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

Sterile, powder free, examination gloves made of nitrile. The gloves are provided in sizes small, medium, and large. Sterile gloves are provided in dispenser boxes.

AI/ML Overview

This looks像 a request for structured information extracted from the provided text about the K122727 device. Unfortunately, the provided text describes a Disposable Nitrile Examination Glove and not an AI/ML medical device.

Therefore, many of the requested fields, such as "Sample size used for the test set," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," and "Ground truth for the training set," are not applicable to this type of device. These fields are specifically relevant to studies involving diagnostic or AI-powered devices that produce results requiring interpretation or comparison to a ground truth established by experts.

However, I can still extract the acceptance criteria and performance for the physical device characteristics from the provided text.

Here's the information that is applicable and can be extracted:

Acceptance Criteria and Device Performance (for a Nitrile Examination Glove)

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
Freedom from Pinholes	21 CFR 800.20; ASTM D5151-06	Meets
Powder Residual	ASTM Standard D6124-06	Meets (values below 2mg of residual powder)
Biocompatibility	Primary Skin Irritation in rabbits (ISO 10993-10:2010)	Gloves are non-irritating
Biocompatibility	Dermal Sensitization in the guinea pig (ISO 10993-10:2010)	Gloves do not display any potential for sensitization

Regarding the other requested points, they are not applicable to this medical device type:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical glove's performance testing described here. Performance is measured against physical standards, not, for example, diagnostic data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by the ASTM and ISO standards themselves, not by expert consensus on specific cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against objective 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: Not applicable. This is a physical glove, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical glove.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For physical properties, the "ground truth" is defined by the objective metrics and thresholds within the cited ASTM and ISO standards. For biocompatibility, it's the observed biological reactions in animal models as per ISO 10993-10:2010.
8. The sample size for the training set: Not applicable. There is no "training set" for a physical glove.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K122727

Abbreviated 510(k) Premarket Notification Sterile Nitrile Powder Free Examination Gloves Section 5, 510(k) Summary Page 1 of 3

FEB 2 2 2013

510(k) SUMMARY 5.

OFFICIAL CORRESPONDENT:

DATE:

OWNER:

September 20, 2012

Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland

Michael Riordan Operations Manager Telephone: 00353-21-4548255 Fax: 00353-21-4548294 Email: michael.riordan@mckesson.ie

DEVICE NAME:

Trade Name:	Textured Blue Sterile Powder Free NitrileExamination Gloves
Common Name:	Patient Examination Gloves
Classification:	Patient Examination Gloves
Class:	Class I
Product Code:	LZA
Regulation Number:	880.6250

PREDICATE DEVICE(S):

Predicate510(k)	Device Name	Indication	ClearanceDate	Company
K081466	Sterile Nitrile PowderFree ExaminationGloves	The examination glove is a disposabledevice intended for medical and dentalpurposes that is worn on the examiner'shand to prevent contamination betweenpatient and examiner.	30 Jul 2008	Smart GloveCorp., SDN.BHD

DEVICE DESCRIPTION: Textured Blue Sterile Powder Free Nitrile Examination Gloves

. .

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Abbreviated 510(k) Premarket Notification Sterile Nitrile Powder Free Examination Gloves Section 5, 510(k) Summary Page 2 of 3

STATEMENT OF INTENDED USE:

The Textured Blue Sterile Powder Free Nitrile Examination Gloves 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 Textured Blue Sterile Powder Free Nitrile Examination Gloves 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	Sterile Nitrile Powder Free Examination GlovesK081466Predicate	Textured Blue Sterile Powder Free NitrileExamination GlovesProposed
Intended Use	Intended for medical purposes that is worn on the examiner's hand toprevent contamination between patient and examiner.	Same
Indications forUse Statement	The examination glove is a disposable device intended for medical anddental purposes that is worn on the examiner's hand to preventcontamination between patient and examiner.	The examination glove is a disposable deviceintended for medical purposes that is worn on theexaminer's hand or finger to preventcontamination between patient and examiner.
Description	Sterile, powder free, examination gloves made of nitrile. The gloves areprovided in sizes extra small, small, medium, large and extra large.	Sterile, powder free, examination gloves made ofnitrile. The gloves are provided in sizes small,medium, and large.
Presentation	Sterile gloves are provided in dispenser boxes.	Same
Material	Nitrile	Same
Sterilization	Sterile	Same
Single Use	Yes	Same
Dimensions	Meets ASTM D6319-00a(2005)	LengthSmall 230mm min.Medium 230mm min.Large 230mm min.WidthSmall 70-90mmMedium 85-105mmLarge 101-120mmThickness Finger 0.08mm min.Palm 0.06mm min.
PhysicalProperties	Meets ASTM D6319-00a(2005)	Before aging/after agingElongation 500% 400%Tensile Strength 14MPa 14MPa
Freedom fromPinholes	Meets ASTM D5151-06	Same
ResidualPowder	Meets ASTM D6124-06	Same

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ASSESSMENT OF NONCLINICAL DATA:

Characteristic	Standard	Device Performance
Dimension	ASTM StandardD6319-10	Meets
Physical Properties	ASTM StandardD6319-10	Meets
Freedom from Pinholes	21 CFR 800.20;ASTM D5151-06	Meets
Powder Residual	ASTM StandardD6124-06	MeetsResults generatedvalues below 2mgof residualpowder
Biocompatibility	Primary Skin Irritationin rabbits(ISO 10993-10:2010)Dermal Sensitization inthe guinea pig (ISO10993-10:2010)	Gloves are non-irritatingGloves do notdisplay anypotential forsensitization

CONCLUSIONS:

The Textured Blue Sterile Powder Free Nitrile 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 Textured Blue Sterile Powder Free Nitrile Examination Gloves are substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

February 22, 2013

Northstar Healthcare Holdings C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road NORTHBROOK IL 60062

Re: K122727

Trade/Device Name: Textured Blue Sterile Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 7, 2013 Received: February 8, 2013

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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/4/Picture/7 description: The image shows a stylized graphic with illegible text. The text appears to be handwritten and overlaid on top of a geometric design. The design includes a maze-like pattern on the left and a triangular shape on the right, both rendered in black lines.

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): K122727

Textured Blue Sterile Powder Free Nitrile Examination Gloves Device Name:

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

Elizabeî 2013.02

(Division Sign-Off) Division of Anesthesloiogy, General Hospital Infection Control, Dental Devices

510(k) Number;_

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.