The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Device Description

The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

The provided document is a 510(k) summary for "Powder Free Nitrile Examination Gloves (Orange)". This document outlines the device's characteristics and compares them to a predicate device to establish substantial equivalence, which is a regulatory pathway for medical devices. It does not describe a clinical study in the typical sense of evaluating the effectiveness or safety of a new medical treatment or diagnostic algorithm.

Instead, the document details non-clinical performance data to demonstrate that the new device (Powder Free Nitrile Examination Gloves (Orange)) meets established standards and performs similarly to a legally marketed predicate device (Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, K140418).

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

CHARACTERISTICS	STANDARDS / ACCEPTANCE CRITERIA	REPORTED DEVICE PERFORMANCE (Current Device)	Comparison to Predicate
Length	ASTM D6319 - 10(2015): Length-Min 230mm, width - min 95 ± 10 mm	Length-Min 240mm, width - min 85mm for medium glove	Same
Physical Properties	ASTM D6319 - 10(2015): Before Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 500%After Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 400%	Meets: Before Aging: Tensile Strength Min 14 MPa, Ultimate Elongation Min 500%After Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 400%	Same
Thickness - Finger / Palm	ASTM D6319 - 10(2015): Palm - Min 0.05mm, Finger - Min 0.05mm	Meets: Palm - Min 0.05mm, Finger - Min 0.05mm	Same
Powder Content	ASTM D6124 - 06(2011): ≤ 2 mg/glove	Meets: ≤ 2 mg/glove	Same
Biocompatibility (Primary Skin Irritation)	ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization	Passes: Under the conditions of the study, the subject device is non-irritating	Same
Biocompatibility (Dermal Sensitization)	ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization	Passes: Under the conditions of the study, the subject device is non-sensitizing	Same
Watertight (1000ml)	21 CFR 800.20, ASTM D5151: AQL 2.5	Passes: AQL 2.5	Same
Intended Use	A 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.	The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.	Same
Material	ASTM D6319 - 10(2015)	Nitrile	Similar
Double Extra Large Size	Medical Glove Guidance Manual - Labeling	> 120mm	N/A (listed for current device only)
Single Use	Medical Glove Guidance Manual - Labeling	Single Use	Same

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 for each specific test (e.g., how many gloves were tested for length, physical properties, or watertightness). However, the tests are performed according to recognized standards (ASTM, ISO, CFR), which typically specify appropriate sampling plans.

Data Provenance: The manufacturer is "Comfort Rubber Gloves Industries Sdn. Bhd." located in Matang, Perak, Malaysia. The testing would have been conducted by or for this manufacturer. The data is prospective in the sense that these tests are performed on the manufactured product to ensure it meets the specified 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 is not applicable to this type of device and study. The "ground truth" here is objective physical and chemical properties measured against established industry standards (ASTM, ISO, CFR). It does not involve expert interpretation or clinical judgment.

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

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The tests involve objective measurements and pass/fail criteria based on 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 a 510(k) submission for examination gloves, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI integration, or assessment of human reader improvement is relevant or performed.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests are established, objective performance standards and specifications documented in:

ASTM D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124-06 (2011) - Standard Test Method for Residual Powder on Medical Gloves
ISO 10993-10:2010 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
21 CFR 800.20 - Medical device general controls
ASTM D5151 - Standard Test Method for Detection of Pinholes in Medical Gloves by Visual Inspection of the Inflated Glove

These standards define the acceptable range or threshold for physical properties (length, tensile strength, elongation, thickness), chemical properties (powder content), biological reactions (biocompatibility), and integrity (watertightness).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. The gloves are manufactured and then tested against established standards.

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

Not applicable for the same reason as point 8. The standards themselves are developed through industry consensus, scientific research, and regulatory requirements, not through a "training set" for an algorithm.

Summary

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

September 20, 2017

Comfort Rubber Gloves Industries Sdn. Bhd. Chan Men OA & OMS Manager Lot 821, Jalan Matang Matang, 34750 MY

Re: K171541

Trade/Device Name: Powder Free Nitrile Examination Gloves (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: August 29, 2017 Received: September 1, 2017

Dear Chan Men:

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

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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 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 (DICE) 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 (DICE) 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.

Sincerelv.

Tara A. Ryan -S

for 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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Attachment 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171541

Device Name

Powder Free Nitrile Examination Gloves (Orange)

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)

1.0 Submitter :

Name	: Comfort Rubber Gloves Industries Sdn. Bhd.
Address	: Lot 821, Jalan Matang,34750 Matang, Perak, Malaysia.Malaysia.
Phone No.	: 605-847 2777
Fax No.	: 605-847 9108
Contact Person	: Chan Yew Men (Mr.)

Date of Preparation : September 8, 2017

2.0 Name of the Device

Powder Free Nitrile Examination Gloves (Orange)

Common Name :	Patient Examination Gloves
Regulation Name :	Patient Examination Gloves (21 CFR 880.6250 productcode LZA)
Device Class :	Class I
510(K) Number :	K171541

3.0 Identification of The Legally Marketed Devices That equivalency is claimed:

Predicate

Device Name : Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile

Company : WRP Rubber Products Sdn. Bhd.

510(K) No. : K140418

4.0 Description of the Device:

5.0 Intended Use of the Device

The Powder Free Nitrile Examination Gloves (Oranqe) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

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Summary of the Technological Characteristics of the Device: 6.0

The Powder Free Nitrile Examination Gloves (Orange) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1 and Figure 1 on Location of thickness and length measurement.

Table 1

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
		Predicate	Current
Manufacturer(s)		WRPRubberProductsSdn Bhd	Comfort RubberGlovesIndustries Sdn.Bhd	N/A
510(k) number		K140418	K171541	N/A
Length	ASTM D6319 -10(2015)	Length-Min 230mmwidth - min 95 ± 10mm	Length-Min240mmwidth - min 85mm for mediumglove	Same
Physical Properties	ASTM D6319 -10(2015)	MeetsBefore AgingTensile Strengthmin 14 MPaUltimateElongationMin 500%After AgingTensile Strengthmin 14 MPaUltimateElongationMin 400%	MeetsBefore AgingTensile StrengthMin 14 MPaUltimateElongationMin 500%After AgingTensile Strengthmin 14 MPaUltimateElongationMin 400%	Same
Thickness - Finger- Palm	ASTM D6319 -10(2015)	MeetsPalm - Min0.05mmFinger - Min0.05mm	MeetsPalm - Min0.05mmFinger - Min0.05mm	Same
Powder Content	ASTM D6124 -06(2011)(≤ 2 mg/glove)	Meets≤ 2 mg/glove	Meets≤ 2 mg/glove	Same
Biocompatibility	Primary SkinIrritationISO 10993-10:2010Biologicalevaluation ofmedical devices --Part 10: Tests forirritation and skin	Under theconditions of thestudy, not anirritant.	PassesUnder theconditions of thestudy, thesubject device isnon-irritating	Same
	sensitization
CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE		substantiallyequivalent topredicate
		Predicate	Current
	DermalSensitizationISO 10993-10:2010Biologicalevaluationofmedical devices --Part 10: Tests forirritation and skinsensitization	Under theconditions of thestudy, not asensitizer.	PassesUnder theconditions of thestudy, thesubject device isnon-sensitizing	Same
Watertight (1000ml)	21 CFR 800.20ASTM D5151	PassesAQL 2.5	PassesAQL 2.5	Same
Intended Use	-	A patientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner.	The PowderFree NitrileExaminationGloves (Orange)is a disposabledevice intendedfor medicalpurpose that isworn on theexaminer's handor finger topreventcontaminationbetweenexaminer andpatient.	Same
Material	ASTM D6319 -10(2015)	Nitrile	Nitrile	Similiar
Color	-	Blue	Orange	-
Size	Medical GloveGuidance Manual -Labeling	Extra SmallSmallMediumLargeExtra Large	Extra Small -75mm±5mmSmall -85mm±5mmMedium -95mm±5mmLarge -105mm±5mmExtra Large-115mm±5mmDouble ExtraLarge> 120mmLength-Min240mm	Same
Single Use	Medical GloveGuidance Manual -Labeling	Single Use	Single Use	Same

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7.0 Non-Clinical Performance Data Conclusion:

The subject device and the predicate non-clinical testing results demonstrate that the devices are similar or the same for the following non-clinical testing endpoints: physical properties (same specifications for thickness and length), powder content, biocompatibility, and water tight test.

8.0 Clinical Performance Data Conclusion:

9.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the Powder Free Nitrile Examination Gloves (Orange) device is substantially equivalent to the predicate device K140418.

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.