The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The proposed device, Vinyl patient examination glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The proposed is Powder Free Vinyl Patient Examination Gloves without color, and includes variations of different size.

AI/ML Overview

The document describes a 510(k) premarket notification for a Vinyl Patient Examination Glove, Powder Free, and compares it to a predicate device. The information provided is primarily focused on demonstrating substantial equivalence based on physical properties, performance standards, and biocompatibility, rather than a clinical study evaluating a diagnostic or AI-powered device. Therefore, many of the requested categories related to AI/diagnostic device evaluation (e.g., human reader performance, effect size with AI assistance, training set details) are not applicable.

However, based on the provided text, I can extract the acceptance criteria and performance data related to the physical characteristics and safety of the glove.

Here's the breakdown of the available information:

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

Criteria	Acceptance Criterion (Standard)	Proposed Device Performance	Predicate Device Performance	Remark/Compliance
Dimensions
Length (S, M, L, XL)	≥ 230 mm (min) - implied by ASTM D5250 compliance	230 mm	240 mm	SE (meets ASTM D5250)
Width (S, M, L, XL)	± 5 mm (specific values not stated, but implied by ASTM D5250)	S: 85, M: 95, L: 105, XL: 115 (all ± 5 mm)	S: 85, M: 95, L: 105, XL: 115 (all ± 5 mm)	SE
Thickness (Finger)	≥ 0.05 mm (min) (ASTM D5250)	≥ 0.05 mm	0.10 mm	SE (meets ASTM D5250)
Thickness (Palm)	≥ 0.08 mm (min) (ASTM D5250)	0.08 mm	0.08 mm	SE (meets ASTM D5250)
Physical Properties (Before Aging)
Tensile Strength	11 MPa, min (ASTM D5250)	11 MPa, min	13 MPa, min	SE (meets ASTM D5250)
Ultimate Elongation	300 % min (ASTM D5250)	300 % min	400 % min	SE (meets ASTM D5250)
Physical Properties (After Aging)
Tensile Strength	11 MPa, min (ASTM D5250)	11 MPa, min	13 MPa, min	SE (meets ASTM D5250)
Ultimate Elongation	300 % min (ASTM D5250)	300 % min	400 % min	SE (meets ASTM D5250)
Freedom from Holes	Be free from holes when tested in accordance with ASTM D5151	Be free from holes when tested in accordance with ASTM D5151	Be free from holes when tested in accordance with ASTM D5151	SE
Powder Content	0.50 mg per glove (ASTM D6124 and ASTM D5250)	0.50 mg per glove	Meets ASTM D5250 requirements (specific value not given)	SE
Biocompatibility - Irritation	Not an irritant (ISO 10993-10)	Under the conditions of the study, not an irritant	Under the conditions of the study, not an irritant	SE (Comply with ISO 10993-10)
Biocompatibility - Sensitization	Not a sensitizer (ISO 10993-10)	Under conditions of the study, not a sensitizer	Under conditions of the study, not a sensitizer	SE (Comply with ISO 10993-10)

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

Sample Size for Test Set: The document references standards like ASTM D5151 and ISO 2859-1 for sampling procedures, but it does not explicitly state the specific number of gloves tested for each criterion in this submission. ISO 2859-1 provides "Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," meaning the actual sample size would depend on the lot size and the AQL specified for each test.
Data Provenance: The tests were conducted by the manufacturer, Xingyuan Plastic Products Co., Ltd., which is located in TangShan City, Hebei PROV., China. The document does not specify if the testing was performed on a sample from a specific country of origin, but it is implied to be from the manufacturer's production. The study is a retrospective bench test comparison for regulatory submission.

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 submission for a medical device (glove) based on physical and material properties, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is defined by meeting established engineering and safety standards.

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

Not applicable. No human adjudication is involved for physical property testing of a glove. The testing involves standardized laboratory 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

Not applicable. This device is not an AI-powered diagnostic tool, and no human reader study was performed.

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

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

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

The "ground truth" in this context is defined by industry standards and specifications (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10) for physical properties, performance, and biocompatibility of medical examination gloves. Compliance with these standards serves as the benchmark.

8. The sample size for the training set

Not applicable. This refers to a manufactured product and its testing, not an AI model requiring a training set.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

January 26, 2016

Xingyuan Plastic Products Co., Ltd. % Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CHINA

Re: K153159

Trade/Device Name: Vinyl Patient Examination Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 16, 2015 Received: December 18, 2015

Dear Mr. 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

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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 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 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. Division 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)

K153159

Device Name

Vinyl patient examination glove, Powder Free

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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

PSC Publishing Services (301) 443-6740

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Exhibit 2 510(k) Summary

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

The assigned 510(k) Number: K153159

1. Date of Preparation: 2016/01/26
1. Sponsor

XINGYUAN PLASTIC PRODUCTS CO.,LTD. #100,CHANGDA ROAD, SIGEZHUANG, LUANNAN COUNTY, TangShan City, Hebei PROV., 063503, CHINA Contact Person: Mr. Qiwei Xing Tel: +86- 0315-4167693 Fax: +86-0315-4168700 Email: danny@zhonghongpulin.cn

Submission Correspondent 3. Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. Tel: +86-21-50313932 Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
Proposed Device Identification 4.

Trade Name: Vinyl patient examination glove, Powder Free Device Name: Vinyl Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves

Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

Intended Use Statement: The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical

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purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

1. Predicate Device Identification
  510(k) Number: K150224 Product Name: BLUE VINYL GLOVES POWDER FREE Manufacturer: ZIBO SANYING TRADE CO., LTD
Device Description 6.
The proposed device, Vinyl patient examination glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The proposed is Powder Free Vinyl Patient Examination Gloves without color, and includes variations of different size.

1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.

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

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.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

1. Substantially Equivalent Comparison Conclusion

ITEM	Proposed Device	Predicated Device	Remark
	Vinyl patient examination glove, PowderFree	BLUE VINYL GLOVES POWDER FREEK150224
Product Code	LYZ	LYZ	SE
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SE
Class	I	I	SE

Table 1 General Comparison

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	The Vinyl patient examination glove,Powder Free, is a disposable deviceintended for medical purposes that is wornon the examiner's hands or finger toprevent contamination between patient andexaminer.	The BLUE VINYL GLOVES POWDERFREE is a disposable device intended formedical purposes that is worn on theexaminer's hands or finger to preventcontamination between patient andexaminer.
Intended Use			SE
Powdered orPowered free	Powdered free	Powdered free	SE
Design Feature	ambidextrous, smooth	ambidextrous, smooth	SE

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	Designation	Size				Tolerance
Proposed Device	Length, mm	S	M	L	XL
Vinyl patient examination glove,Powder Free	Length, mm	230	230	230	230	min
	Width, mm	85	95	105	115	±5
	Thickness, mm:
	Finger	≥ 0.05				min
	Palm	0.08				min
	Designation	Size				Tolerance
Predicate Device (K150224)BLUE VINYL GLOVESPOWDER FREE	Length, mm	S	M	L	XL
	Length, mm	240	240	240	240	min
	Width, mm	85	95	105	115	±5
	Thickness, mm:
	Finger	0.10				min
	Palm	0.08				min
Remark	Analysis 1

Table 2 Device Dimensions Comparison

Analysis 1:

Although the proposed device has different with the predicated device in thickness of finger and palm, but the specifications of proposed device meet the requirements of ASTM D5250.

So we consider this as the proposed device is SE with the predicate device.

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ITEM			Proposed DeviceVinyl patient examination glove,Powder Free	Predicated DeviceBLUE VINYL GLOVESPOWDER FREEK150224	Remark
Colorant			N/A	Blue	Analysis 2
PhysicalProperties	BeforeAging	TensileStrength	11 MPa, min	13 MPa, min	Analysis 3
		UltimateElongation	300 % min	400 % min
	AfterAging	TensileStrength	11 MPa, min	13 MPa, min
		UltimateElongation	300 % min	400 % min
			Comply with ASTM D5250	Comply with ASTM D5250	SE
Freedom from Holes			Be free from holes when tested inaccordance with ASTM D5151	Be free from holes when testedin accordance with ASTMD5151	SE
Powder Content			0.50 mg per glove	Meet the requirements of ASTM5250	SE

Table 3 Performance Comparison

Analysis 2:

The proposed device has no color rather than blue of the predicate device, this different may causes potential biocompatibility, for this risk we conducted the biocompatibility test according to the ISO 10993-10, the test results showed that the proposed devices did not induce skin irritation and showed no significant evidence of causing skin sensitization.

So we consider this as the proposed device is SE with the predicate device.

Analysis 3:

Although the proposed device has different with the predicated device in physical properties, but the specifications of proposed device meet the requirements of ASTM D5250.

So we consider this as the proposed device is SE with the predicate device.

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ITEM	Proposed Device	Predicated Device	Remark
	Vinyl patient examination glove,Powder Free	BLUE VINYL GLOVES POWDERFREEK150224
Material	Vinyl	Vinyl	SE
Biocompatibility	Irritation	Under the conditions of the study,not an irritant	Comply with ISO 10993-10	SE
	Sensitization	Under conditions of the study, not asensitizer.		SE
Label and Labeling	Single-use indication, powder free,device name, glove size and quantity,Vinyl Examination Gloves,Non-Sterile	Single-use indication, powder free,device name, glove size and quantity,Vinyl Examination Gloves,Non-Sterile	SE

Table 4 Safety Comparison

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the 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.