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 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

The provided document describes a 510(k) premarket notification for a Vinyl Examination Glove (Clear, Non-Colored). This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices. The document explicitly states that clinical testing is not needed for this device (Page 7, Section 9). This means the study described is a non-clinical study focused on meeting established performance standards for examination gloves, rather than a clinical trial involving human patients or complex algorithms.

Therefore, many of the requested elements for describing a study that proves device acceptance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, training set sample size, ground truth for training set) are not applicable in this context.

Below is the information that can be extracted or inferred from the provided text regarding acceptance criteria and the non-clinical study that demonstrates the device meets these criteria.

Acceptance Criteria and Device Performance

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

Acceptance Criteria (Standard / ASTM Requirement)	Reported Device Performance (Proposed Device)	Remark
Physical Properties
Tensile Strength Before Aging: 15 MPa, min	15 MPa, min	SAME as predicate, complies with ASTM D5250
Ultimate Elongation Before Aging: 380 % min	380 % min	SAME as predicate, complies with ASTM D5250
Tensile Strength After Aging: 15 MPa, min	15 MPa, min	SAME as predicate, complies with ASTM D5250
Ultimate Elongation After Aging: 380 % min	380 % min	SAME as predicate, complies with ASTM D5250
Freedom from Holes (per ASTM D5151, AQL=1.5)	Be free from holes	SAME as predicate
Powder Content (limit)	0.5 mg (meets requirements of ASTM 5250)	SIMILAR to predicate (which states "Meet the requirements of ASTM 5250"), implies compliance
Dimensions (per ASTM D5250)
Length, mm (all sizes S, M, L, XL): min 230-245	S: 230, M: 235, L: 245, XL: 245	SAME as predicate
Width, mm (all sizes S, M, L, XL): $\pm$5	S: 85, M: 95, L: 105, XL: 115	SAME as predicate
Thickness, mm: Finger: min 0.05	0.05	SAME as predicate
Thickness, mm: Palm: min 0.08	0.08	SAME as predicate
Biocompatibility (per ISO 10993-10, ISO 10993-5)
Irritation	Not an irritant	SIMILAR to predicate, complies with ISO 10993-10
Sensitization	Not a sensitizer	SIMILAR to predicate, complies with ISO 10993-10
Cytotoxicity	Did not show potential toxicity to L-929 cells	SIMILAR to predicate, complies with ISO 10993-5
Labeling
Meet FDA's Requirements	Meets FDA's Requirements	SAME as predicate

Non-Clinical Study Information

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

Sample Size: The document does not specify the exact sample size for each test. However, standards like ASTM D5151 (Freedom from Holes) and ISO 2859-1 (Sampling Procedures for Inspection by Attributes) imply specific sampling methodologies and statistical sample sizes are used for these types of tests on manufacturing lots. For example, AQL=1.5 for freedom from holes suggests a defined sampling plan from a batch of gloves.
Data Provenance: The tests were conducted to verify design specifications and compliance with international standards (ISO, ASTM). The manufacturer is Huifu Trading Co., Ltd. in China. The tests are non-clinical, meaning they involve laboratory or bench testing of the physical device, not human subjects. It's a type of prospective testing against established standards.

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

Not Applicable. This is a non-clinical study for a Class I medical device (patient examination glove). "Ground truth" in the sense of expert consensus for medical interpretation or diagnosis is not relevant here. The "ground truth" is defined by established international and national standards (ASTM, ISO) for physical properties and biocompatibility.

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

Not Applicable. Adjudication methods are typically used in clinical studies or studies involving human assessment of data. For non-clinical tests on physical devices, the outcome is determined by adherence to specified test protocols and objective measurements against predefined acceptance limits in the 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 vinyl examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related comparative effectiveness are irrelevant.

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

Not Applicable. This device has no algorithmic component.

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

The "ground truth" is established by objective, quantitative specifications defined in international and national standards, such as:
- ASTM D5250: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
- ISO 2859-1: Sampling Procedures for Inspection by Attributes.

8. The sample size for the training set

Not Applicable. This is not a study involving machine learning or AI, so there is no concept of a "training set."

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

Not Applicable. As there is no training set, this question is irrelevant.

Summary

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June 11, 2018

Huifu 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 China

Re: K180849

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

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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); good manufacturing practice requirements as set forth in 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.

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.

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,

Geeta K. Pamidimukkala -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) K180849

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 Title 21, CFR Section 807.92.

The assigned 510(k) Number: K180849

1. Date of Preparation:2018/06/04
1. Sponsor Identification

HUIFU TRADING CO., LTD. NORTH, SHANGHAI ROAD, ZHANGDIAN DISTRICT, ZIBO CITY, CHINA 255000

Contact Person: Kangkang Wang Position:Sales Manager Tel: +86-533-3819144 Fax: +86-533-3819144

Email: victor821016@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:1 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 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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7.	Technological Comparison
----	--------------------------

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.	SIMILAR
Powdered orPowered free	Powdered free	Powdered free	SAME
Design Feature	ambidextrous	ambidextrous	SAME
Surface Feature	Smooth	Smooth	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

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				Tolerance
	Designation	S	M	L	XL
	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

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	TensileStrengthBefore	15 MPa, min	15 MPa, min
	Aging	UltimateElongation	380 % min	380 % min	SAME
	After	TensileStrength	15 MPa, min	15 MPa, min
	Aging	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			0.5 mg	Meet the requirements of ASTM5250	SIMILAR

Table 4 Safety Comparison

ITEM	Proposed Device	Predicate Device (K163168)	Remark
Material	Vinyl	Vinyl	SIMILAR
Biocompatibility	Irritation	Under the conditions of the study, not an irritant	Comply with ISO 10993-10	SIMILAR
	Sensitization	Under conditions of the study, not a sensitizer.
	Cytotoxicity	Under conditions of the study, did not show potential toxicity to L-929 cells.	/
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. 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

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Cytotoxicity

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.

Clinical testing is not needed for this device.

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.