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

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.

AI/ML Overview

Based on the provided document, the device in question is Powder Free Nitrile Examination Gloves, Blue (colored). This document is a 510(k) Summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, many of the requested elements for an AI device (like human reader improvement with AI assistance, standalone performance, training set details, expert qualifications for ground truth) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria and performance data for the physical and biological characteristics of the gloves as presented in the "Summary of the Technological Characteristic" section.

Here's the breakdown:

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

Characteristic	Acceptance Criteria (Predicate / Subject Device)	Reported Device Performance (Subject Device)
Dimension
Length (size: XSmall)	Meet 220mm min	Meet 220mm min
Length (size: Small)	Meet 220mm min	Meet 220mm min
Length (size: Medium)	Meet 230mm min	Meet 230mm min
Length (size: Large)	Meet 230mm min	Meet 230mm min
Length (size: XLarge)	Meet 230mm min	Meet 230mm min
Thickness (palm)	Meet 0.05mm min	Meet 0.05mm min
Thickness (finger)	Meet 0.05mm min	Meet 0.05mm min
Width (size: XSmall)	Meet 70 ± 10 mm	Meet 70 ± 10 mm
Width (size: Small)	Meet 80 ± 10 mm	Meet 80 ± 10 mm
Width (size: Medium)	Meet 95 ± 10 mm	Meet 95 ± 10 mm
Width (size: Large)	Meet 110 ± 10 mm (Subject); 111 ± 10 mm (Predicate)	Meet 110 ± 10 mm
Width (size: XLarge)	Meet 120 ± 10 mm	Meet 120 ± 10 mm
Physical Properties
(Before Ageing) Tensile Strength	Meet 14MPa min.	Meet 14MPa min.
(Before Ageing) Elongation	Meet 500% min	Meet 500% min
(After Aging) Tensile Strength	Meets 14MPa min	Meets 14MPa min
(After Aging) Elongation	Meet 400% min.	Meet 400% min.
Water Leak Test (Before Aging)	Meet AQL 1.5	Meet AQL 1.5
Water Leak Test (After Aging)	Meet AQL 2.5	Meet AQL 2.5
Residual Powder Content	Meet 2mg/glove max.	Meet 2mg/glove max.
Biocompatibility Test
Primary Skin Irritation Test	Passes; No irritant response	Passes; No irritant response
Skin Sensitization Test	Passes; No skin sensitization effect	Passes; No skin sensitization effect

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

The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, tensile strength, or water leaks). It simply states that the subject device "Meet[s]" or "Passes" the criteria. The provenance of the data is not explicitly stated beyond being presented in a submission from Careglove Global Sdn Bhd, Malaysia, implying the testing was conducted to support their device. It's standard for these types of tests to be prospective, laboratory-based evaluations.

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

Not applicable. This device is a physical product (examination gloves), not an AI-powered diagnostic tool requiring expert interpretation for "ground truth". The performance criteria are physical and chemical measurements or biological response assessments, not based on expert consensus.

4. Adjudication method for the test set:

Not applicable for the same reasons as #3. Quality control of physical properties does not typically involve expert 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 is not an AI device.

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

Not applicable. This is not an AI device. The "standalone performance" is the inherent physical and chemical properties of the glove itself.

7. The type of ground truth used:

The "ground truth" for the physical and chemical properties of the gloves is established by standardized laboratory testing methods (e.g., likely conforming to ASTM standards like D6310, as mentioned in the document). For biocompatibility, the ground truth is established by the biological response observed in appropriate in vivo or in vitro models as per standard biocompatibility testing protocols.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

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

September 26, 2017

Careglove Global Sdn Bhd Lim Shyan Managing Director Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban, 70450 My

Re: K172015

Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue (colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: Julv 3, 2017 Received: July 3, 2017

Dear Lim Shyan:

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 (DICE) 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 (DICE) 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.

Sincerelv.

Tara A. Ryan -S

for Tina Kiang, Ph.D. Acting 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

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

510(k) Number (if known)

K172015

Device Name

POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/0 description: The image shows the logo for "CARE GLOVE". The word "CARE" is written in large, bold, blue letters. Below "CARE" is the word "GLOVE" in a light green color with a blue circle in the middle of the word with a hand in the center. Below the word "GLOVE" is the text "CAREPLUS-DESCARPACK" in blue.

AREGLOVE GLOBAL

Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com

K172015 510(K) SUMMARY

CAREGLOVE GLOBAL SDN BHD Applicant:

Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. (60) 6 6782377 Fax No. (60) 6 6785377

Contact Person:Lim Kwee Shyan

31st August, 2017 Summary Preparation Date:

Device Information

Trade Name:	POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
Common Name:	POWDER FREE NITRILE EXAMINATION GLOVES
Classification Name:	Patient Examination Gloves
Regulatory Class:
Product Code:	LZA
Regulation:	21 CFR 880.6250

Predicate Device

Device Name:	CAREPLUS POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
Product Code:	LZA
Classification Name:	Patient Examination Gloves
510K Number:	K142862
Regulatory Class:	I

Device Description

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.

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Image /page/4/Picture/0 description: The image contains a logo with the words "CARE GLOVE" stacked on top of each other. The word "CARE" is in blue, and the word "GLOVE" is in light green. There is a blue circle with a light green hand in the middle of the word "GLOVE". Below the words "CARE GLOVE" is the word "CAREPLUS-DESCARPACK" in blue.

CAREGLOVE GLOBAL SDI

Summary of the Technological Characteristic

The Powder Free Nitrile Examination Gloves – Blue are summarized with the following technological characteristic compare to ASTM D6310 or equivalent standards.

Characteristic	Subject Device	Predicate Device	ComparisonAnalysis
Product Name	Powder Free NitrileExamination Gloves, Blue(Colored)	Careplus Powder Free NitrileExamination Glove, Blue(Colored)	Different
510(k) Reference	K172015	K142862	N/A
Product Code	LZA	LZA	Same
Regulatory Class	I	I	Same
Intended Use	Intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner	Intended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner	Same
Design	Powder Free, Non-Sterile,Ambidextrous, Beaded Cuff	Powder Free, Non-Sterile,Ambidextrous, Beaded Cuff	Same
Indications forUse	A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand to preventcontamination betweenpatient and examiner	A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handto prevent contaminationbetween patient and examiner	Same
Construction	Ambidextrous, PolymerCoated or Chlorinated,Powder Free Nitrile	Ambidextrous, PolymerCoated or Chlorinated, PowderFree Nitrile	Same
Color Description	Blue	Blue	Same
Material	Nitrile	Nitrile	Same
Single Use	Yes	Yes	Same
Packaging	Packed in Dispenser Boxes	Packed in Dispenser Boxes	Same

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Image /page/5/Picture/0 description: The image is a logo for a company called "CARE GLOVE." The word "CARE" is written in large, bold, blue letters on top. Below it, the word "GLOVE" is written in a lighter green color. There is a blue circle with a light green hand in the middle of the word "GLOVE." Underneath the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in smaller, blue letters.

CAREGLOVE GLOBAL SDN BHD

Dimension
Length (size: XSmall), mmLength (size: Small), mmLength (size: Medium), mmLength (size: Large), mmLength (size: XLarge), mm	Meet 220mm minMeet 220mm minMeet 230mm minMeet 230mm minMeet 230mm min	Meet 230mm minMeet 220mm minMeet 230mm minMeet 230mm minMeet 230mm min	Same
Thickness (palm), mmThickness (finger), mm	Meet 0.05mm minMeet 0.05mm min	Meet 0.05mm minMeet 0.05mm min
Width (size: XSmall), mmWidth (size: Small), mmWidth (size: Medium), mmWidth (size: Large), mmWidth (size: XLarge), mm	Meet 70 ± 10 mmMeet 80 ± 10 mmMeet 95 ± 10 mmMeet 110 ± 10 mmMeet 120 ± 10 mm	Meet 70 ± 10 mmMeet 80 ± 10 mmMeet 95 ± 10 mmMeet 111 ± 10 mmMeet 120 ± 10 mm
Physical Properties
(Before Ageing)i) Tensile Strength (MPa)ii) Ultimate Elongation (%)	Meet 14MPa min.Meet 500% min	Meet 14MPa min.Meet 500% min	Same
(After Aging)i) Tensile Strength (MPa)ii) Ultimate Elongation (%)	Meets 14MPa minMeet 400% min.	Meets 14MPa minMeet 400% min.
Water Leak Test,1000 mlBefore Aging, AQLAfter Aging, AQL	Meet AQL 1.5Meet AQL 2.5	Meet AQL 1.5Meet AQL 2.5	Same
Residual Powder ContentResidual Powder Content,mg/glove	Meet 2mg/glove max.	Meet 2mg/glove max	Same

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Image /page/6/Picture/0 description: The image shows a logo for a company called "CARE GLOVE". The word "CARE" is in blue, and the word "GLOVE" is in light green. There is a blue circle with a light green hand in the middle of the word "GLOVE". The words "CAREPLUS-DESCARPACK" are in blue at the bottom of the logo.

CAREGLOVE GLOBAL SDN BHD

Biocompatibility Test
i) Primary Skin Irritation Test	Passesi) Primary Skin Irritation Test.Conclusion: Under the conditions of this study the test material did not cause an irritant response	Passesi)Primary Skin Irritation Test.Conclusion: Under the conditions of this study the test material did not cause an irritant response.	Same
ii)Skin Sensitization Test	ii)Dermal Sensitization Test.Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect	ii)Dermal Sensitization Test.Conclusion: Under the conditions of this study, the test material did not produce a skin sensitization effect

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Image /page/7/Picture/0 description: The image shows the logo for "CARE GLOVE". The word "CARE" is in large, bold, blue letters on top. Below it, the word "GLOVE" is in a light green color. The "O" in "GLOVE" is replaced by a blue circle with a light green handprint inside. Underneath the word "GLOVE" is the text "CAREPLUS-DESCARPACK" in small, bold, blue letters.

CAREGLOVE GLOBAL SI

Summary of Clinical Testing

Not applicable

Substantial Equivalence Conclusions.

The subject device is a safe, as effective, and performs as well as or better than the legally marketed predicate device, K142862 (Careplus Powder Free Nitrile Examination Gloves, Blue (Colored)).

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.