Powder-free Clear Vinyl Patient Examination Gloves by Shenyi(Shandong) Plastic Products, Co.Ltd

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder-Free Clear Vinyl Patient Examination Gloves (K142892).

It's important to note that this document is a 510(k) summary for a Class I medical device (patient examination glove). For such devices, the FDA typically relies on performance standards and substantial equivalence to a predicate device rather than extensive clinical trials for approval.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ASTM Standards/Biocompatibility)	Reported Device Performance (K142892)
Physical Properties (ASTM D5250-06)
Length on Large Size	Conform to ASTM D5250, 2011
Width of Palm on Large Size	Conform to ASTM D5250, 2011
Palm Thickness	Conform to ASTM D5250, 2011
Fingertip Thickness	Conform to ASTM D5250, 2011
Before & After Aging: Tensile Strength (Mpa)	≥11MPa (Tensile strength) (Conform to ASTM D5250-06)
Before & After Aging: Ultimate Elongations	≥360% (elongation) (Conform to ASTM D5250-06)
Barrier Properties (ASTM D5151-06)
Pinhole Results	AQL 2.5 (Conform to ASTM D5151-06)
Residual Powder (ASTM D6124)
Residual Powder	< 2 mg per glove (Conform to ASTM D6124)
Biocompatibility (ISO 10993-10)
Primary Skin Irritation	Not an irritant under the condition of study
Dermal Sensitization	Not a sensitizer under the condition of study

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document specifies that "The dimensions and physical properties tests followed ASTM D5250-06 and met AQL 2.5, inspection level S-2." and "The barrier test followed ASTM D5151-06 and met AQL 2.5, inspection level S-1." These AQL (Acceptable Quality Limit) levels refer to a sampling plan for inspection.
  - For physical properties (ASTM D5250-06) with AQL 2.5, inspection level S-2, the sample size would be determined by the specific batch size being tested according to the ASTM standard. For example, for a batch size of 50,001 to 150,000, inspection level S-2 uses a sample size of 80.
  - For barrier test (ASTM D5151-06) with AQL 2.5, inspection level S-1, the sample size would also be determined by the batch size. For a batch size of 50,001 to 150,000, inspection level S-1 uses a sample size of 50.
- Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer being in China. The tests are prospective in nature, as they are performed on the newly manufactured device to ensure it meets the specified standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is Not Applicable in the context of this device and study type. The "ground truth" for these tests are objective, measurable physical, chemical, and biological properties evaluated against established industry standards (ASTM, ISO). There is no "expert consensus" on classifications or interpretations of images, for example. The tests are performed by technicians following standard protocols.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is Not Applicable. The tests performed are objective measurements against defined pass/fail criteria from the ASTM and ISO standards. There is no subjective interpretation requiring adjudication among experts.
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 is Not Applicable. This document is for a medical glove, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is Not Applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests is based on objective measurements against established industry standards.
- For physical properties (tensile strength, elongation, dimensions), the ground truth is the values obtained from standardized mechanical tests.
- For barrier properties (pinholes), the ground truth is the number of defects found in a sample based on a standardized liquid integrity test.
- For residual powder, the ground truth is the measured mass of powder per glove.
- For biocompatibility (irritation, sensitization), the ground truth is the observable biological response in a standardized animal or in-vitro test model, assessed against predefined criteria for irritation/sensitization.
The sample size for the training set: This is Not Applicable. As this is not an AI/machine learning device, there is no "training set." The device is manufactured and tested against pre-defined specifications.
How the ground truth for the training set was established: This is Not Applicable for the reasons stated above.

Summary

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

March 25, 2015

Shenyi Shandong Plastic Products, Co. Ltd. C/O Mr. Ray Zhou Official Correspondent Basic Medical Industries, Inc. 12390 East End Ave. Chino, CA 91710

Re: K142892

Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 13, 2015 Received: February 23, 2015

Dear Mr. Zhou:

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. Zhou

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. 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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Indications for Use

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

510(k) Number (if known) K142892

Device Name

Powder-free Clear Vinyl Patient Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon 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)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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510(k) Summary

Submitter's Name and Address:

Shenyi (Shandong) Plastic Products, Co. Ltd. No.23 Fenghuang Road Fengshan Industry Park Linzi Shandong, 255400 China

Contact Person:

Minghao Shi, Marketing Manager Phone: # 86-533 7527018

Date Summary prepared: March 19, 2015

Name of the Device:

Powder-free Clear Vinyl Patient Examination Gloves

Assigned 510(k) Number

K142892

Common name/classification name of the Device:

Patient Examination Glove Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ

Predicate Device Information:

Device name: Vinyl Examination Gloves, Powder-Free 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd

Device Description:

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Indications for Use:

The subject device is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

Comparison to Predicate Devices:

Powder-free Clear Vinyl Patient Examination Gloves (K142892) is substantially equivalent to the Vinyl Examination Gloves, Powder-Free (K022091).

	Proposed Device (K142892)	Predicate Device (K022091)	COMMENTS
The device	Shenyi (Shandong) PlasticProducts, Co. Ltd. Powder-free Clear Vinyl PatientExamination Gloves	Vinyl Examination Gloves,Powder-Free TangshanZhonghong Pulin FoodProducts Co., Ltd
Regulation #	21 CFR 880.6250	21 CFR 880.6250	Substantiallyequivalent
Device Class	Class I	Class I	Substantiallyequivalent
Product Code:	LYZ	LYZ	Substantiallyequivalent
Indications forUse	Disposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner	Disposable device intendedfor medical purposes that isworn on the examiner's handor finger to preventcontamination betweenpatient and examiner	Substantiallyequivalent
Basic Design	Cover the hand and wrist area.Clovers have separate sheathsor openings for each fingerand the thumb.	Cover the hand and wristarea. Clovers have separatesheaths or openings for eachfinger and the thumb.	Substantiallyequivalent
Device Materials	Poly Vinyl Chloride	Poly Vinyl Chloride	Substantiallyequivalent
Residual Powder	<2 mg per gloveConform to ASTM D6124-06.	< 2 mg per gloveConform to ASTM D6124	Substantiallyequivalent
Length on LargeSize	Conform to ASTM D5250,2011	Conform to ASTM D52502002	Substantiallyequivalent
Width of Palm onLarge Size	Conform to ASTM D5250,2011	Conform to ASTM D52502002	Substantiallyequivalent
Palm Thickness	Conform to ASTM D5250,2011	Conform to ASTM D52502002	Substantiallyequivalent
FingertipThickness	Conform to ASTM D5250,2011	Conform to ASTM D52502002	Substantiallyequivalent

Substantial Equivalence Comparison Table

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Before & AfterAging: TensileStrength(Mpa)and UltimateElongations	≥11MPa (Tensile strength)≥360% (elongation)Conform to ASTM D5250-06	≥11MPa (Tensile strength)≥360% (elongation)Conform to ASTM D5250	Substantiallyequivalent
Pinhole Results	AQL 2.5Conform to ASTM D5151-06	AQL 2.5Conform to ASTM D5151	Substantiallyequivalent
Primary SkinIrritationPer ISO-10993-10	Not an irritant under thecondition of study	Not an irritant under thecondition of study	Substantiallyequivalent
DermalSensitizationPer ISO-10993-10	Not a sensitizer under thecondition of study	Not a sensitizer under thecondition of study	Substantiallyequivalent
Labeling	Labels include: Product name;Non-sterile; color; "single useOnly" size, Quantity,ambidextrous, lot number,distributor name, indicationfor use and manufactureraddress.	Labels include: Productname; Non-sterile; color;"single use" size, Quantity,ambidextrous, distributorname, indication for use andmanufacturer address.	Substantiallyequivalent
Substantialequivalence	The subject device in K142892, Powder-free Clear Vinyl Patient ExaminationGloves, has similar indications for use, design, material, physical and barrierproperties and Biocompatibility and is substantially equivalent to the predicatedevice (K022091).

Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:

Non-clinical tests were conducted on the subject device.

The dimensions and physical properties tests followed ASTM D5250-06 and met AQL 2.5, inspection level S-2.

The barrier test followed ASTM D5151-06 and met AQL 2.5, inspection level S-1. Residual powder test followed ASTM D6124 and met the requirement of powder-free glove.

Biocompatibility test followed ISO 10993-10 showing no primary skin irritation or sensitization, under the conditions of study.

The subject device met the requirements of non-clinical tests, and performed similar to the predicate device.

Sterilization

The subject device is non-sterile examination gloves for single use.

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Discussion of Clinical Tests Performed:

Not Applicable

Conclusions:

Powder-free Vinyl Patient Examination Glove, the subject device in K142892, has similar Indications for Use and technological characteristics, and is substantially equivalent to the predicate device (K022091).

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.