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 D3578:05-2010

AI/ML Overview

The provided text describes the acceptance criteria and the performance of an A1 Brand Powder Free Patient Examination Glove. This document is a 510(k) summary for a medical device (patient examination glove), which is often supported by non-clinical performance data rather than extensive clinical studies as seen with AI/software as a medical device (SaMD). Therefore, many of the requested points, particularly those related to AI algorithm performance, ground truth establishment, expert adjudication, and multi-reader multi-case studies, are not applicable to this type of device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

CHARACTERISTICS	STANDARDS	SPECIFICATION (Acceptance Criteria)	DEVICE PERFORMANCE/ACTUAL SPECIFICATION (Reported Performance)
Dimensions	ASTM D3578:05-2010	Thickness Palm: min 0.08mm Finger: min 0.08mm	Meet. Palm Thickness: 0.09 mm Finger Thickness: 0.11 mm
		Length (by size) S: min 220 M: min 220 L: min 230	Length (by size) S: 240 mm M: 240 mm L: 240 mm
Physical Properties	ASTM D3578:05-2010 ASTM D412:06 ASTM D573:04-2010	Tensile Strength (MPa) Before aging: Min 18 MPa After aging: Min 14 MPa	Meet.Tensile Strength (MPa) Before aging: 22.91 MPa After Aging: 20.98 MPa
		Elongation at Break (%) Before aging: Min 650mm After aging: Min 500mm	Elongation at Break (%) Before aging: 850 mm After aging: 820 mm
Freedom from pin-holes	ASTM D5151:06-2011	AQL 1.5	Meet
Powder Free Residue	ASTM D6124:06-2011	Below 2mg/glove	Meet
Protein Content	ASTM D5712:10-2010	Below 50ug/dm²	Meet
Biocompatibility	Animal Irritation Test (ISO 10993-10:2010)	Under the conditions tested, the subject glove was not an irritant.	Under the conditions tested, the subject glove was not an irritant.
	Dermal Sensitization (ISO 10993-10:2010)	Under the condition tested, the subject glove was not a sensitizer.	Under the condition tested, the subject glove was not a sensitizer.

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

The document does not specify the exact sample sizes (e.g., number of gloves tested for each characteristic) used for the non-clinical tests. It refers to compliance with ASTM and ISO standards, which typically include sampling plans. The data provenance is Malaysia, where A1 Glove Sdn. Bhd. is located. These are non-clinical (laboratory/bench) tests, not retrospective or prospective human subject data.

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 not an AI/SaMD and does not use "ground truth" derived from expert consensus on medical images or diagnoses. The "ground truth" for glove performance is defined by the objective measurements and chemical analyses specified by the ASTM and ISO standards.

4. Adjudication method for the test set

Not applicable. There is no adjudication method described as this is not a study involving human interpretation or subjective assessment of medical data. The tests are objective measurements against defined 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 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.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established international standards and objective laboratory measurements (e.g., precise measurements of thickness, tensile strength, chemical residue, and biological reactivity according to ASTM and ISO protocols). There is no pathology, outcomes data, or expert consensus used in the typical sense for medical imaging or diagnostic algorithms.

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 that requires a training set.

Summary

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

September 6, 2016

A1 Glove Sdn. Bhd. Mr. John Phan Lot 3726, Kawasan Perindustrian Nilai, Mukim Setul Nilai. Negeri Sembilan 71900 MALAYSIA

Re: K153744

Trade/Device Name: A1 Brand Powder Free Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LYY Dated: July 13, 2016 Received: July 13, 2016

Dear: John Phan

This letter corrects our substantially equivalent letter of July 13, 2016.

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 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

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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 contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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.

Susan Runno DDS, MA

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

510(k) Number (if known) K 153744

Device Name

A 1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contain 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Indications for Use (Describe)

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.

pe 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)

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510(k) Summary

A1 GLOVE SDN. BHD.

Date: 8th July 2016

510k number: K 153744

1.01 Submitter:

Name	: A1 Glove Sdn. Bhd.
Address	: Lot 3726, Kawasan Perindustrian Nilai,Mukim Setul, Daerah Seremban, Malaysia
Country	: Malaysia
Phone No.	: +60 6012028

1.02 Contact Person:

Contact	: Mr. John Phan
E-mail	: john_phan@hotmail.com
Telephone No.	: +6019-3544-880
Fax No.	: +60-6 799 6066

1.03 Name of Device:

Trade Name	: A1 Glove Powder Free Latex Patient Examination Gloves with
	Protein Content Labeling Claim (Contain 50 Micrograms
	per dm² of glove or Less of Water Extractable Protein)
Common Name	: Patient Examination Gloves
Classification Name	: Patient Examination Glove
Product Code	: LYY

1.04 Identification of The Legally Marketed Device:

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contain 50 Micrograms per dm of Glove or Less of Water Extractable Protein), LYY, meets all of the requirements of ASTM D-3578 Standard Specification of Latex Examination Gloves for Medical Application which equivalent to legally marketed device of K112612.

Predicate Device: K112612, Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein)

1.05 Description of Device

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1.06 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.

1.07 Summary of the Technological Characteristics of the Device

Powder Free Latex Examination Gloves possesses the following technological characteristic (as compared to ASTM or equivalent standard):

CHARACTERISTICS	STANDARDS	SPECIFICATION	DEVICE PERFORMANCE/ACTUAL SPECIFICATION
Dimensions	ASTM D3578:05-2010	ThicknessPalm : min 0.08mmFinger: min 0.08mm	Meet.Palm Thickness: 0.09 mmFinger Thickness: 0.11 mm
		Length (by size)S : min 220M : min 220L : min 230	Length (by size)S : 240 mmM : 240 mmL : 240 mm
Physical Properties	ASTM D3578:05-2010ASTM D412:06ASTM D573:04-2010	Tensile Strength (MPa)Before aging : Min 18 MPaAfter aging : Min 14 MPa	MeetTensile Strength (MPa)Before aging : 22.91 MPaAfter Aging : 20.98 MPa
		Elongation at Break (%)Before aging : Min 650mmAfter aging: Min 500mm	Elongation at Break (%)Before aging : 850 mmAfter aging : 820 mm
Freedom from pin-holes	ASTM D5151:06-2011	AQL 1.5	Meet
Powder Free Residue	ASTM D6124:06-2011	Below 2mg/glove	Meet
Protein Content	ASTM D5712:10-2010	Below 50ug/dm²	Meet
Biocompatibility	Animal Irritation Test(ISO 10993-10:2010)	Under the conditionstested, the subject glovewas not an irritant.	Under the conditions tested, thesubject glove was not anirritant.
	Dermal Sensitization(ISO 10993-10:2010)	Under the condition tested,the subject glove was not asensitizer.	Under the condition tested, thesubject glove was not asensitizer.

1.08 Substantial Equivalent based on Assessment of Non-Clinical Performance Data The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as shown on the table above.

1.09 Substantial Equivalent based on Assessment of Clinical Performance Data Clinical data for the subject glove is not needed.

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1.10 Substantial Equivalence Comparison
Characteristic &Parameters	Predicate Device	Proposed Device	Specification	SubstantialEquivalence
	K112612, Powder Free LatexPatient Examination Glovewith Protein Content LabelingClaim (Contains 50Micrograms per dm² of gloveor Less of Water ExtractableProtein)	A1 Glove Powder Free LatexPatient Examination Gloveswith Protein Content LabelingClaim (Contain 50 Microgramsper dm² of glove or Less ofWater Extractable Protein)		SE
Product Code	LYY	LYY		SE
FDA Device Class	Class I	Class I		SE
Intended Use	A patient examination gloves isa disposable device intendedfor medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner.	A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner.		SE
Material	Natural Rubber Latex	Natural Rubber Latex		SE
Dimensions	Meets ASTM D3578	Meets ASTM D3578:05-2010	ThicknessPalm : min 0.08mmFinger : min 0.08mmLength (by size)S : min 220M : min 220L : min 230	SE
Physical Properties	Meets ASTM D3578	Meets ASTM D3578:05-2010	Tensile Strength (MPa)Before aging : Min 18 MPaAfter aging : Min 14 MPaElongation at Break (%)Before aging : Min 650mmAfter aging: Min 500mm	SE
Freedom from Pin Holes -ASTM D5151	Meets ASTM D5151	Meets ASTM D5151:06:2011	AQL 1.5	SE
Protein Content-ASTM D5712	Meets ASTM D5712	Meets ASTM D5712:10-2010	Below 50ug/dm²	SE
Skin IrritationISO 10993-10:2002	Under the condition tested, thesubject glove was not anirritant.	Under the condition tested, thesubject glove was not anirritant.	Under the condition tested,the subject glove was not anirritant.	SE
Dermal sensitizationISO 10993-10:2002	Under the condition tested, thesubject glove was not asensitizer.	Under the condition tested, thesubject glove was not asensitizer.	Under the condition tested,the subject glove was not asensitizer.	SE

1.10 Substantial Equivalence Comparison

Table 1.10. Substantial Equivalence Comparison

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1.11 Conclusion

The conclusion drawn from the non-clinical testing demonstrates that the subject glove is as safe, as effective, and performs as well as the legally marketed predicate device, K112612.

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.