substantiallyequivalent
FreedomfromPinholes	Meets• 21 CFR 800.20• ASTM D6319-10• ASTM D 5151-06(Reapproved 2011)	Meets• 21 CFR 800.20• ASTM D6319-10• ASTM D5151-06(Reapproved 2011)Holes atInspection Level IAQL2.5	Substantiallyequivalent
ResidualPowder	Meets ASTMD 6124-06(Reapproved 2011)	Meets ASTMD 6124-06(Reapproved 2011)	Substantiallyequivalent
	powder	2mg of residual powder
Materials usedto fabricate thedevices	Nitrile	Nitrile	Substantiallyequivalent
Dusting orDonningPowder: name	PU	Polyurethane	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
SingleUse	Single Patient Use	Single Patient Use	Substantiallyequivalent
Biocompatibility	SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006Under the conditions of thestudy, not an irritant andunder conditions of thestudy, not a sensitizer.	SKIN IRRITATION DERMALand SENSITIZATION STUDIESMeets ISO 10993-10: ThirdEdition 2010-08-01.Under the conditions of the study,not an irritant and underconditions of the study, not asensitizer.	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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Substantial Equivalence Comparison: 10.0

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.