A patient examination glove is a 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 Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Patient Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from pin-holes	ASTM D 5151-11 & ASTM D 6319-10	Meets
Powder Free Residue	ASTM D 6124-11 & ASTM D 6319-10	Meets
Biocompatibility: Dermal Sensitization	Dermal Sensitization (as per ISO 10993-10:2010)	Not a contact skin sensitizer
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation Test (as per 16 CFR Part 1500)	Not a primary skin irritant
Sterility	Non-Sterile (inherent characteristic)	Non-Sterile
Single Use	Yes (inherent characteristic)	Yes

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

The provided document (K123760) does not specify the sample size used for the test set for any of the performance characteristics. It only states that the device "Meets" the standards or passes the biocompatibility tests.

The data provenance is not explicitly stated as "country of origin" for the specific test data, but the submitter is based in Malaysia. The testing refers to international and US-based standards (ASTM, ISO, CFR), implying these tests were conducted according to those guidelines, potentially by an accredited lab. The study is retrospective in the sense that the test data was collected prior to this submission, but it's not a clinical study involving patients over time.

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

This information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards, not through clinical expert review or diagnosis of medical images/conditions. The "ground truth" for this type of device is defined by the technical specifications outlined in the ASTM, ISO, and CFR standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective assessments, often by human readers (e.g., radiologists interpreting images). The performance of these gloves is assessed objectively against quantifiable standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. This document describes a physical medical device (gloves) and its conformity to technical standards.

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

This information is not applicable. This device is a physical product, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on established industry standards and regulatory criteria. These involve:

Physical Specifications: ASTM D6319-10 for dimensions and physical properties.
Freedom from Defects: ASTM D5151-11 and D6319-10 for pin-holes.
Chemical Properties: ASTM D6124-11 and D6319-10 for powder-free residue.
Biocompatibility: ISO 10993-10:2010 for dermal sensitization and 16 CFR Part 1500 for primary skin irritation.

These standards define the acceptable range or limits for each characteristic.

8. The Sample Size for the Training Set

This information is not applicable. This submission concerns a physical medical device and its conformity to standards. There is no AI or machine learning "training set" involved in its evaluation.

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

This information is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation, as described in point 7, is established by industry and regulatory bodies through the development and publication of the relevant standards.

Summary

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K123760

ASSURGUARD SDN. BHD. (Company No.888413-H)

FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information

Date: 16 January 2013

1.0 Submitter:

JAN 2 8 2013

Name:	ASSURGUARD SDN. BHD.
Address:	82F, Jalan Pulasan, 41000 Klang, Selangor Darul Ehsan, Malaysia.
Country:	Malaysia
Phone No.:	+603 3297 1020
Fax No.:	+603-3291 3594
Registration No.:	Pending (First Device)

2.0 Contact Person:

Contact:	Mr. Lim Hui Guan
E-mail:	assurguard@gmail.com
Telephone No.:	+603 3297 1020
Fax No.:	+603 3291 3594

3.0 Name of Device:

Trade Name:	Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile.
Common Name:	Patient Examination Glove
Classification Name:	Patient Examination Glove.

Identification of The Legally Marketed Device: 4.0

The Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, Class I Patient Examination gloves, 80LZA, meets all of the requirements of ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application.

Predicate Device: K121464, Blue Powder Free Nitrile Patient Exam Glove

5.0 Description of Device:

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.

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ASSURGUARD SDN. BHD. (Company No.888413-H)

6.0 Intended Use of the Device:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Summary of The Technological Characteristics of The Device: 7.0

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile, possesses the following technological characteristic (as compared to ASTM or equivalent standards):

Characteristic	Standards	Device Performance
Dimensions	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from pin-holes	ASTM D 5151-11ASTM D 6319-10	MeetsMeets
Powder Free Residue	ASTM D 6124-11ASTM D 6319-10	MeetsMeets
Biocompatibility	Dermal Sensitization(as per ISO 10993-10:2010)	Not a contact skin sensitizer
	Primary SkinIrritation Test(as per 16 CFR Part1500)	Not a primary skin irritant

8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data that support a determination of substantial equivalence are described above.

Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

Clinical data are not needed for market cleared examination gloves.

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ASSURGUARD SDN. BHD. (Company No.888413-H)

10.0 Conclusion

It can be concluded that the Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile is safe and effective for use and will perform according to the glove performance standards referenced in Section 7.0 above.

11.0 Substantial Equivalence Discussion

There is no different between the proposed device and the predicate with respect to indications for use and technological characteristics.

The gloves are identical to predicate device with 510(k) K121464.

The substantial equivalence comparison is presented in Table below:-

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ASSURGUARD SDN. BHD. (Company No.888413-H

Section 11.0 Substantial Equivalence Compariso

Characteristics	Predicate DeviceK121464, Blue Powder Free Nitrile Patient Exam Glove	Proposed DevicePowder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile.
Product Code	80 LZA	Same
FDA Device Class	Class I	Same
Intended Use	Intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.	Same
Indications for Use	A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.	Same
Construction	Ambidextrous, Powder Free, Blue, per ASTM D6319 specification.	Ambidextrous, Powder Free, Blue and White, per ASTM D6319 specification.
Materials	Nitrile Butadiene Rubber	Same
PerformanceI. SterilityII. Freedom from holesIII. Dimension	Non-SterileMeets ASTM D6319Meets ASTM D6319	SameSameSame

Page 4 of 5 (Rev 1)

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ASSURGUARD SDN. BHD. (Company No.888413-H

V.
PhysicalProperties	Meets ASTM D6319	Same
V. Powder FreeResidue	Meets ASTM D6319	Same
Single Use	Yes	Same
Biocompatibility Test	Passesi. Primary Skin Irritation Testii. Dermal Sensitization Test	Same
Packaging	Packed in Dispenser Boxes	Same

Page 5 of 5 (Rev 1)

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 28, 2013

Mr. Lim Hui Guan Managing Director Assurguard Sdn. Bhd. 82F, Jalan Pulasan Selangor Darul Ehsan Malaysia 41000

Re: K123760

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored). Non-Sterile

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 1, 2012 Received: December 7, 2012

Dear Mr. Guan:

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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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,

Anthong Lo mia

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): K \23 760

Powder Free Nitrile Patient Examination Gloves, Blue Colored and Device Name: White (Non-Colored). Non-Sterile

Indication For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Elizabeth F. Claverie 2013.01.22 18:10:26 -05'00'

K/23760

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

510(k) Number:

Page 1 of

ਮ

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.