The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.

Device Description

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTMD5151, and ASTMD5250. The proposed device is non-sterile.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a Vinyl Patient Examination Glove, asserting substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device meets established standards for medical examination gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized industry standards, and the reported device performance is presented as compliance with these standards or specific measured values.

Item	Acceptance Criteria	Reported Device Performance
General
Product Code	LYZ	LYZ
Regulation No.	21CFR880.6250	21CFR880.6250
Class	I	I
Indications for Use	Disposable device for medical purposes, worn on examiner's hands to prevent contamination.	Same as predicate device.
Powdered/Powder-free	Powdered free	Powdered free
Design Feature	Ambidextrous	Ambidextrous
Surface Feature	Smooth	Smooth
Labeling Info	Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile.	Same as predicate device.
Material	Vinyl	Vinyl
Label & Labeling	Meet FDA's Requirement	Meet FDA's Requirement
Dimensions
Length (XS, S, M, L, XL)	230mm (XS, S), 235mm (M), 245mm (L, XL) min	230mm (XS, S), 235mm (M), 245mm (L, XL) min
Width (XS, S, M, L, XL)	80mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) +/-5mm	80mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) +/-5mm
Thickness (Finger)	0.05 mm min	0.05 mm min
Thickness (Palm)	0.08 mm min	0.08 mm min
Performance
Colorant	N/A (Predicate had White, Blue, Yellow)	Clear, Non-Colored (Difference addressed by biocompatibility testing results)
Tensile Strength (Before Aging)	15MPa, min (ASTM D5250)	15MPa, min
Ultimate Elongation (Before Aging)	380% min (ASTM D5250)	380% min
Tensile Strength (After Aging)	15MPa, min (ASTM D5250)	15MPa, min
Ultimate Elongation (After Aging)	380% min (ASTM D5250)	380% min
Freedom from Holes	AQL=1.5 when tested with ASTMD5151	Be free from holes when tested in accordance with ASTMD5151 AQL=1.5
Powder Content	Meet the requirements of ASTM D6124	0.48 (This value implies it meets the requirements of ASTM D6124, which the predicate also met.)
Biocompatibility
Irritation	Not an irritant (ISO 10993-10)	Under the conditions of the study, not an irritant
Sensitization	Not a sensitizer (ISO 10993-10)	Under conditions of the study, not a sensitizer.
Cytotoxicity	Not cytotoxic (ISO 10993-5)	Under conditions of the study, not cytotoxic

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many gloves were tested for tensile strength, elongation, or freedom from holes). However, it refers to industry standards (ASTM D5151, ASTM D5250, ASTM D6124) which inherently define sampling plans for these tests. For instance, ASTM D5151 specifies an Acceptance Quality Limit (AQL) of 1.5, which implies a specific sampling size based on lot size for hole detection.

The data provenance is not explicitly stated in terms of country of origin for the testing itself, but given the submitter's address in China, it's reasonable to infer the testing took place there. The studies are retrospective in the sense that they are post-manufacturing tests performed on the finished product according to established standards.

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 Vinyl Patient Examination Gloves is primarily established by objective, quantifiable physical and chemical properties and biological safety assessments derived from standardized laboratory tests. There is no subjective assessment by medical experts required to determine if a glove has a specific tensile strength or is free from holes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretation (e.g., image reading) where multiple experts might disagree on an assessment. For objective laboratory tests, the results are quantitative and do not require expert adjudication in this manner.

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 is not applicable. This is a submission for an examination glove, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessment of AI assistance for human readers are irrelevant.

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

This is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on objective, quantitative laboratory measurements and biological testing results as defined by recognized consensus standards (ISO 10993-10, ISO 10993-5, ASTM D6124, ASTMD5151, ASTM D5250). For example:

Physical Properties: Measured tensile strength and ultimate elongation against specified minimums.
Freedom from Holes: Determined by standardized water leak tests (e.g., based on ASTM D5151).
Powder Content: Measured gravimetrically according to ASTM D6124.
Biocompatibility: Determined by in vitro and in vivo toxicology tests for irritation, sensitization, and cytotoxicity according to ISO 10993 standards.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning. The "training" for such devices involves adherence to manufacturing process controls and validated testing methods to ensure consistent product output.

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

This is not applicable as there is no "training set" for this type of device. The ground truth for evaluating the device's performance is established by the specified requirements in the referenced international and ASTM standards.

Summary

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October 6, 2018

Jiangxi Zhonghong Pulin Medical Products Co., Ltd % Boyle Wang Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai. 200120 Cn

Re: K182117

Trade/Device Name: Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 20, 2018 Received: August 6, 2018

Dear Boyle Wang:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Tina Kiang, Ph.D. Acting 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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510(k) Summary K182117

This summary of 510(k) information is in accordance with 21 CFR 807.92.

1.0 submitter's information

Name: Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. Address: Yinsha Wan Industrial Park, High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province Phone Number: +86-315-4168700 Contact: Joe Zhang Date of Preparation: 10/3/2018

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel:+86-18930777676, Fax:+86-21-50313932 Email: Info@truthful.com.cn

2.0 Device information

Trade name: Vinyl Patient Examination Gloves

Vinyl Patient Examination Gloves (Powder Free) Common name:

Regulation name: Non-Powdered Patient Examination Glove

Model(s): XS, S, M, L, XL 3.0 Classification

Production code: LYZ Regulation number: 21 CFR 880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate device information

Manufacturer: Hebei Hongtai Plastic Products Company Limited

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Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168

5.0 Intended use

The Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.

The intended use and the indication for use of Vinyl Patient Examination Glove, as described in its labeling are the same as the predicate device Vinyl Patient Examination Gloves (White, Blue, Yellow) (K163168).

6.0 Device description

7.0 Technological Characteristics Comparison Table

Table1-General Comparison
Item	Proposed device	Predicated device	Remark
Product Code	LYZ	LYZ	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Indications for Use	The Vinyl PatientExamination Glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner ' s hands toprevent contaminationbetween patient andexaminer.	The Vinyl ExaminationGlove (White, Blue, orYellow) is a disposabledevice intended formedical purposes thatis worn on theexaminer's hands toprevent contaminationbetween patient andexaminer.	Same
Powdered or Powered free	Powdered free	Powdered free	Same
Design Feature	ambidextrous	ambidextrous	Same
Surface Feature	Smooth	Smooth	Same
Labeling Information	Single-use indication	Single-use indication	Same

Table1-General Comparison

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powder free, device color,device name, glove sizeand quantity, VinylExamination Gloves,Non-Sterile	powder free, devicecolor, device name,glove size and quantity,Vinyl ExaminationGloves, Non-Sterile
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Table2 Device Dimensions Comparison

Predicate	Designation	Size				Tolerance
Device(K163168)		XS	S	M	L	XL
	Length, mm	230	230	235	245	245	min
	Width, mm	80	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05				min
	Palm	0.08				min
Proposed Device	Designation	Size				Tolerance
		XS	S	M	XS	S
	Length, mm	230	230	235	245	245	min
	Width, mm	80	85	95	105	115	±5
	Thickness, mm:
	Finger	0.05				min
	Palm	0.08				min
Remark		SAME

Table3 Performance Comparison

Item			Proposed device	Predicated device	Remark
Colorant			Clear, Non-Colored	White, Blue, Yellow	Analysis1
PhysicalProperties	BeforeAging	TensileStrength	15MPa, min	15MPa, min	SAME
		UltimateElongation	380%min	380%min	SAME
	AfterAging	TensileStrength	15MPa, min	15MPa, min	SAME
		UltimateElongation	380%min	380%min	SAME
		Comply with ASTM D5250	Comply with ASTM D5250	Comply with ASTM D5250	SAME
Freedom from Holes			Be free from holes when tested in accordance with ASTMD5151 AQL=1.5	Be free from holes when tested in accordance with ASTMD5151 AQL=1.5	SAME
Powder Content			0.48	Meet the requirements of ASTM D6124	SIMILAR

Analysis1: The proposed device has a different color in comparison to the predicate device. The difference in color of the subject device did not raise a safety concern because biocompatibility test results were passing for the subject device.

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Item	Proposed device	Predicated device	Remark
Material	Vinyl	Vinyl	SAME
Biocompatibility	Irritation	Under the conditions of the study, not an irritant	Comply with ISO10993-10	SAME
	Sensitization	Under conditions of the study, not a sensitizer.
	Cytotoxicity	Under conditions of the study, not cytotoxic	/	SIMILAR
Label and Labeling		Meet FDA's Requirement	Meet FDA's Requirement	SAME

Table4 Safety Comparison

8.0 Discussion of non-clinical and clinical test performed

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

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves

ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

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 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.