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 Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Powder Free Latex Patient Examination Gloves), not an AI/ML medical device. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted relevant to the provided text:

Acceptance Criteria and Device Performance

1. Table of acceptance criteria and the reported device performance:

Characteristic	Standards	Acceptance Criteria (Implied by "Meets Standards")	Device Performance
Dimensions	ASTM D 3578-10	Meets ASTM D 3578-10	Meets
Physical Properties	ASTM D 3578-10	Meets ASTM D 3578-10	Meets
Freedom from pin-holes	ASTM D 5151-11, ASTM D 3578-10	Meets ASTM D 5151-11, Meets ASTM D 3578-10	Meets ( दोनों के लिए)
Powder Free Residue	ASTM D 6124-11, ASTM D 3578-10	Meets ASTM D 6124-11, Meets ASTM D 3578-10	Meets ( दोनों के लिए)
Protein Content	ASTM D 5712-10, ASTM D 3578-10	Meets ASTM D 5712-10, Meets ASTM D 3578-10	Meets ( दोनों के लिए)
Biocompatibility: Dermal Sensitization	(as per ISO 10993-10:2010)	Not a contact skin sensitizer	Not a contact skin sensitizer
Biocompatibility: Primary Skin Irritation Test	(as per ISO 10993-10:2010)	Not a primary skin irritant	Not a primary skin irritant

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for testing each characteristic. The "data provenance" is not explicitly stated in terms of country of origin for the test data, but the submitter is based in Malaysia. The testing would be prospective in nature, as it relates to testing the manufactured product before marketing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical product, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" is defined by the objective measurement adhering to industry standards (ASTM, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Testing involves objective measurements against established physical and chemical standards, not subjective 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 for a physical medical glove, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a physical medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is established by the international and national standards referenced (ASTM D 3578-10, ASTM D 5151-11, ASTM D 6124-11, ASTM D 5712-10, ISO 10993-10:2010). The device is deemed to meet these objective, pre-defined standards.

8. The sample size for the training set:
Not applicable. This is a physical product, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a physical product, not an AI/ML algorithm.

Summary

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K123757

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

FEB 0 1 2013

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

Date: 01 December 2012

1.0 Submitter:

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 Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein), Natural Color Common Name: Patient Examination Glove Classification Name: Patient Examination Glove.

Identification of The Legally Marketed Device: 4.0

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein), 80L Y Y, meets all of the requirements of ASTM D3578 Standard Specification for Latex Examination Gloves for Medical Application.

Predicate Device: K112988, Powder Free Latex Patient Exam Glove, Smooth and Textured natural Color (Off White) with Protein Labeling Claim (50 ug/dm² or Less of Water Soluble Protein)

5.0 Description of Device:

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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 Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards):

Characteristic	Standards	Device Performance
Dimensions	ASTM D 3578-10	Meets
Physical Properties	ASTM D 3578-10	Meets
Freedom from pin-holes	ASTM D 5151-11ASTM D 3578-10	MeetsMeets
Powder Free Residue	ASTM D 6124-11ASTM D 3578-10	MeetsMeets
Protein Content	ASTM D 5712-10ASTM D 3578-10	MeetsMeets
Biocompatibility	Dermal Sensitization(as per ISO 10993-10:2010)	Not a contact skin sensitizer
	Primary SkinIrritation Test(as per ISO 10993-10:2010)	Not a primary skin irritant

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

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 Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm2 of Glove or Less of Water Extractable Protein) is safe and effective for use and will perform according to the glove performance standards referenced in Section 7.0 above.

Substantial Equivalence Discussion 11.0

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) K112988.

The substantial equivalence comparison is presented in Table below:-

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

. .

Page 4 of 5

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II. Freedom from holes	Meets ASTM D3578	Same
II. Dimension	Meets ASTM D3578	Same
V. Physical Properties	Meets ASTM D3578	Same
V. Powder Free Residue	Meets ASTM D3578	Same
VI. Protein Content	Meets ASTM D3578	Same
Single Use	Yes	Same
Biocompatibility Test	Passesi. Primary Skin Irritation Testii. Dermal Sensitization Test	Same
Packaging	Packed in Dispenser Boxes	Same
Labeling Claim	With Extractable Protein Content Labeling Claim	Same

. . .

1000

. . . .

Page 5 of 5

. .

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it.

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

February 1, 2013

Mr. Lim H. Guan Managing Director Assurguard Sdn. Bhd 82F, Jalan Pulasan Klang Selangor, Malaysia 41000

Re: K123757

Trade/Device Name: Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein), Natural Color

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY 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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Page 2 - Mr. Guan

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 (OS) 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/CDRHQffices/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,

hor.

Keith
Harshfield.

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 123 757

Powder Free Latex Patient Examination Gloves, with Protein Content Device Name: Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein), Natural Color.

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)

Sheila A. Murphey

N: <= US, o=U.S. Government, ou-=FDA. ou=People. on=Sheila A. Murphev 342.19200300.100.1.1=1300369048 2013.01.28 13:59:22 -05.00

Dialtally sloned by Shella A Murpher

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

510(k) Number:

Page 1 of

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.