Powder-Free Yellow Vinyl Patient Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

AI/ML Overview

The provided text describes the 510(k) summary for Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves (K152719). This document is a premarket notification for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria.

As such, the information you've requested regarding acceptance criteria, study details, ground truth, and sample sizes is framed within the context of meeting established ASTM (American Society for Testing and Materials) standards for patient examination gloves, rather than a standalone clinical study on the device's diagnostic performance. The device is a physical product (gloves) and not an AI/software device, so many of the questions regarding AI-specific studies (MRMC, standalone algorithm performance) are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves are primarily defined by adherence to specific ASTM standards and FDA regulations. The reported device performance is presented as meeting these standards.

Feature / Test	Acceptance Criteria (from ASTM/Regulation)	Reported Device Performance
Dimensions - Length	ASTM D5250-06 (Reapproved 2011): ≥230mm min.	230mm min for all sizes (Meets ASTM D5250-06)
Dimensions - Width (Small)	ASTM D5250-06 (Reapproved 2011): 80-90 mm	85-88 mm (Meets ASTM D5250-06)
Dimensions - Width (Medium)	ASTM D5250-06 (Reapproved 2011): 90-100mm	94-97 mm (Meets ASTM D5250-06)
Dimensions - Width (Large)	ASTM D5250-06 (Reapproved 2011): 100-110mm	103-106mm (Meets ASTM D5250-06)
Dimensions - Width (X-Large)	ASTM D5250-06 (Reapproved 2011): 110-120 mm	113-115 mm (Meets ASTM D5250-06)
Dimensions - Thickness (Finger)	ASTM D5250-06 (Reapproved 2011): 0.05mm min.	0.05mm min. (Meets ASTM D5250-06)
Dimensions - Thickness (Palm)	ASTM D5250-06 (Reapproved 2011): 0.08mm min.	0.08mm min. (Meets ASTM D5250-06)
Physical Properties (Before/After Aging) - Elongation	ASTM D5250-06 (Reapproved 2011): ≥300%	≥300% (Meets ASTM D5250-06)
Physical Properties (Before/After Aging) - Tensile Strength	ASTM D5250-06 (Reapproved 2011): ≥14MPa	≥14MPa (Meets ASTM D5250-06)
Freedom from Pinholes (Water Leak Test)	21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011); Inspection Level I, AQL 2.5	Meets criteria (implied by "Substantially equivalent" and general statement)
Residual Powder	ASTM D6124-06 (Reaffirmation 2011)	Results generated values below 2mg of residual powder (Meets criterion)
Biocompatibility (Skin Irritation/Sensitization)	ISO 10993-10:2002/Amd.1:2006 (for predicate); ISO 10993-10 Third Edition 2010-08-01 (for subject device)	Non-irritant and non-sensitizer (Meets criterion)

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

Sample Size: The document does not explicitly state the specific sample sizes for each test in the batch of gloves. It refers to meeting ASTM standards, which would imply that the testing followed the sampling methodologies outlined in those standards (e.g., AQL levels for pinhole testing).
Data Provenance: The tests are conducted on the manufactured "Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves" by Xinfu Medical Products Co., Ltd. The testing would be conducted in China (East of Lipingtuo, Luannan County, Tangshan City, 063502 Hebei Province, China) and are likely retrospective data from product testing batches.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable in the context of this device. The "ground truth" for these physical performance tests (e.g., glove dimensions, tensile strength, pinholes, residual powder) is established by adherence to quantitative and qualitative criteria defined within the referenced ASTM standards, not by expert consensus in a diagnostic sense. These tests are performed by laboratory technicians or quality control personnel using calibrated equipment and standardized procedures.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements or binary pass/fail based on established standards, not subjective assessments requiring 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

Not applicable. This device is a physical medical glove, not an AI/software device. Therefore, no MRMC study or AI performance evaluation was conducted.

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

Not applicable. This device is a physical medical glove, not an AI/software device. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is the adherence to the quantitative and qualitative specifications outlined in the referenced ASTM standards and FDA regulations. For example:

Dimensions: Measured values must fall within the ranges specified by ASTM D5250-06.
Tensile Strength/Elongation: Measured values must meet or exceed the minimum requirements of ASTM D5250-06.
Freedom from Pinholes: The number of pinholes in a sample must meet the Acceptable Quality Level (AQL) of 2.5 per ASTM D5151-06 and 21 CFR 800.20.
Residual Powder: The measured powder residue must be below the limit specified by ASTM D6124-06 (below 2mg).
Biocompatibility: Results from established biological tests (e.g., ISO 10993-10) must indicate non-irritancy and non-sensitization.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/machine learning model that requires a training set. The compliance is based on testing production samples against established standards.

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

Not applicable, as there is no training set for a physical product like a patient examination glove.

Summary

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

March 1, 2016

Xinfu Medical Products Co., Ltd. c/o Mr. Chu Xiaoan Room 1606 Bldg. 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian Dis Beijing 100083 CHINA

Re: K152719

Trade/Device Name: Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 15, 2016 Received: January 19, 2016

Dear Mr. Xiaoan:

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 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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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.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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 Keith, M.S. 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) K152719

Device Name

Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves

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)

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Section C

510(k) Summary

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

"The assigned 510(k) number is: _

Premarket Notification [510(k)] Summary

[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

Submitter's name :	Xinfu Medical Products Co.,Ltd.
Submitter's address :	East of Lipingtuo, Luannan County, Tangshan City,063502 Hebei Province ,China
Phone number :	(86)315-4431166
Fax number :	(86)315-4431333
Name of contact person:	Xie Wenxing
Date the summary was prepared:	2016-03-01

[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Device Name:	Powder-Free Yellow Vinyl Patient Examination Gloves
Proprietary/Trade name:	"Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves"
Common Name:	Patient ex amination glove
Classification Name:	Patient ex amination glove
Device Classification:	I
Regulation Number:	21 CFR 80.6250
Panel:	General Hospital (80)
Product Code:	LYZ

[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .

Class I* Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).

Predicate device: Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.

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[(a)(4)] A description of the device

Device Description: Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

-- How the device functions:

PVC films form a barrier to body fluids and bloodborne Pathogens

-- Scientific concepts that form the basis for the device

The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

-- Physical and performance characteristics such as design, materials and physical properties:

PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

[(a)(5)] The summary describes the intended use of the device

Device Intended Use: Powder-Free Yellow Vinyl Patient Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.

Features & Description	Predicate Device	Subject Device	Result of Comparison
Company	Hebei Leader Plastic Co., Ltd.	Xinfu Medical Products Co.,Ltd.	--
510(K) Number	K122920	K152719
Product name	Powder Free Vinyl Patient Examination Gloves. Colored (Yellow)	Powder-Free Yellow Vinyl Patient Examination Gloves	Same
Product Code	LYZ	LYZ	Same
Size	Small/ Medium/ Large/X large	Small/ Medium/ Large/X large	Substantially equivalent
Intend for use	Powder Free Vinyl Patient Examination Gloves. Colored (Yellow) 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.	Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves 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.	Substantially equivalent
Device Description and Specifications	Meets ASTM D5250-06 (Reapproved 2011)	Meets ASTM D5250 -06 (Reapproved 2011)	Substantially equivalent
Dimensions -- Length	Meets ASTM D5250-06 (Reapproved 2011)	Meets ASTM D5250-06 (Reapproved 2011)	Substantially equivalent
	≥230mm min.	230mm min for all sizes
Dimensions -- Width	Meets ASTM D5250-06 (Reapproved 2011)Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm	Meets ASTM D5250-06 (Reapproved 2011)Small 85-88 mmMedium 94-97 mmLarge 103-106mmX large 113-115 mm	Substantially equivalent
Dimensions-- Thickness	Meets ASTM D5250-06(Reapproved 2011)	Meets ASTM D5250-06(Reapproved 2011)
	Finger 0.05mm min.Palm 0.08mm min.	Finger 0.05mm min.Palm 0.08mm min.
Physical Properties	Meets ASTM D5250-06(Reapproved 2011)	Meets ASTM D5250-06(Reapproved 2011)	Substantiallyequivalent
	Before aging/after agingElongation ≥300%Tensile Strength≥14MPa	Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa
Freedom fromPinholes	Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011)	Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011)HolesInspection Level IAQL2.5	Substantiallyequivalent
Residual Powder	Meets ASTMD6124-06(Reaffirmation2011)	ASTM D6124-06(Reaffirmation 2011)Results generated valuesbelow 2mg of residual powder	Substantiallyequivalent
Compare allmaterials used tofabricate thedevices	PVC	PVC	Substantiallyequivalent
Dusting orDonning Powder:	PU	PU	Substantiallyequivalent
Dusting orDonning Powder:name	PU	Polyurethane	Substantiallyequivalent
Compareperformance datasupportingsubstantialequivalence	MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011)	MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011)	Substantiallyequivalent
Single Patient Use	Single Patient Use	Single Patient Use	Substantiallyequivalent
Biocompatibility	Under the conditions of thisstudy, the test article was anon-irritant andnon-sensitizer.SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006	Under the conditions ofthis study, the test articlewas a non-irritant andnon-sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01	Substantiallyequivalent
Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed.	-Powder Free-Devices color: Yellow-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot	-Powder Free-Devices color: Yellow-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot	Substantiallyequivalent

The Powder-Free Yellow Vinyl Patient Examination Gloves non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

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[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Vinyl Patient Examination Glovesmeet requirements per ASTM Powder-Free Yellow D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01.

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. [(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well as the legally marketed device identified in (a)(3).

It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and the Powder-Free Yellow Vinyl Patient Examination Gloves is as effective, and performs as well as the predicate device Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.

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.