The 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

Nitrile Powdered patient examination glove

AI/ML Overview

The provided text is a 510(k) Premarket Notification for Nitrile Powdered Examination Gloves. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on nonclinical data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM Standard D6319-10	Meets
Physical Properties	ASTM Standard D6319-10	Meets (Elongation 500%/500%, Tensile Strength 14MPa/14MPa for before/after aging)
Freedom from Pinholes	21 CFR 800.20; ASTM D5151-06	Meets
Powder Residual	ASTM Standard D6124-06	Meets (Results generated values below 10 mg/dm² of powder)
Biocompatibility:
Primary Skin Irritation	ISO 10993-10:2010 (in rabbits)	Gloves are non-irritating
Dermal Sensitization	ISO 10993-10:2010 (in guinea pig)	Gloves do not display any potential for sensitization

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

The document does not specify the exact sample sizes for each test set that led to the "Meets" determination. It references ASTM and ISO standards for testing, which would outline the appropriate sample sizes and methodologies for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility).

The data provenance is from nonclinical testing conducted by the manufacturer (Northstar Healthcare Holdings) or a designated testing facility on their behalf, designed to demonstrate compliance with established standards. No specific country of origin or retrospective/prospective nature of the data is mentioned beyond the standards themselves.

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

This information is not applicable as the device is a patient examination glove. The "ground truth" for this type of device is established by compliance with standardized physical performance and biocompatibility tests, not by expert interpretation of images or clinical data. The standards (ASTM, ISO) themselves define the criteria for "ground truth" or acceptable performance.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, often with conflicting opinions, requiring a consensus mechanism. For the nonclinical testing of gloves, the results are quantitative measurements against predefined thresholds specified in the ASTM and ISO standards.

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 is not applicable. This device is a physical medical device (examination glove), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This is not applicable as the device is not an algorithm or an AI system. Its performance is evaluated through physical and biocompatibility testing.

7. The type of ground truth used

The ground truth for this device is based on established industry standards (ASTM and ISO), which define objective, measurable criteria for physical properties (dimensions, tensile strength, elongation, freedom from pinholes, powder residual) and biological safety (biocompatibility). The tests measure these characteristics directly against the specified thresholds.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML device that requires a training set. Its performance is assessed through direct testing against predetermined criteria.

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

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

Summary

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Abbreviated 510(k) Premarket Notification Nitrile Powdered Examination Gloves

K122998 Section 5, 510(k) Summary Page 1 of 3

510(k) SUMMARY

DATE:	February 17, 2012
OWNER:	Northstar Healthcare Holdings70 Sir John Rogerson's QuayDublin 2, Ireland

NOV 6 2012

OFFICIAL CORRESPONDENT:	Michael RiordanOperations ManagerTelephone: 00353-21-4548255Fax: 00353-21-4548294Email: michael.riordan@mckesson.ie
DEVICE NAME:	Trade Name: Textured, Blue Powdered Nitrile Examination Glove
	Common Name: Patient Examination Gloves
	Classification: Patient Examination Gloves
	Class: Class I
	Product Code: LZA

PREDICATE DEVICE(S):

Predicate510(k)	Device Name	Indication	ClearanceDate	Company
K974907	Nitrile PowderedExamination Gloves	The examination glove is a disposabledevice intended for medical and dentalpurposes that is worn on the examiner'shand to prevent contamination betweenpatient and examiner.	13 Mar 1998	Smart GloveCorp., SDN,BHD

DEVICE DESCRIPTION: Nitrile Powdered patient examination glove

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K122998

Section 5, 510(k) Summary Page 2 of 3

STATEMENT OF INTENDED USE:

The Nitrile Powdered Examination Glove is a Disposable device intended for medical and dental purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

TECHNOLOGICAL CHARACTERISTICS:

The Nitrile Powdered Examination Glove is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with nitrile using similar manufacturing processes.

Feature	Nitrile Powdered Examination GlovesK974907Predicate	Textured, Blue Nitrile Powdered Examination GlovesProposed
Intended Use	Intended for medical purposes that is worn on theexaminer's hand to prevent contamination between patientand examiner.	Same
Indications forUse Statement	The examination glove is a disposable device intended formedical and dental purposes that is worn on theexaminer's hand to prevent contamination between patientand examiner.	The examination glove is a disposable device intended formedical purposes that is worn on the examiner's hand or fingerto prevent contamination between patient and examiner.
Description	The powdered examination gloves made of nitrile. Thegloves are provided in sizes extra small, small, medium,large and extra large.	The powdered examination gloves made of nitrile. The glovesare provided in sizes small, medium, large, and extra large.
Presentation	Gloves are provided in dispenser boxes.	Same
Material	Nitrile	Same
Sterilization	Non-sterile	Same
Single Use	Yes	Same
Dimensions	Meets ASTM D3578-95	Length Small 230 mm min.Medium 230 mm min.Large 230 mm min.Extra Large 230 mm min.Width Small 80-90 mmMedium 90-100 mmLarge 100-110 mmExtra Large 110-120 mm
		Thickness Finger 0.08 mm min.Palm 0.06mm min
PhysicalProperties	Meets ASTM D3578-95	Before aging/after agingElongation 500% 500%Tensile Strength 14MPa 14MPa
Freedom fromPinholes	Meets ASTM D5151-92	Meets ASTM D5151-06
Residual Powder	Meets ASTM D6124-97	Meets ASTM D6124-06

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K122998

Page 3 of 3

Section 5, 510(k) Summary

Abbreviated 510(k) Premarket Notification Nitrile Powdered Examination Gloves

ASSESSMENT OF NONCLINICAL DATA:

Characteristic	Standard	Device Performance
Dimension	ASTM Standard D6319-10	Meets
Physical Properties	ASTM Standard D6319-10	Meets
Freedom fromPinholes	21 CFR 800.20; ASTM D5151-06	Meets
Powder Residual	ASTM Standard D6124-06	MeetsResults generatedvalues below 10mg/dm² of powder
Biocompatibility	Primary Skin Irritation inrabbits(ISO 10993-10:2010)	Gloves are non-irritating
	Dermal Sensitization in theguinea pig (ISO 10993-10:2010)	Gloves do notdisplay anypotential forsensitization

CONCLUSIONS:

The Nitrile Powdered Examination Gloves meet the requirements of established standards ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10:2010.

Based on the comparison of intended use, design, materials and performance, the Nitrile Powdered Examination Gloves are substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is oriented to follow the curve of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 6, 2012

Northstar Healthcare Holdings C/O Underwriters Laboratories, Incorporated Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062

Re: K122998

Trade/Device Name: Textured Blue Powdered Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 19, 2012 Received: October 22, 2012

Dear Mr. Devine:

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. Devine

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Digitally signed by Anthony D. Watson DN: c=US, o=U.S. Government, ou=HHHS, ou=FDA, ou=People, cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300092402 Date: 2012.11.06 14:26:52 -05/00'

Anthony D. Watson, B.S., M.S., M.B.A. 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): K122998

Device Name: Textured Blue Powdered Nitrile Examination Glove

Indications for Use: The 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.

AND/OR

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 ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for ECW
(Division Sign-Off)

(Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

510(k) Number: K122998

Page 1 of 1

Northstar Healthcare Holdings

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.