A 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.

Device Description

Powder Free Vinyl Patient Examination Glove (Non-Sterile) is a patient examination glove available in S, M, L, XL. The glove is provided non-sterile and meets the entire requirement of ASTM standard D 5250-06.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device: "Powder Free Vinyl Patient Examination Glove (Non-Sterile)". The document outlines the device description, intended use, and a comparison to a predicate device.

However, the information requested in the prompt, specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is presented in a different context than typically found in AI/ML performance studies. This document pertains to the regulatory clearance of a physical medical device (examination gloves), not an algorithmic or AI-powered one.

Therefore, many of the requested fields are not applicable in this context. I will extract the relevant information regarding performance criteria and how the device meets them from the provided text.

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

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

Characteristics	Acceptance Criteria (Subject Device)	Reported Device Performance (Subject Device)
Dimension	Length: $\geq$ 230mm	Meets ASTM D5250-06.
	Width: S size=85mm $\pm$ 5mm; M size=95mm $\pm$ 5mm; L size=105mm $\pm$ 5mm; XL size=115mm $\pm$ 5mm	Meets ASTM D5250-06.
Thickness	Finger thickness $\geq$ 0.05mm	Meets ASTM D5250-06. (Implied, as the general statement "Meets ASTM D5250-06" covers these physical properties. The table formatting makes it seem like these are separate rows but they fall under the 'Dimension' and 'Physical Properties' characteristics for the subject device.)
	Palm thickness $\geq$ 0.08mm	Meets ASTM D5250-06. (Implied)
Physical Properties	Tensile strength $\geq$ 11MPa; Elongation $\geq$ 300%	Meets ASTM D 5250-06.
Freedom from pinholes	No leaks; AQL requirement: 2.5 with an accept/reject criteria of 2/3, sample size of 32 (Meets ASTM D5250-06)	Meets ASTM D5250-06.
Powder Residual	Powder residue $\leq$ 1.1; Meets ASTM D5250-06 and D6124-06	Meets ASTM D5250-06 and D6124-06.
Cytotoxicity	Not cytotoxic (ISO 10993-5: 2009)	Under the conditions of the study, not cytotoxic. The device passed all biocompatibility testing.
Biocompatibility	Not an irritant (Primary Dermal Irritation in rabbits, ISO 10993-10: 2010); Not a sensitizer (Dermal Sensitization in the guinea pig, ISO 10993-10: 2010)	Under the conditions of the study, not an irritant. Under conditions of the study, not a sensitizer. The device passed all biocompatibility testing. (Note: Only ISO 10993-10: 2010 is explicitly cited for irritation/sensitization in the table, but the text mentions ISO 10993-1 for overall biocompatibility evaluation, including irritation and skin sensitization tests.)

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set:
- For "Freedom from pinholes," the sample size is explicitly stated as 32.
- For other physical and material properties (dimension, tensile strength, elongation, powder residual), the sample sizes are not specified in the provided text, but it's implied that testing was conducted according to the respective ASTM standards.
- For biocompatibility tests, the sample sizes for animal tests (rabbits, guinea pigs) are not specified.
Data Provenance: The testing was conducted by or for LPL (HUI ZHOU) GLOVE CO., LTD in China, as stated by their address in the submitter information. The text does not specify whether the data is retrospective or prospective, but testing for regulatory submission typically involves prospective testing of manufacturing lots.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the evaluation of a physical medical device like examination gloves. "Ground truth" and "experts" in this context don't align with the AI/ML paradigm. The acceptance criteria are based on established international standards (ASTM, ISO) for physical and material properties and biological safety. Compliance is measured quantitatively.

4. Adjudication method for the test set

Not applicable. The evaluation is against objective, quantitative standards (e.g., specific dimensions, tensile strength values, AQL levels). There's no human "adjudication" in the sense of reconciling differing expert opinions.

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 a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

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

International Standards: Specifically, ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM 5151-06 (likely D5151, Standard Test Method for Detection of Holes in Medical Gloves).
Biocompatibility Standards: ISO 10993-5: 2009 (Cytotoxicity), ISO 10993-10: 2010 (Irritation and Skin Sensitization), and the general framework of ISO 10993-1.

These standards provide the quantitative and qualitative benchmarks against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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

December 21, 2015

LPL (Hui Zhou) Glove Co., Ltd. % Rhonda Alexander, M.S., M.P.A. Senior Regulatory Specialist Registrar Corp 144 Research Drive Hampton, Virginia 23666

Re: K150934

Trade/Device Name: Powder Free Vinyl Patient Examination Glove (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 25, 2015 Received: November 27, 2015

Dear Rhonda Alexander:

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

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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 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/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 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

Enclosure

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Indications for Use

510(k) Number (if known) K150934

Device Name

Powder Free Vinyl Patient Examination Glove (Non-Sterile)

Indications for Use (Describe)

A 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.

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

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UI ZHOU) GLOVE CO ..

地址: 中国广东省惠州市博罗县
罗阳镇大小塘村
电话: 0086-752-6863391
長真: 0086-752-6863392/3393
内页: www.lplglove.com
邮箱: Info@Iplglove.com

Daxiaotang village, Luoyang Town, Boluo County, Huizhou City, Guangdong Province, 516120 China. 0086-752-6863391 0086-752-6863392/3393 www.lplglove.com · Info@InIglove.com

510(k) Summary (21 CFR 807.92)

I. SUBMITTER

LPL (HUI ZHOU) GLOVE CO., LTD Daxiaotang Village, LuoYang Town, Boluo County Huizhou City, Guangdong Province 516120 China Tel: 00867526863391 Fax: 00867526863392 Email: info@lplglove.com Website: www.lplglove.com

Contact Person: Lee Hong Chong, Quality Assurance Date Prepared: December 8, 2015

II. DEVICE

Name of Device:	Powder Free Vinyl Patient Examination Glove (Non-Sterile)
Classification Name:	Patient Examination Glove
Regulatory Class:	Class I
Product Code:	LYZ
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital

III. PREDICATE DEVICE

Name of Device:	Powder Free Non-Sterile Vinyl Examination Glove
Manufacturer:	Jiangsu Sunshine Plastic Products Co., Ltd.
K Number:	K100978

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission. There have been no previous submissions.

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

A 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.

VI. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Powder Free Vinyl Patient Examination Glove (Non-Sterile) is compared with the following Predicate Devices in terms of intended use, design, material, specification, and performance.

K100978: Powder –Free Non-Sterile Vinyl Examination Glove, manufactured by Jiangsu (1) Sunshine Plastic Products Co., Ltd
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

Description	Subject Device	Predicate Device K100978
Indications for use	A patient examination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner.	The patient examination glove isa disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner.
	Vinyl Patient Examination Glove(Non-Sterile) K150934	Powder -Free Non-Sterile VinylExamination Glove
Material	Poly vinyl Chloride (PVC)	Poly vinyl Chloride (PVC)
Size	S, M, L, XL	S, M, L, XL
Single use	Yes	Yes
Sterile	Non-sterile	Non-sterile
Color	Clear	Clear

Table 5.1 Comparison of Intended Use, Design, and Material

The Powder Free Vinyl Patient Examination Glove (Non-Sterile) is summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Subject device	Predicate device
	K150934	K100978
Dimension	Length: $\geq$ 230mm	Meets	ASTM	D
	Meets ASTM D5250-06	5250-06
	Width:
	S size=85mm $\pm$ 5mm
	M size=95mm $\pm$ 5mm
	L size=105mm $\pm$ 5mm
	XL size=115mm $\pm$ 5mm

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Finger thickness≥0.05mm
Palm thickness≥0.08mm
Physical Properties	Tensile strength≥11MPaElongation≥300%Meets ASTM D 5250-06	Meets5250-06	ASTM	D
Freedom from pinholes	No leaks; meets ASTM D5250-06(AQL requirement: 2.5 with an accept/rejectcriteria of 2/3, sample size of 32)	Meets800.20	21	CFR

Powder Residual	Powder residue ≤1.1Meets ASTM D5250-06 and D6124-06	Meets ASTM D 5250-06
Cytotoxicity(ISO 10993-5: 2009)	Under the conditions of the study, not cytotoxic	N/A
Biocompatibility(ISO 10993-10: 2010)	Primary Dermal Irritation in rabbits-under the conditions of the study, not an irritantDermal Sensitization in the guinea pig-under conditions of the study, not a sensitizer	PassesPasses

Summary of Similarities and Differences

The device is similar in design and appearance, and has the same intended use and performance characteristics to the predicate device. The device has a different type of plasticizers from the predicate device and the plasticizer content is non phthalate. The differences between the subject devices and the predicate do not raise new questions of safety and effectiveness.

VII. PERFORMANCE DATA/TESTING

The subject device meets the requirements per ASTM D5250-06 and ASTMD6124-06 and ASTM 5151-06.

Biocompatibility Testing

The subject device is considered to be a surface device for intact skin, with limited duration (<24hours). The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
•Irritation
•Skin sensitization

The device passed all biocompatibility testing.

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VIII. CONCLUSIONS

The data in this submission indicate that both subject devices met the same performance standard as the predicate. The intended use of the predicate device and the subject devices are the same. Additionally, the subject devices successfully passed biocompatibility testing, as did the predicate device. The intended use of the subject device is the same as the predicate device and is substantially equivalent to it. The differences between the subject and predicate do not raise questions that negatively impact a finding of substantial equivalence.

The Powder Free Vinyl Patient Examination Glove (Non-Sterile) is substantially equivalent to the predicate device: Powder Free Non-Sterile Vinyl Examination Glove. Based on the nonclinical tests performed, the subject device performs as safely and as effectively as the legally marketed predicate device, Jiangsu Sunshine Plastic Products Co., Ltd. Powder Free Non-Sterile Vinyl Examination Glove cleared under K100978, Class I (21 CFR 880.6250, Product code LYZ).

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.