The Vinyl Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device is Powder Free Vinyl Patient Examination Gloves. The colors of proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

AI/ML Overview

This document is a 510(k) summary for a Vinyl Examination Glove (Clear, Non-Colored). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested items (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, how ground truth for training/test set was established, effect size for human readers with/without AI, standalone performance) are not applicable to this submission, as it's for a medical glove, not an AI/ML device.

However, I can extract the acceptance criteria and performance data related to the glove's physical and biological properties and summarize what is available from the document:

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

Item / Test	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed Device)	Remark
General
Product Code	LYZ	LYZ	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	SAME
Intended Use	Prevent contamination between patient and examiner.	Prevent contamination between patient and examiner.	Similar
Powdered or Powdered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	SAME
Labeling Information	Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile	Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile	SAME
Colorant	White, Blue, Yellow	Clear, Non-Colored	Analysis 1
Physical Properties (Before Aging)
Tensile Strength	15 MPa, min	15 MPa, min	SAME
Ultimate Elongation	380 % min	380 % min	SAME
Physical Properties (After Aging)
Tensile Strength	15 MPa, min	15 MPa, min	SAME
Ultimate Elongation	380 % min	380 % min	SAME
Compliance to ASTM D5250	Comply with ASTM D5250	Comply with ASTM D5250	SAME
Freedom from Holes	Be free from holes when tested in accordance with ASTM D5151 AQL=1.5	Be free from holes when tested in accordance with ASTM D5151 AQL=1.5	SAME
Powder Content	Meet the requirements of ASTM 5250	0.4 mg	Similar
Biocompatibility
Irritation	Not an irritant	Under the conditions of the study, not an irritant	Comply with ISO 10993-10
Sensitization	Not a sensitizer	Under conditions of the study, not a sensitizer.	Comply with ISO 10993-10
Cytotoxicity	Did not show potential toxicity to L-929 cells	Under conditions of the study, did not show potential toxicity to L-929 cells.	Comply with ISO 10993-5
Material & Labeling
Material	Vinyl	Vinyl	SAME
Label and Labeling	Meet FDA's Requirements	Meet FDA's Requirements	SAME

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document implies testing was performed according to standards like ASTM D5151 for "Freedom from Holes" which specifies sampling procedures (AQL=1.5, per ISO 2859-1:1999). However, the specific sample sizes used for each test (Tensile Strength, Elongation, etc.) are not explicitly stated in this summary.
Data provenance (country of origin, retrospective/prospective) is not specified for the non-clinical tests.

3. 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 not an AI/ML device requiring expert ground truth in that context. The "ground truth" for the glove relates to its physical and biological properties as measured by standard methods.

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

Not applicable. This is not an AI/ML device requiring expert adjudication.

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. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

For the physical properties (tensile strength, elongation, freedom from holes, powder content) and biocompatibility (irritation, sensitization, cytotoxicity), the "ground truth" is established by adherence to recognized international and ASTM standards (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5). These standards define appropriate test methods and acceptance criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a "training set."

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 13, 2018

Zhicheng Trading Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn

Re: K180861

Trade/Device Name: Vinyl Examination Glove (Clear, Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: March 30. 2018 Received: April 2, 2018

Dear Ray 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. 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

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801); medical device 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.

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 medical devices and radiation-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,

Elizabeth F. Claverie -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180861

Device Name Vinyl Examination Glove (Clear, Non-Colored)

Indications for Use (Describe)

The Vinyl Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

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

This 510(k) Summary is being submitted in accordance with requirements in 21 CFR 807.92.

The assigned 510(k) Number: K180861

1. Date of Preparation:2018/05/14
1. Sponsor Identification

ZHICHENG TRADING CO., LTD.

NORTH, BEIJING ROAD, ZHANGDIAN DISTRICT, ZIBO CITY, CHINA 255000 Establishment Registration Number: Not yet registered

Contact Person: Chong Zhao Position:Sales Manager Tel: +86-533-3819144 Fax: +86-533-3819144

Email: hcsimon@126.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Tel: +86-18910677558, Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com

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1. Identification of Proposed Device
  Trade Name: Vinyl Examination Glove (Clear, Non-Colored) Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): S M L XL

Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification:I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Indication for use Statement:

The Vinyl Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description న.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The colors of proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

Identification of Predicate Device(s) 6.

Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited

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ITEM	Proposed Device	Predicate Device (K163168)	Remark
Product Code	LYZ	LYZ	SAME
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SAME
Class	I	I	SAME
Intended Use	The Vinyl Patient Examination Glove(Clear, Non-Colored) is a disposabledevice intended for medical purposes thatis worn on the examiner's hands to preventcontamination between patient andexaminer.	The Vinyl Examination Glove (White,Blue, or Yellow) is a disposable deviceintended for medical purposes that is wornon the examiner's hands to preventcontamination between patient andexaminer.	Similiar
Powdered orPowered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	SAME
LabelingInformation	Single-use indication, powder free, devicecolor, device name, glove size and quantity,Vinyl Examination Gloves, Non-Sterile	Single-use indication, powder free, devicecolor, device name, glove size and quantity,Vinyl Examination Gloves, Non-Sterile	SAME

Technological Comparison 7.

Table 1 General Comparison

Table 2 Device Dimensions Comparison

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

Table 3 Performance Comparison

ITEM			Proposed Device	Predicate Device (K163168)	Remark
Colorant			Clear, Non-Colored	White, Blue, Yellow	Analysis 1
PhysicalProperties	BeforeAging	TensileStrength	15 MPa, min	15 MPa, min	SAME

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		UltimateElongation	380 % min	380 % min
		TensileStrength	15 MPa, min	15 MPa, min
	AfterAging	UltimateElongation	380 % min	380 % min
			Comply with ASTM D5250	Comply with ASTM D5250	SAME
Freedom from Holes			Be free from holes when tested inaccordance with ASTM D5151AQL=1.5	Be free from holes when testedin accordance with ASTMD5151 AQL=1.5	SAME

Powder Content			0.4 mg	Meet the requirements of ASTM 5250	Similar

Table 4 Safety Comparison

ITEM	Proposed Device	Predicate Device (K163168)	Remark
Material	Vinyl	Vinyl	SAME
Biocompatibility	Irritation	Under the conditions of the study,not an irritant	Comply with ISO 10993-10	Similar
	Sensitization	Under conditions of the study, not asensitizer.
	Cytotoxicity	Under conditions of the study, didnot show potential toxicity to L-929cells. Complies with ISO 10993-5	/
Label and Labeling		Meet FDA's Requirements	Meet FDA's Requirements	SAME

Analysis 1:

The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown difference do not effect the safety of proposed device.

8. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications or acceptance criteria of the standards. The test results demonstrated that the proposed device met the design or acceptance criteria of 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

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ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-06 (Reapproved 2015), 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.
ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
Clinical Test Conclusion 9.

No clinical study is included in this submission.

1. 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 predicate 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.