Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powder free vinyl patient examination glove, colored (yellow) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D5250-06(reapproved), except for sterility requirements.

AI/ML Overview

This document describes the 510(k) premarket notification for the "Powder free vinyl patient examination glove, colored (yellow)" (K160675). The submission aims to demonstrate substantial equivalence to a predicate device, the "White vinyl patient examination glove" (K143277) from Life safety products (Hui Zhou) Co., Ltd.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Subject Device, K160675)	Predicate Device Performance (K143277)	Comparison Comment
Dimensions
Length	$\geq$ 230mm	243mm	Substantially Equivalent
Width (S Size)	85±5mm	85mm	Substantially Equivalent
Width (M Size)	95±5mm	95mm	Substantially Equivalent
Width (L Size)	105±5mm	105mm	Substantially Equivalent
Width (XL Size)	115±5mm	115mm	Substantially Equivalent
Finger thickness	$\geq$ 0.05mm	0.05mm	Substantially Equivalent
Palm thickness	$\geq$ 0.08mm	0.08mm	Substantially Equivalent
Overall dimension	Meets ASTM D5250-06	Meets ASTM D5250-06	Substantially Equivalent
Physical Properties
Tensile strength	$\geq$ 11MPa	15.7MPa	Substantially Equivalent
Elongation	$\geq$ 300%	385%	Substantially Equivalent
Overall physical properties	Meets ASTM D5250-06	Meets ASTM D5250-06	Substantially Equivalent
Freedom from Pinhole	Pinhole = 0/200; AQL 2.5; Meets ASTM D5151-06	Pinhole = 10/500; AQL 1.5; Meets ASTM D5151-06	Substantially Equivalent
Powder Residual	Powder residual = 0.5mg per glove; Meets ASTM D5250-06 and D6124-06	Powder residual = 1mg; Meets ASTM D5250-06 and D6124-06	Substantially Equivalent
Cytotoxicity	Per ISO10993-5, under the conditions tested, the subject glove is non-cytotoxic.	Per ISO10993-5, under the conditions tested, the subject glove is non-cytotoxic.	Substantially Equivalent
Biocompatibility	Per ISO10993-10, under the conditions tested, the subject glove was non-sensitizing and non-irritating.	Per ISO10993-10, under the conditions tested, the subject glove was non-sensitizing and non-irritating.	Substantially Equivalent

Note: The "acceptance criteria" for the subject device are generally presented as meeting relevant ASTM and ISO standards, with specific values reported for the subject device's performance which are then compared to the predicate device's reported performance.

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

The document does not explicitly state a test set from a clinical study for the device, as this is a device clearance based on substantial equivalence to a predicate, heavily relying on non-clinical performance data and conformity to recognized standards.

For Freedom from pinholes, the subject device reported 0/200, implying a sample size of 200 gloves tested for pinholes. The predicate device reported 10/500, implying a sample size of 500 gloves.
For Powder residual, the measurement is "0.5mg per glove," which would typically be an average or maximum over a sampled number of gloves, but the specific sample size for this test is not provided.
Biocompatibility testing (Cytotoxicity, Sensitization, Irritation) involved testing samples of the subject device. The specific number of samples tested for these biocompatibility evaluations is not mentioned in the provided text.

Data Provenance: The document does not specify the country of origin for the testing data, but the manufacturer is based in China. The data would be retrospective relative to the 510(k) submission, as it represents tests already conducted to support the filing.

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

This information is not applicable as the device is a medical glove, and the evaluation relies on objective physical and chemical testing against established standards, not on expert interpretation of results like in diagnostic imaging. Ground truth for these types of devices is based on laboratory measurements and adherence to specified performance metrics.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is based on objective laboratory testing against performance standards, which does not involve subjective adjudication or consensus methods typically seen in clinical studies with human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This device is a patient examination glove, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant and not part of the submission for this type of device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is a physical medical device (glove), not an algorithm or software. Therefore, a standalone performance study in the context of AI algorithms is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Standardized laboratory measurements: Adherence to physical properties (length, width, thickness, tensile strength, elongation), freedom from pinholes, and powder residual, as defined by ASTM standards (D5250-06, D5151-06, D6124-06).
Biocompatibility testing results: Based on ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation), assessing the biological response of the device material.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI development.

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

Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply here.

Summary

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

August 2, 2016

Kaixing Plastic Products Co., Ltd. % Daniel Qiu Project Manager Lichen Commercial Information Consulting Co., Ltd. Room 1304, Building 8, Yuntai Rd. 453 Pudong New District, Shanghai, CN 200126

Re: K160675

Trade/Device Name: Powder free vinyl patient examination glove, colored (yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 24, 2016 Received: June 24, 2016

Dear Mr. Qiu:

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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

Tina Kiang, Ph.D. 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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Indications for Use

510(k) Number (if known) K160675

Device Name

Powder free vinyl patient examination glove, colored(yellow)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I, Submitter's information

Name: KAIXING PLASTIC PRODUCTS CO., LTD. Address: 1101 Tanggang Road Luannan County Tangshan City, Hebei Province China Contact person: Danny Xing Telephone: +86-315-4167693 Fax: +86-315-4168700

II. Date prepared

May 27, 2016

III, Device

Name of the device: Powder free vinyl patient examination glove, colored (yellow) Classification name: Patient examination glove Regulation class: 1 Regulation number: 21CFR 880.6250 Panel: General hospital Product code: LYZ

IV, Predicative device

K143277, White vinyl patient examination glove, Life safety products (Hui Zhou) Co., Ltd.

V, Device description

VI, Indication for use

VII, Summary of comparison of technological characteristics with the predicative device

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At a high level, the subject and predicative devices are based on the following same technological elements:

Description	Powder free vinyl patientexamination glove,colored(yellow)Subject device(K160675)	White vinyl patientexamination glove(non-sterile)Predicate device(K143277)	Comments
Intended use	Powder free vinyl patient examination glove, colored (yellow) is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.	Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner	SubstantiallyEquivalent
Material	Poly vinyl Chloride	Poly vinyl Chloride	SubstantiallyEquivalent
Sizes	S,M,L, XL	S,M,L,XL	SubstantiallyEquivalent
Single use	Yes	Yes	SubstantiallyEquivalent
Sterility	Non-sterile	Non-sterile	SubstantiallyEquivalent

There are no significant technological differences between the subject and predicate device:

Characteristics	Powder free vinyl patientexaminationcolored(yellow)	White vinyl patientexaminationglove(non-sterile)Predicate device(K143277)	Comments
Dimension	Length: $\geq$ 230mmWidth:S Size 85±5mmM Size 95±5mmL Size 105±5mmXL Size 115±5mmFinger thickness $\geq$ 0.05mmPalm thickness $\geq$ 0.08mmMeets ASTM D5250-06	Length: 243mmWidth:S Size=85mmM Size=95mmL Size=105mmXL Size=115mmFinger thickness=0.05mmPalm thickness=0.08mmMeets ASTM D5250-06	SubstantiallyEquivalent
Physical properties	Tensile strengthen $\geq$ 11MPaElongation $\geq$ 300%Meets ASTM D5250-06	Tensile strengthen=15.7MPaElongation=385%Meets ASTM D5250-06	SubstantiallyEquivalent
Freedom from pinholes	Pinhole=0/200AQL 2.5Meets ASTM D5151-06	Pinhole=10/500AQL 1.5Meets ASTM D5151-06	SubstantiallyEquivalent

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Powder residual	Powder residual=0.5mg pergloveMeets ASTM D5250-06 andD6124-06	Powder residual= 1mgMeets ASTM D5250-06 andD6124-06	SubstantiallyEquivalent
Cytotoxicity	Per ISO10993-5, under theconditions tested, the subjectglove is non-cytotoxic.	Per ISO10993-5, under theconditions tested, the subjectglove is non-cytotoxic.	SubstantiallyEquivalent
Biocompatibility	Per ISO10993-10, under theconditions tested, the subjectglove was non-sensitizing andnon-irritating.	Per ISO10993-10, under theconditions tested, the subjectglove was non-sensitizingand non-irritating.	SubstantiallyEquivalent

VIII, Performance data

The following performance data were provided in support of the substantial equivalence determination.

ASTM D5250-06
ASTM D5151-06
ASTM D6124-06

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA draft guidance Use of international standard ISO-10993, "Biological evaluation of medical device part 1: Evaluation and testing," dated April 23, 2013 and international standard ISO10993-1 "Biological evaluation of medical devices-part 1: Evaluation and testing within a risk management process," as recognized by FDA. The group of testing included the following tests:

Cytotoxicity
Sensitization
Irritation

The subject device is considered to be a surface device, contacting intact skin, for duration of less than 24hours.

IX, Conclusions

The Kaixing Plastic Products Co., LTD powder free vinyl patient examination glove, colored(yellow) is substantially equivalent to the predicate device, Lifestyle Safety Products, Co, LTD White vinyl patient examination glove (non-sterile). Based on the non-clinical tests performed, the subject device is as safe, as effective and performs as well as the legally marketed predicate device, Lifestyle Safety Products, Co, LTD White vinyl patient examination glove (non-sterile) cleared under K143277.

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.