The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

AI/ML Overview

This document is a 510(k) summary for Hebei Grandeast Plastic Products Co., Ltd.'s Powder-free PVC Vinyl Exam Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

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

Study to Prove Device Meets Acceptance Criteria:

A non-clinical test study was conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device. The test results demonstrated compliance with the following standards:

ASTM D5250-06 (Reapproved 2011): Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application. This standard covers general requirements for dimensions, physical properties (tensile strength, elongation), and freedom from holes.
ASTM D5151-06 (Reapproved 2011): Standard Test Method For Detection Of Holes In Medical Gloves. This standard specifies the method for testing for holes.
ASTM D6124-06 (Reaffirmation 2011): Standard Test Method For Residual Powder On Medical Gloves. This standard specifies the method for testing the amount of residual powder.
ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. This standard governs biocompatibility testing.

The document indicates that the proposed device complies with all these standards and their specific requirements, thereby demonstrating that it meets the acceptance criteria.

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

The document does not explicitly state the specific sample sizes used for each test. It broadly states "Non clinical tests were conducted to verify that the proposed device met all design specifications..." The data provenance is implied to be from Hebei Grandeast Plastic Products Co., Ltd. in Julu County, Hebei Province, China, where the device manufacturer is located. The nature of these tests (e.g., laboratory testing of physical and chemical properties) would inherently be prospective for the specific batches tested to support the 510(k) submission.

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)

This section is not applicable to this type of device (patient examination gloves). The "ground truth" for medical gloves is established by objective, standardized laboratory tests against recognized ASTM and ISO standards, not by expert human interpretation or consensus.

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

This section is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, often in imaging or clinical trials. The tests for medical gloves are objective and rely on standardized measurement techniques.

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

This section is not applicable. MRMC studies are used to evaluate the performance of diagnostic devices often involving human readers and interpretations, especially in conjunction with AI. This document pertains to non-clinical testing of patient examination gloves.

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

This section is not applicable. This device is a physical medical glove, not a software algorithm or AI system.

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

The "ground truth" for this device is based on objective measurements and criteria defined in recognized international standards (ASTM and ISO) for physical properties (dimensions, tensile strength, elongation), functional performance (freedom from holes, residual powder), and biocompatibility (irritation, sensitization). These standards provide the accepted benchmarks for safety and effectiveness for patient examination gloves.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the same reason as point 8.

Summary

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

January 15, 2015

Hebei Grandeast Plastic Products Co., Ltd. C/O Ms. Diana Hong General Manager Mid- Link Consulting Co., Ltd. PO Box 120-119, Shanghai CHINA

Re: K142703

Trade/Device Name: Powder-Free PVC Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: December 15, 2014 Received: December 19, 2014

Dear Ms. Diana Hong:

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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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 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/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 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. 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)

K142703

Device Name

Powder-free PVC Vinyl Exam Gloves

Indications for Use (Describe)

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

മ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Tab #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 Title 21, CFR Section 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

1. Date of Submission: 01/06/2015
1. Sponsor Identification

Hebei Grandeast Plastic Products Co., Ltd. Industrial Park, Julu County, Hebei Province, China

Establishment Registration Number: Not yet registered

Contact Person: Wei Liu Position: Sale Manager Tel: 86-319-4362370 Fax: 86-319-4362371 Email: nedvidel@handform.cn

1. Submission Correspondent
  Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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1. Proposed Device Identification
  Proposed Device Name: Powder-free PVC Vinyl Exam Gloves Proposed Device Common Name: Powder-free Exam Gloves

Regulatory Information: Classification Name: Vinyl Patient Examination Glove: Classification: I; Product Code: LYZ; Regulation Number: 21 CFR 880.6250; Review Panel: General Hospital;

Intended Use Statement:

The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

1. Predicate Device Identification
  510(k) Number: K130733

Product Name: Benteng Power Free Vinyl Patient Examination Gloves, Clear (non-colored) Manufacturer: Benteng Plastic Co., Ltd.

Device Description 6.
The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
1. Non-Clinical Test Conclusion
  Non clinical 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 (Reapproved 2011), Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

ASTM D5151-06 (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 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin

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sensitization.

1. Substantially Equivalent (SE) Conclusion
  The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device(s)
Product Code	LYZ	LYZ
Regulation No.	21 CFR 880.6250	21 CFR 880.6250
Class	I	I
Intended Use	The Powder-free PVC Vinyl ExamGloves are disposable devices intendedfor medical purposes that are worn onthe examiner's hands or fingers toprevent contamination between patientand examiner.	Powder Free Vinyl PatientExamination Gloves, Clear(non-colored) is non-sterile disposabledevice intended for medical purposesthat is worn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner.
Powdered orPowered free	Powered free	Powered free
Size	S, M, L and XL	S, M, L and XL
DimensionsLength	Comply with ASTM D5250-06(Reapproved 2011)> 230 mm	Comply with ASTM D5250-06(Reapproved 2011)> 230 mm
DimensionsWidth	Comply with ASTM D5250-06(Reapproved 2011)S 85±5mmM 95±5mmL 105±5mmXL 115±5mm	Comply with ASTM D5250-06(Reapproved 2011)S 85±5mmM 95±5mmL 105±5mmXL 115±5mm
DimensionsThickness	Comply with ASTM D5250-06(Reapproved 2011)Palm 0.10±0.02mmFinger-tip 0.10±0.02mm	Comply with ASTM D5250-06(Reapproved 2011)Palm > 0.08mmFinger-tip > 0.05mm
Colorant	No colorant used	No colorant used
Single Use	Yes	Yes
PhysicalProperties	Before aging / after aging:Tensile Strength ≥ 11Mpa.	Before aging / after aging:Tensile Strength ≥ 11Mpa.

	Ultimate Elongation $\ge$ 300%Comply with ASTM D5250-06(Reapproved 2011)	Ultimate Elongation $\ge$ 300%Comply with ASTM D5250-06(Reapproved 2011)
Freedom fromHoles	Comply with ASTM D5250-06(Reapproved 2011) and ASTMD5151-06 (Reapproved 2011)	Comply with ASTM D5250-06(Reapproved 2011) and ASTMD5151-06 (Reapproved 2011)
Residue Powder	0.6 +/- 0.1 mg per gloveComply with ASTM D5250-06(Reapproved 2011)	$<$ 2mg per gloveComply with ASTM D5250-06(Reapproved 2011)
Compareperformance datasupportingsubstantialequivalence	Comply withASTM D5250-06 (Reapproved 2011),ASTM D5151-06 (Reapproved 2011),ASTM D6124-06 (Reaffirmation 2011)	Comply withASTM D5250-06 (Reapproved 2011),ASTM D5151-06 (Reapproved 2011),ASTM D6124-06 (Reaffirmation 2011)
Material	Main material: PVCLubricant: PU	Main material: PVCLubricant: PU
Biocompatibility	Sensitization	Under the conditions ofthis study, not asensitizer
	Irritation	Under the conditions ofthis study, not anirritant
		Comply with ISO 10993-10
Sterilization	Non-sterile	Non-sterile
Label andLabeling
		GuardFlex Powder Free PVC VinylExam Glovesnon sterilesingle use onlyManufacturer and addressLot No.Avoid excessive heatThis product is latex freeSize, Quantity, Manufacture Date,Indications for Use
		power free,patient examination glovedevices color: clear (non-colored)non sterilesingle use onlymanufactured forlot

Table 1 Comparison of Technology Characteristics

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The proposed devices, Powder-free PVC Vinyl Exam Gloves are determined to be Substantially Equivalent (SE) to the predicate devices, Benteng Power Free Vinyl Patient Examination Gloves, Clear (non-colored) (K130733), 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.

Test Parameter	Acceptance Criteria (Proposed Device)	Reported Device Performance (Proposed Device)	Acceptance Criteria (Predicate Device)	Reported Device Performance (Predicate Device)
Dimensions
Length	Comply with ASTM D5250-06 (Reapproved 2011): > 230 mm	Complies	Comply with ASTM D5250-06 (Reapproved 2011): > 230 mm	Complies
Width (S)	Comply with ASTM D5250-06 (Reapproved 2011): 85±5mm	Complies	Comply with ASTM D5250-06 (Reapproved 2011): 85±5mm	Complies
Width (M)	Comply with ASTM D5250-06 (Reapproved 2011): 95±5mm	Complies	Comply with ASTM D5250-06 (Reapproved 2011): 95±5mm	Complies
Width (L)	Comply with ASTM D5250-06 (Reapproved 2011): 105±5mm	Complies	Comply with ASTM D5250-06 (Reapproved 2011): 105±5mm	Complies
Width (XL)	Comply with ASTM D5250-06 (Reapproved 2011): 115±5mm	Complies	Comply with ASTM D5250-06 (Reapproved 2011): 115±5mm	Complies
Thickness (Palm)	Comply with ASTM D5250-06 (Reapproved 2011): 0.10±0.02mm	Complies	Comply with ASTM D5250-06 (Reapproved 2011): > 0.08mm	Complies
Thickness (Finger-tip)	Comply with ASTM D5250-06 (Reapproved 2011): 0.10±0.02mm	Complies	Comply with ASTM D5250-06 (Reapproved 2011): > 0.05mm	Complies
Physical Properties
Tensile Strength	Before aging / after aging: ≥ 11Mpa. Comply with ASTM D5250-06 (Reapproved 2011)	Complies	Before aging / after aging: ≥ 11Mpa. Comply with ASTM D5250-06 (Reapproved 2011)	Complies
Ultimate Elongation	Before aging / after aging: ≥ 300%. Comply with ASTM D5250-06 (Reapproved 2011)	Complies	Before aging / after aging: ≥ 300%. Comply with ASTM D5250-06 (Reapproved 2011)	Complies
Freedom from Holes	Comply with ASTM D5250-06 (Reapproved 2011) and ASTM D5151-06 (Reapproved 2011)	Complies	Comply with ASTM D5250-06 (Reapproved 2011) and ASTM D5151-06 (Reapproved 2011)	Complies
Residue Powder	0.6 +/- 0.1 mg per glove. Comply with ASTM D5250-06 (Reapproved 2011)	Complies	< 2mg per glove. Comply with ASTM D5250-06 (Reapproved 2011)	Complies
Biocompatibility
Sensitization	Not a sensitizer (implied by compliance with ISO 10993-10)	Complies	Under the conditions of this study, not a sensitizer (implied by compliance with ISO 10993-10)	Complies
Irritation	Not an irritant (implied by compliance with ISO 10993-10)	Complies	Under the conditions of this study, not an irritant (implied by compliance with ISO 10993-10)	Complies