The BLUE VINYL EXAMINATION GLOVES 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, BLUE VINYL EXAMINATION GLOVES 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 BLUE VINYL EXAMINATION GLOVES POWDER FREE, and includes variations of different size.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for "BLUE VINYL EXAMINATION GLOVES POWDER FREE." This document aims to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not applicable to this document.

This document focuses on demonstrating that the proposed medical device (examination gloves) is substantially equivalent to a legally marketed predicate device based on material, intended use, dimensions, physical properties, and biocompatibility, as per FDA regulations for Class I devices. The "bench tests" mentioned are used to verify compliance with specified ASTM and ISO standards for physical properties and freedom from holes, typical for such devices, rather than a clinical study evaluating diagnostic performance.

However, I can extract the 'acceptance criteria' as presented for the physical and biocompatibility properties of the gloves and the 'study' (bench tests and standards compliance) used to demonstrate these aspects. Please note these are not acceptance criteria in the context of an AI/algorithm study.

1. Table of Acceptance Criteria and Reported Device Performance

Item / Test	Acceptance Criteria (Proposed Device)	Reported Device Performance
Physical Properties (Before Aging)
Tensile Strength	13 MPa, min	13 MPa, min
Ultimate Elongation	400 % min	400 % min
Comply with ASTM D5250	Comply with ASTM D5250	Comply with ASTM D5250
Physical Properties (After Aging)
Tensile Strength	13 MPa, min	13 MPa, min
Ultimate Elongation	400 % min	400 % min
Comply with ASTM D5250	Comply with ASTM D5250	Comply with ASTM D5250
Freedom from Holes	Be free from holes when tested in accordance with ASTM D5151 (e.g., AQL for pinholes)	Be free from holes when tested in accordance with ASTM D5151
Powder Content	0.50 mg per glove	0.50 mg per glove (meets ASTM 5250 requirements)
Biocompatibility - Irritation	Not an irritant (as per ISO 10993-10)	Not an irritant
Biocompatibility - Sensitization	Not a sensitizer (as per ISO 10993-10)	Not a sensitizer

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

The document states "Bench tests were conducted to verify that the proposed device met all design specifications". Specific sample sizes for each test (e.g., for tensile strength, elongation, hole detection, powder content) are not provided in this summary, but would typically be defined within the referenced ASTM and ISO standards (e.g., ISO 2859-1 for sampling by attributes, often used for AQL testing).
Data provenance: The tests were conducted internally by ZIBO SANYING TRADE CO., LTD or a contracted lab in China. The data would be prospective for the specific batch of gloves tested.

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 in the context of an AI/algorithm study. For glove testing, "ground truth" would be the objective measurement results from standardized laboratory equipment and methods. Expert interpretation (beyond performing the test according to standard) is not typically a factor.

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

Not applicable. Glove performance tests are objective measurements, not subject to adjudicative processes like clinical assessments.

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 is not an AI-driven device.

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

Not applicable. This is not an AI-driven device.

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

The "ground truth" for the glove's performance is based on objective physical and chemical measurements against established industry standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10). For example, a "hole" is objectively detected using the ASTM D5151 method; tensile strength is a measured value; powder content is weighed.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device; there is no "training set."

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

Not applicable. There is no training set.

Summary

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

May 12, 2015

ZIBO SANYING TRADE CO., LTD C/O 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: K150224 Trade/Device Name: Blue Vinyl Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Vinyl Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 29, 2015 Received: April 1, 2015

Dear Mr. 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.

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Page 2 - Mr. Wang

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

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Section II Indications for Use

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150224

Device Name

BLUE VINYL EXAMINATION GLOVES POWDER FREE

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
▢ Prescription Use (Part 21 CFR 801 Subpart D)	☑ Over-The-Counter Use (21 CFR 801 Subpart C)

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Section III 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: K150224

1. Date of Preparation: 2015/1/30
1. Sponsor

ZIBO SANYING TRADE CO., LTD XILV VILLAGE FANGZHEN , ZHANGDIAN DISTRICT, ZIBO , SHANDONG , 255000 , CHINA

Contact Person: Ms. Jing Li Tel: +86- 0533-3819144 Fax: +86-0533-3818127 Email: hclijing85@126.com

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
1. Proposed Device Identification

Trade Name: BLUE VINYL EXAMINATION GLOVES 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

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Intended Use Statement:

1. Predicate Device Identification
  510(k) Number: K142508 Product Name: Powder Free Yellow Vinyl Examination Gloves Manufacturer: Zibo HUAQI TRADING Co., Ltd.

6. Device Description

The proposed is BLUE VINYL EXAMINATION GLOVES POWDER FREE, 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.

Substantially Equivalent Comparison Conclusion 8.

ITEM	Proposed Device	Predicate Device (K142508)	Remark
BLUE VINYL EXAMINATION GLOVES		Powder Free Yellow Vinyl

Table 1 General Comparison

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	POWDER FREE	Patient Examination Gloves
Product Code	LYZ	LYZ	SE
Regulation No.	21 CFR 880.6250	21 CFR 880.6250	SE
Class	I	I	SE
Intended Use	The BLUE VINYL EXAMINATIONGLOVES POWDER FREE is a disposabledevice intended for medical purposes that isworn on the examiner's hands or finger toprevent contamination between patient andexaminer.	The Powder Free Yellow VinylPatient Examination Gloves is a disposabledevice intended for medical purposes that isworn on the examiner's hands or finger toprevent contamination between patient andexaminer.	SE
Powdered orPowered free	Powdered free	Powdered free	SE

Table 2 Device Dimensions Comparison
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	Size					Tolerance
	Designation	S	M	L	XL
	Proposed DeviceBLUE VINYL EXAMINATIONGLOVES POWDER FREE	Length, mm	240	240	240		240
Width, mm		85	95	105	115	±5
Thickness, mm:
	Finger	0.10				min
	Palm	0.08				min
	Cuff	0.06				min
Predicate Device (K142508)Powder Free Yellow VinylPatient Examination Gloves	Designation	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
	Cuff	0.06				min
Remark	SE

Table 3 Performance Comparison

ITEM	Proposed Device	Predicate Device (K142508)	Remark
	BLUE VINYL EXAMINATION	Powder Free Yellow Vinyl
	GLOVES POWDER FREE	Patient Examination Gloves
Colorant	Blue	Yellow	Analysis
PhysicalProperties	BeforeAging	TensileStrength	13 MPa, min	13 MPa, min	SE
		UltimateElongation	400 % min	400 % min	SE
	After	Tensile	13 MPa, min	13 MPa, min	SE

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	Strength
	UltimateElongation	400 % min	400 % min	SE
		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 4 Safety Comparison

ITEM	Proposed Device	Predicate Device (K142508)	Remark
	BLUE VINYL EXAMINATIONGLOVES POWDER FREE	Powder Free Yellow VinylPatient Examination Gloves
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 a sensitizer
Label and Labeling		Meet FDA's Requirements	Meet FDA's Requirements	SE

The color of the proposed device is different from the color of the predicate device. This difference may potentially cause biocompatibility issues. In order to mitigate this risk, we conducted biocompatibility tests according to ISO 10993-10 and the test results demonstrated that the proposed device with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization.

The proposed device, BLUE VINYL EXAMINATION GLOVES POWDER FREE, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.

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.