MPXX™ Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Description

MPXX™™ Powder Free Natural Rubber Latex Examination Gloves are substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.

AI/ML Overview

The provided document is a 510(k) premarket notification for MPXX™ Powder Free Natural Rubber Latex Examination Gloves, demonstrating substantial equivalence to a predicate device (K981767). It describes the device's technical characteristics and the non-clinical tests performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally aligned with ASTM D 3578-05 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20. The reported device performance indicates that the MPXX™ gloves meet or exceed these specifications.

Characteristic/Parameter	Acceptance Criteria (from Predicate Device - ASTM D 3578-95 unless otherwise specified)	Reported Device Performance (MPXX™ Gloves)	Result
Product Code	80LYY	80LYY	Meets
Intended Use	Single use device for medical purposes, worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and patient.	Same as acceptance criteria	Meets
Glove Thickness (Palm)	≥ 0.08mm (ASTM D 3578-95)	Meets ASTM D 3578-05: ≥ 0.08mm	Meets (and updated ASTM standard)
Glove Thickness (Finger)	≥ 0.08mm (ASTM D 3578-95)	Meets ASTM D 3578-05: ≥ 0.08mm	Meets (and updated ASTM standard)
Glove Length	≥ 230mm (ASTM D 3578-95)	Meets ASTM D 3578-05: ≥ 240mm	Meets (and exceeds length requirement)
Tensile Strength	≥ 14MPa (ASTM D 3578-95)	Meets ASTM D 3578-05: ≥ 18MPa	Meets (and exceeds strength requirement)
Elongation	≥ 700% (ASTM D 3578-95)	Meets ASTM D 3578-05: ≥ 650%	Meets (Note: The predicate states ≥ 700% while the subject states ≥ 650%. Both state they meet ASTM D 3578-05 for the subject and ASTM D 3578-95 for the predicate, which implies a potential standard revision or slightly different interpretation. However, the document asserts "Substantial Equivalence").
Freedom from Holes (AQL)	AQL 1.5 (21CFR800.20, with ASTM D 3578-05 requiring AQL 2.5)	Gloves Free of Holes at quality level of AQL 1.5 (AQL 2.5 required per standard)	Meets (and exceeds standard requirement by having a tighter AQL)
Materials	Natural Rubber Latex	Natural Rubber Latex	Meets
Color	Natural Color	Natural Color	Meets
Biocompatibility	Passes: Primary Skin Irritation; Dermal Sensitization	Passes: Primary Skin Irritation; Dermal Sensitization	Meets
Powder Free	≤ 2 mg per glove	≤ 2 mg per glove	Meets
Protein Content	≤ max 50 (ug/dm²)	≤ max 50 (ug/dm²)	Meets
Sterility	Non-sterile	Non-sterile	Meets

Study Proving Acceptance Criteria is Met:

The study proving the device meets the acceptance criteria is a non-clinical testing program performed according to the requirements of ASTM D 3578-05, "Standard Specification for Rubber Examination Gloves," and 21 CFR 800.20. Additionally, biocompatibility testing was conducted.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for tensile strength, AQL, or thickness). The ASTM standards typically define sampling plans, but the specifics are not provided in this summary.
Data Provenance: The testing was performed by TOTAL GLOVE COMPANY SDN. BHD., located in Malaysia. The tests are non-clinical, laboratory-based. The data is prospective in the sense that it was generated for this specific 510(k) submission to demonstrate conformity with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the ground truth for glove performance (e.g., tensile strength, dimensions, freedom from holes, biocompatibility) is established by objective, standardized laboratory measurements against defined ASTM and CFR specifications, not by expert consensus or interpretation of visual data.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective, quantitative measurements against established standards, not on subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is an examination glove, not an AI-assisted diagnostic tool, so such a study would not be relevant. The submission states, "No new clinical tests were conducted under this 510(k)."

6. Standalone Performance Study

Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done. The non-clinical tests described are for the device (the glove) itself, without human interaction influencing the measurement of its physical and biological properties. The tests (e.g., tensile strength, elongation, thickness, freedom from holes, biocompatibility, protein content, powder level) are direct measurements of the glove's attributes.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance is based on established industry standards and regulatory requirements, specifically:

ASTM D 3578-05: Standard Specification for Rubber Examination Gloves.
21 CFR 800.20: Regulations for medical device performance.
Biocompatibility Standards: Primary skin irritation testing and delayed contact sensitization testing (which are also often guided by ISO 10993 series or similar standards, though not explicitly named in the brief summary).
USP Iodine Test: For the absence of starch.

These standards define the acceptable range or threshold for each characteristic.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (examination glove), not an artificial intelligence or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no training set for this type of device.

Summary

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K110250

OCT 1 4 2011

MPXX™ POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES

Submitter's Name	TOTAL GLOVE COMPANY SDN. BHD.
Submitter's Address	Lot 2584, Jalan Perusahaan 3,Kamunting Industrial Estate34600 Taiping, Perak,Malaysia
Submitter's Phone Number	605-8295 512
Submitter's Fax Number	605-8915 500
Name of Contact Person	Ooi Loon Seng
Date of Preparation	06 October 2011
Name of DeviceTrade Name	: MPXX™ POWDER FREE NATURAL RUBBERLATEX EXAMINATION GLOVES
Common Name	: Latex Examination Gloves
Classification Name	: Patient Examination Gloves
Legally Marketed Device to which Equivalency isBeing Claimed	MPXX™ Powder Free Natural Rubber LatexExamination Gloves as described in this 510 KNotification is substantially equivalent toK981767, Qtexx Powder-Free Latex ExaminationGloves with 50 Micrograms or Less of TotalWater Extractable Protein Per Gram which is thecurrent Class 1 Patient Examination Glovebearing the product code 80LYY ( 21 CFR880.6250 ). It meets all the current specificationslisted under the ASTM Specification D 3578-05,Standard Specification for Rubber ExaminationGloves.

Description of the Device	MPXX™™ Powder Free Natural Rubber LatexExamination Gloves are substantially equivalentto the Class 1 patient examination glove bearingthe product code 80LYY ( 21 CFR 880.6250 ). Itmeets all the current specifications listed underthe ASTM Specification D-3578-05, StandardSpecification for Rubber Examination Gloves.They are made from natural rubber latex. Theyare natural white in color and are powder free.
Intended Use of the Device	MPXX™™ Powder Free Natural Rubber LatexExamination Gloves are intended for single usefor medical purposes that is worn on the hand ofhealthcare and similar personnel to preventcontamination between healthcare personnel andthe patient.
Summary of Technological CharacteristicCompared to the Predicate Device	There is no different technological characteristic.Gloves are made from natural rubber latexcompound and the initial products are lowpowdered natural rubber latex gloves. Thesegloves are using the existing technology, i.e.multiple washing and rinsing processes.
Brief Description of Non-Clinical Tests	Testing were performed per ASTM D 3578-05,Standard Specification for Rubber ExaminationGloves and 21 CFR 800.20. Gloves meet all thecurrent ASTM D 3578-05 requirements.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in theguinea pig indicate no irritation or sensitization.Final product has been tested negative for thepresence of starch using the USP iodine test.
Brief description of Clinical Tests	No new clinical tests were conducted under this510(k).
Conclusions Drawn from the Non-Clinical andClinical Tests	Non-Clinical laboratory and animal based testdata indicate that the powder free product meetsall performance and biocompatibilityrequirements.
Other Information Deemed Necessary by FDA	Not Applicable.

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Characteristicsand Parameters	Subject DeviceMPXX™ Powder FreeNatural Rubber LatexExamination Gloves	Predicate DeviceQtexx Powder-FreeLatex ExaminationGloves with 50Micrograms or Less ofTotal WaterExtractable Protein PerGram (K981767)	SubstantialEquivalence(SE)
Product Code	80LYY	80LYY
Intended Use	MPXX™ Powder FreeNatural Rubber LatexExamination Gloves is asingle use deviceintended for medicalpurposes that is worn onthe hand of healthcareand similar personnel toprevent contaminationbetween healthcarepersonnel and thepatient.	Qtexx Powder-FreeLatex ExaminationGloves with 50Micrograms or Less ofTotal Water ExtractableProtein Per Gram is asingle use deviceintended for medicalpurposes that is worn onthe hand of health careand similar personnel toprevent contaminationbetween the health carepersonnel and thepatient.	Yes,SubstantialEquivalence
Glove Thicknessand Length	Meets ASTM D 3578-05:-Palm Thickness of ≥0.08mm-Finger Thickness ≥0.08mm-Length ≥ 240mm	Meets ASTM D 3578-95:-Palm Thickness of ≥0.08mm-Finger Thickness ≥0.08mm-Length ≥ 230mm	Yes,SubstantialEquivalence
Tensile Strength	Meets ASTM D 3578-05:- Tensile Strength ≥18MPa (≥ 18MPa perStandard )- Elongation ≥ 650%	Meets ASTM D 3578-95:- Tensile Strength ≥14MPa (≥ 14MPa perStandard )- Elongation ≥ 700%	Yes,SubstantialEquivalence
Freedom fromHoles	Meets Requirements per21CFR800.20:Gloves Free of Holes atquality level of AQL 1.5(AQL 2.5 required perstandard)	Meets Requirements per21CFR800.20:Gloves Free of Holes atquality level of AQL 1.5(AQL 2.5 required perstandard)	Yes, Identical
Materials	Natural Rubber Latex	Natural Rubber Latex	Yes,SubstantialEquivalence
Color	Natural Color	Natural Color	Yes, Identical
Biocompatibility	Passes:- Primary Skin Irritation- Dermal Sensitization	Passes:- Primary Skin Irritation- Dermal Sensitization	Yes, Identical
Powder Free	Meets ApplicableDefinition for PowderFree; ≤ 2 mg per glove	Meets ApplicableDefinition for PowderFree: ≤ 2 mg perglove	Yes, Identical
Protein Content	Meets ApplicableDefinition for ProteinContent; ≤ max 50(ug/dm²)	Meets ApplicableDefinition for ProteinContent; ≤ max 50(ug/dm²)	Yes, Identical
Sterility	Not applicable: Non-sterile	Not applicable: Non-sterile	Yes, Identical

Substantial Equivalence Comparison Table

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MPXX™ Powder Free Natural Rubber Latex Examination Gloves

100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -

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Image /page/4/Picture/1 description: The image shows a circular seal or emblem. The seal features a stylized graphic of three curved lines, resembling a bird in flight or a flowing design. Encircling the graphic is text, which appears to be part of the seal's official designation, possibly related to a government agency or organization.

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

OCT 1 4 2011

Total Gloves. SDN BHD C/O Ms. Ooi Loon Seng Regulatory Affairs Manager Lot 2584, Jalan Perusahaan 3. Kamunting Industrial Estate Taipang City, Perak Province MALAYSIA 34600

Re: K110250

Trade/Device Name: MPXX" Powder-Free Natural Rubber Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LY Y Dated: September 12, 2011 Received: September 16, 2011

Dear Ms. Seng:

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 - Ms. Seng

Enclosure

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Antimony D. Matson

Anthony B. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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MPXX IM Powder Free Natural Rubber Latex Examination Gloves

Attachment 2

INDICATIONS FOR USE K110250

Applicant TOTAL GLOVE COMPANY SDN. BHD. Lot 2584, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia.

510(k) Number K110250 -(if known)

Device Name

MPXX™ Powder Free Natural Rubber Latex Examination Gloves

Indications For Use

Eghert R.C.C. Laimins W.M.S

(Division Sign-Off) Concurrence of CDRH Office of Device Evaluation (ODE ) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110250

Prescription Use Per 21 CFR 801.109

OR 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.