Powdered Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Device Description

MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are green in color and are powdered.

AI/ML Overview

The provided document is a 510(k) summary for "POWDERED GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". This type of device (examination gloves) is a well-established medical product, and its evaluation for regulatory clearance focuses on material properties, performance characteristics (like puncture resistance, tensile strength, and freedom from holes), and biocompatibility, rather than sophisticated signal processing or AI algorithms.

Therefore, many of the typical questions asked for AI/ML-driven medical devices, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone algorithm performance," "training set size," or "number of experts for ground truth," are not applicable to this submission. The device is a physical product, not a software algorithm.

Here's a breakdown of the requested information based on the provided text, with clarifications where questions do not apply:

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

The device is evaluated against the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The 510(k) summary explicitly states: "Gloves meet all the current ASTM D 6319-00a." and "MedtexxTM Powdered Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00a".

While the specific numerical acceptance criteria from ASTM D 6319-00a are not fully detailed in this 510(k) summary, the document indicates full compliance. ASTM D 6319-00a generally covers criteria such as:

Characteristic	Acceptance Criteria (ASTM D 6319-00a - typical values, not fully specified in this document)	Reported Device Performance (as stated in document)
Freedom from Holes	AQL 2.5 (e.g., Water Leak Test)	Meets all current specifications listed under ASTM Specification D 6319-00a
Tensile Strength	(e.g., typically ≥ 14 MPa for unbroken, ≥ 14 MPa for aged)	Meets all current specifications listed under ASTM Specification D 6319-00a
Elongation at Break	(e.g., typically ≥ 500% for unbroken, ≥ 400% for aged)	Meets all current specifications listed under ASTM Specification D 6319-00a
Puncture Resistance	(Specific requirements for examination gloves)	Meets all current specifications listed under ASTM Specification D 6319-00a
Biocompatibility	Primary Skin Irritation (non-irritant), Dermal Sensitization (non-sensitizer)	Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization.
Powder Content	Max 10 mg per glove (for powdered gloves)	Meets all current specifications listed under ASTM Specification D 6319-00a
Dimensions	Specific length, palm width, finger thickness, cuff thickness	Meets all current specifications listed under ASTM Specification D 6319-00a

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact sample sizes used for each test within the ASTM D 6319-00a standard. ASTM standards typically define sampling plans (e.g., AQL levels for visual and physical defects), but the specific number of gloves tested is not in this summary.
Data Provenance: The device manufacturer (Latexx Manufacturing Sdn. Bhd.) is located in Malaysia. The testing was performed according to ASTM D 6319-00a and 21 CFR 800.20 requirements. The details on where the tests were executed (e.g., specific lab location) are not provided. The nature of these tests (e.g., physical property measurements, biocompatibility) is prospective in the sense that they are performed on manufactured product batches to ensure compliance.

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 question is not applicable. The "ground truth" for examination gloves is established by objective physical and chemical testing (e.g., tensile strength machines, water leak tests, chemical analysis, animal biocompatibility studies), not by human expert interpretation in the same way as medical imaging or clinical diagnostic data.

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

This question is not applicable. Adjudication methods are typically used for subjective clinical assessments or interpretations where multiple observers might disagree. The tests for examination gloves are objective, laboratory-based measurements.

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

This question is not applicable. This device is an examination glove, not an AI software. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This question is not applicable. This is a physical product, not an algorithm.

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

The ground truth is established through:

Standardized physical and mechanical property testing: Per ASTM D 6319-00a (e.g., measurements for tensile strength, elongation, dimensions, leak tests).
Biocompatibility testing: Conducted using animal models for primary skin irritation (rabbit) and delayed contact sensitization (guinea pig). These are laboratory-derived ground truths based on standardized biological assay results.

8. The sample size for the training set

This question is not applicable. This device does not involve machine learning or a "training set."

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

This question is not applicable. There is no machine learning "training set" for this device.

Summary

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510(k) SUMMARY

40223647

POWDERED GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES

Submitter's Name	LATEXX MANUFACTURING SDN. BHD.
Submitter's Address	PT 5054, Kamunting Industrial Estate
	P.O. Box 9, 34600 Taiping, Perak
	Malaysia
Submitter's Phone Number	605 891 1111
Submitter 's Fax Number	605 891 1088
Name of Contact Person	Teoh, Choh Shee
Date of Preparation	July 15, 2002
Name of Device
Trade Name	MedtexxTM Powdered Green Colour Nitrile RubberExamination Glove
Common Name	Nitrile Rubber Examination Gloves
FDA SE Classification Name	Patient Examination Gloves, Powdered
FDA Classification Product Code	Nitrile - 80LZA
Legally Marketed Device to Which Equivalencyis Being Claimed	MedtexxTM Powdered Green Colour Nitrile RubberExamination Glove as described in this 510k Notification issubstantially equivalent to the current Class I patientexamination glove bearing the product code 80LZA(21CFR 880.6250). It meets all the current specificationslisted under the ASTM Specification D 6319-00a, StandardSpecification for Nitrile Examination Gloves for MedicalApplication.
Description of the Device	MedtexxTM Powdered Green Colour Nitrile RubberExamination Glove meets all the current specificationslisted under the ASTM Specification D 6319-00a, StandardSpecification for Nitrile Examination Gloves for MedicalApplication. They are made from nitrile rubber latexcompound. They are green in color and are powdered.
Intended Use of the Device	MedtexxTM Powdered Green Colour Nitrile RubberExamination Glove is intended for single use for medicalpurposes that is worn on the hand of health care andsimilar personnel to prevent contamination between thehealth care personnel and the patients.
Summary of Technological CharacteristicsCompared to the Predicate Device	There is no different technological characteristic. Glovesare made from nitrile rubber latex compound.
Brief Description of Non-clinical Tests	Testing performed per ASTM D 6319 - 00a, StandardSpecification for Nitrile Examination Gloves for MedicalApplication and 21 CFR 800.20. Gloves meet all thecurrent ASTM D 6319-00a.Primary skin irritation testing in the rabbit and delayedcontact sensitization testing in the guinea pig indicate noirritation or sensitization.
Brief Description of Clinical Tests	No new clinical tests were conducted under this 510(k).
Conclusions Drawn from the Non-clinical andClinical Tests	Non-clinical laboratory and animal based test data indicatethat the pre-powdered product meets all performance andbiocompatibility requirements.
Other Information Deemed Necessary by FDA	Not applicable.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, depicted in a flowing, abstract manner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2002

Mr. Teoh Choh Shee General Manager Latexx Manufacturing Sdn. Bhd. PT. 5054, P.O. Box 9 Kamunting Industrial Estate Taiping, Perak, MALAYSIA

Re: K022347

Trade/Device Name: Medtexx™ Green Colour Powdered Nitrile Rubber Examination Gloves Regulation Number:880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 15, 2002 Received: July 19, 2002

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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and the comments of the country

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runner

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Medtexx™ Green Colour Powdered Nitrile Rubber Examination Gloves

Image /page/4/Picture/2 description: The image shows the logo for Latexx Manufacturing SDN BHD (165989-U). The logo consists of the word "LATEXX" in a bold, sans-serif font, with a horizontal line underneath. To the right of the word is a graphic of a hand.

INDICATIONS FOR USE

Applicant

LATEXX MANUFACTURING SDN.BHD. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA

510(k) Number (if known)

K022347

Device Name

POWDERED NITRILE RUBBER EXAMINATION GLOVE, GREEN COLOUR.

Indications For Use

Concurrence of CDRH Office of Device Evaluation (ODE)

Qhin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use Per 21 CFR 801,109

Over-The-Counter

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.