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

HG PRO® Nitrile Powder Free Examination Gloves are substantially equivalent to the Class 1 patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

AI/ML Overview

The provided document describes the acceptance criteria and performance of the HG PRO® Nitrile Powder Free Examination Gloves, primarily comparing them to a predicate device (K022548) and relevant ASTM standards.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria / Standards	Reported Device Performance (Subject Device: HG PRO® Nitrile Powder Free Examination Gloves)
Material	ASTM D6319-10	Nitrile Synthetic Rubber
Color	-	Blue
Texture	-	Textured Fingers
Size	Medical Glove Guidance Manual - Labeling - Issued on January 22, 2008	Extra Small, Small, Medium, Large, Extra Large
Single Use	Medical Gloves Guidance Manual - Issued on January 22, 2008	Single use
Dimension	ASTM D6319-10	Meets ASTM D6319-10 Length: Extra Small = 220 mm minimum Small = 220 mm minimum Medium = 230 mm minimum Large = 230 mm minimum Extra Large = 230 mm minimum Palm Width: Extra Small = 60-80 mm Small = 70-90 mm Medium = 85-105 mm Large = 100-120 mm Extra Large = 110-130 mm
Thickness	ASTM D6319-10	Meets ASTM D6319-10 Finger: 0.05 mm min Palm: 0.05 mm min
Physical Properties	ASTM D6319-10	Meet ASTM D6319-10 Tensile Strength: 14 MPa min (before aging) 14 MPa min (after aging) Ultimate Elongation: 500% min (before aging) 400% min (after aging)
Watertight test (1000 ml)	ASTM D5151-06	Pass AQL 1.5
Residual Powder	ASTM D6124-06	Meet ≤ 2.0 mg/glove
Biocompatibility	Primary Skin Irritation - ISO 10993-10: 2010 Dermal Sensitization - ISO 10993-10: 2010	Pass Not a primary skin irritant under the conditions of the study Not a contact sensitizer under the conditions of the study

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 explicitly state the sample sizes used for each specific test (e.g., watertight test, physical properties). It refers to compliance with ASTM standards, which would dictate the sample sizes for those tests. The data provenance is not specified, but the manufacturer is based in Thailand (Healthy Glove Co., Ltd.). The studies appear to be prospective, laboratory-based tests conducted to meet established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of device and testing presented. The "ground truth" for examination gloves is established by meeting predefined physical, chemical, and biological standards (ASTM, ISO), not by expert consensus on clinical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is an examination glove, and its performance is evaluated against objective, measurable standards, not through adjudication by experts on subjective clinical interpretations.

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-powered diagnostic device, but a physical medical device (examination glove). Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is an examination glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is established by objective, measurable physical, chemical, and biological performance standards as defined by organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:

Dimensions: Measured against specified ranges (e.g., length, palm width).
Thickness: Measured against minimum requirements.
Physical Properties: Tensile strength and ultimate elongation measured against minimum requirements (before and after aging).
Watertightness: Tested against leakage rates (AQL 1.5).
Residual Powder: Measured against maximum limits.
Biocompatibility: Tested for primary skin irritation and dermal sensitization using established biological evaluation standards (ISO 10993-10).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

Summary

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

April 4, 2016

Healthy Glove Co., Ltd. Teoh Shee Managing Director 119 Kanchanavanich Road, Tambol Patong Hat Yai, Songkhla 90230 THIALAND

Re: K152479

Trade/Device Name: HG PRO® Nitrile Powder Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 15, 2016 Received: March 7, 2016

Dear Mr. Shee:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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" (21 CFR 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K152479

Device Name

HG PRO® Nitrile Powder Free Examination Gloves

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.

Type 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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Image /page/3/Picture/1 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left and a white hexagon on the right. Inside the pink circle are horizontal lines, and inside the hexagon are the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.

ongkhla 90230, Thailand Tel: +66 74 536815 Fax: +66 74

510(k) SUMMARY HG PRO® Nitrile Powder Free Examination Gloves

1.0 Submitter:

Applicant:	Healthy Glove Co., Ltd
	119 Kanchanavanich Road, Tambol Patong
	Hat Yai, Songkhla 90230
	Thailand
Phone Number:	+66 74 536 815
Fax Number:	+66 74 536 816
Name of Contact Person:	Teoh, Choh Shee
Preparation date:	January 15, 2016

2.0 Name of Device:

Trade/Proprietary Name(s):	HG PRO® Nitrile Powder Free Examination Gloves
Common Name:	Patient Examination Glove
Classification Name:	Patient Examination Gloves (21 CFR 880.6250 product code LZA)
Device Class:

3.0 Identification of The Legally Marketed Devices that equivalency is claimed

Device Name:	MEDTEXX™ Blue Colour Powder Free Nitrile Rubber ExaminationGlove
Manufacturer:	Latexx Manufacturing Sdn., Bhd
510(k):	K022548
MDL:	-
Regulatory Class:	I
Product Code:	LZA

4.0 Description of the Device:

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Image /page/4/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" in blue inside of a white hexagon. The text "SRITONG GROUP" is written in blue below the logo.

Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

5.0 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.

6.0 Summary of Technological Characteristics Compared to the Predicate Device:

There are no different technological characteristics of the Subject Device compared to the Predicate Device.

HG PRO® Nitrile Powder Free Examination Gloves are summarized with the following technological characteristics compared to ASTM D 6319 or equivalent standards as shown in Table 1.

Characteristics	Reference/Standards	Predicate: K022548Non-Sterile, Powder Free NitrileExamination glove	Subject Device:New 510(k) submissionNon-Sterile, Powder Free NitrileExamination glove
Manufacturer(s)		Latexx Manufacturing Sdn., Bhd.	Healthy Glove Co., Ltd
Indication for Use	Medical Gloves GuidanceManual	A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner	A patient examination glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner
Material	ASTM D6319-10	Nitrile Synthetic Rubber	Nitrile Synthetic Rubber
Color	-	Blue	Blue
Texture	-	Textured Fingers	Textured Fingers
Size	Medical Glove GuidanceManual-Labeling- Issuedon January 22, 2008	Extra SmallSmallMediumLargeExtra Large	Extra SmallSmallMediumLargeExtra Large
Single Use	Medical Gloves GuidanceManual -Issued onJanuary 22, 2008	Single use	Single use
Characteristics	AcceptanceCriteria/Standards	Predicate: K022548Non-Sterile, Powder FreeNitrile Examination glove	Subject Device:New 510(k) submissionNon-Sterile, Powder FreeNitrile Examination glove
Dimension	ASTM D6319-10	Meets ASTM D6319-10	Meets ASTM D6319-10
			Length
			Extra Small = 220 mm minimumSmall = 220 mm minimumMedium = 230 mm minimumLarge = 230 mm minimumExtra Large = 230 mmminimum
			Palm Width
			Extra Small = 60-80 mmSmall = 70-90 mmMedium = 85-105 mmLarge = 100-120 mmExtra Large = 110-130 mm

Thickness	ASTM D6319-10	Meets ASTM D6319-10	Meets ASTM D6319-10
			Finger: 0.05 mm min
			Palm: 0.05 mm min
PhysicalProperties	ASTM D6319-10	Meet ASTM D6319-10	Meet ASTM D6319-10
			Tensile Strength:
			14 MPa min (before aging)
			14 MPa min (after aging)
			Ultimate Elongation:
			500% min (before aging)
			400% min (after aging)
Watertight test(1000 ml)	ASTM D5151-06	Pass	Pass AQL 1.5
Residual Powder	ASTM D6124-06	Meet≤ 2.0 mg/glove	Meet≤ 2.0 mg/glove
Biocompatibility	Primary Skin Irritation - ISO10993-10: 2010	Pass	Pass
			Not a primary skin irritantunder the conditions of thestudy

	Dermal Sensitization - ISO10993-10: 2010	Pass	Not a contact sensitizer underthe conditions of the study

Table 1. Side-by-Side Comparison of Predicate Device with Subject Device: Indication for Use, Non-clinical Performance Data and Technological Characteristics

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Image /page/5/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles that are connected. The left circle contains horizontal lines, and the right circle contains the letters "HG" in blue. The text "SRITONG GROUP" is located below the logo.

HEALTHY GLOVE CO., LTD., LTD.
119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: +66 74 536815 Fax: +6 74 536 816

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Image /page/6/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left containing horizontal lines, and a white hexagon on the right containing the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.

7.0 Substantial Equivalent Based on Assessment of Non-clinical Performance Data:

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in the previous section (ASTM Requirements).

8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:

No Clinical testing was required to determine substantial equivalence of this device.

9.0 Conclusion:

Based on the comparison of the intended use, technological characteristics and non-clinical performance test data, the Subject Device HG PRO® Nitrile Powder Free Examination Glove is substantially equivalent to the Predicate Device K022548

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.