A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

The SBG Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound. Blue in color, powder free and non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "SBG Blue Nitrile Powder Free Medical Examination Glove." This document outlines the device's characteristics, its comparison to a predicate device, and the results of various non-clinical tests to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria	Proposed Device Performance (SBG Blue Nitrile Powder Free Medical Examination Glove)	Predicate Device Performance (EMG Blue Nitrile Medical Examination Glove Powder Free)	Comparison
Product Code	LZA	LZA	LZA	Same
Intended Use	Disposable device for medical purposes, worn on hands/fingers to prevent contamination, for over-the-counter use.	Matches acceptance criteria description.	Matches acceptance criteria description.	Same
Material Use	Not made from Natural Rubber Latex	Nitrile latex compound	Nitrile latex compound	Same
Color	Blue	Blue	Blue	Same
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Same
Dimensions: Overall Length (mm)	220 mm (sizes XS-S), 230 mm (sizes M-XL)	Size Medium: 234 mm	Size Medium: 245 mm	Same
Dimensions: Width (± 10 mm)	Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm	Size Medium: 97 mm	Size Medium: 94 mm	Same
Dimensions: Thickness at Finger (mm)	All Sizes = 0.05 mm	0.11 mm	0.17 mm	Same
Dimensions: Thickness at Palm (mm)	All Sizes = 0.05 mm	0.10 mm	0.10 mm	Same
Physical Properties
Tensile Strength (MPa)	14 min.	37	34	Same
Ultimate Elongation (%)	500 min.	590	600	Same
After Aging (ASTM 6319-10 (D573) - 70°C ± 2 °C for 166 hrs ± 2 hrs.): Tensile Strength (MPa)	14 min.	38	30	Same
After Aging: Ultimate Elongation (%)	500 min.	533	560	Same
Freedom from Holes (D 5151)	AQL 2.5 Inspection Level G-1, Accept at 5 failures, Reject at 6 failures	Meets ASTM D5151-06	Meets ASTM D5151-06	Same
Residual Powder (D 6124)	≤ 2.0 mg/pc	0.18 mg	0.20 mg	Same
Biocompatibility
Primary Skin Irritation Test (ISO 10993-10:2010 (E))	(Implicitly: not a primary skin irritant)	Under the conditions of the study, not a primary skin irritant.	Under the conditions of the study, not a primary skin irritant.	Same
Dermal Sensitization Assay (ISO 10993-10:2010 (E))	(Implicitly: not a contact sensitizer)	Under conditions of the study, not a contact sensitizer.	Under conditions of the study, not a contact sensitizer.	Same
Safety Assessment (Systemic Toxicity)	(Implicitly: low potential health risk)	The results from the safety assessment demonstrated the device presents a low potential health risk.	/ (Not explicitly stated for predicate in table, but implied by "Same" in other biocompatibility tests)	Different (Table shows a "/" for predicate implying direct data not provided in this row)

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

The document does not explicitly state the specific sample sizes used for each test (e.g., freedom from holes, physical properties, biocompatibility) or their data provenance (country of origin, retrospective/prospective). However, for tests like "Freedom from Holes (D 5151)," it mentions an "AQL 2.5 Inspection Level G-1," which implies a statistically defined sampling plan as per ASTM D5151-06. The standard for biocompatibility tests (ISO 10993-10) also specifies testing guidelines.

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

This information is not provided in the document. The document describes non-clinical tests (physical properties, biocompatibility) of a medical examination glove, which typically rely on standardized testing protocols rather than expert consensus on a test set (as would be the case for AI/imaging devices).

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, particularly in AI models for medical imaging. The tests described here are objective, quantitative measurements of material properties and biological responses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic or interpretive tools to assess how human readers' performance changes with AI assistance. The device in question is a physical glove, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone study as defined for AI algorithms was not done. The device is a physical product, and its performance is evaluated based on its material properties and safety characteristics, not an algorithm's output.

7. The Type of Ground Truth Used:

The "ground truth" for the tests described are objective physical and chemical measurements and biological responses as defined by specific ASTM and ISO standards. For example:

Freedom from Holes: Defined by the ASTM D5151-06 standard and its specified AQL (Acceptance Quality Limit).
Tensile Strength & Ultimate Elongation: Measured according to material testing standards.
Residual Powder: Measured according to ASTM D6124.
Biocompatibility (Primary Skin Irritation, Dermal Sensitization): Determined by standardized animal or in-vitro tests following ISO 10993-10:2010 (E) protocols. The outcomes (e.g., "not a primary skin irritant") serve as the ground truth based on the established biological criteria of these tests.

8. The Sample Size for the Training Set:

This concept is not applicable to this device. A "training set" is used for machine learning algorithms. This device is a physical glove, not an AI model, and therefore does not have a training set.

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

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

October 10, 2018

Showa Best Glove, Inc Jeffrey Richardson Director of Operations 579 Edison Street Menlo, California 30731-6335

Re: K180467

Trade/Device Name: SBG Blue Nitrile Powder Free Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 4, 2018 Received: September 6, 2018

Dear Jeffrey Richardson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray lii III -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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Indications for Use

510(k) Number (if known) K180467

Device Name

SBG Blue Nitrile Powder Free Medical Examination Glove

Indications for Use (Describe)

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K180467

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1. SUBMITTER

Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: 706-862-6740 Fax: 706-862-2660 Date: October 1, 2018

2. OFFICIAL CORRESPONDENCE/CONTACT PERSON

Jeffrey Richardson Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: 706-862-6740 Fax: 706-862-2660 Email: cmitchell@showagroup.com

3. 510(K) PREPARER

Carol Mitchell, Executive Assistant to President/COO Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: 706-862-6724 Fax: 706-862-2660 Email: cmitchell@showagroup.com

Margaret Savage, RA/QA Supervisor Showa Best Glove, Inc. 931 Second Ave. SE Fayette, AL 35555 Tel: 205-932-3202 134 Fax: 205-932-5904 Email: tsavage@showagroup.com

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4. DEVICE

Brand Name of Device: SBG Blue Nitrile Powder Free Medical Examination Glove Common or Usual Name: Patient Examination Glove Classification Name: Non-powdered Patient Examination Glove Regulation: 21 CFR 880.6250 Device Classification: Class: I Product Code: LZA

5. PREDICATE DEVICE

Trade Name: EMG Blue Nitrile Medical Examination Glove Powder Free Common Name: Patient Examination Glove 510(k) Number: K141590 Manufacturer: ECO MEDI GLOVE SDN. BHD

6. INDICATIONS FOR USE

A powder free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

7. DEVICE DESCRIPTION

The SBG Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound. Blue in color, powder free and non-sterile. The proposed device was tested according to the following standards listed in the table below:

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SUMMARY OF COMPARING TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE 8.

There is no difference in the technology characteristics when compared to the predicate device. Both the proposed and predicate devices are made from a nitrile latex compound, Blue in color, powder free and non-sterile.

		Proposed Device	Predicate Device	Comparison
Characteristics	AcceptanceCriteria	SBG Blue NitrilePowder Free MedicalExamination Glove510(k) NumberK180467	EMG Blue NitrileMedical ExaminationGlove Powder Free510(k) NumberK141590
Product Code	LZA	LZA	LZA	Same
Intended Use	A patient examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hands orfingers to preventcontaminationbetween patient andexaminer. The deviceis for over-the-counteruse.	A powder free patientexamination gloves is adisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use.	A powder free patientexamination gloves is adisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use.	Same
Material Use	Not made fromNatural RubberLatex	Nitrile latex compound	Nitrile latex compound	Same
Color	Blue	Blue	Blue	Same
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Same
Dimensions	Overall Length (mm)220 mm = (sizes XS-S)230 mm = (sizes M-XL)Width (± 10 mm)Size S = 80 mmSize M = 95 mmSize L = 110 mmSize XL = 120 mmThickness at Finger(mm)All Sizes = 0.05 mmThickness at PalmAll Sizes = 0.05 mm	Size MediumPalm Width: 97 mmLength: 234 mmFinger Thickness: 0.11 mmPalm Thickness: 0.10 mm	Size MediumPalm Width: 94 mmLength: 245 mmFinger Thickness: 0.17 mmPalm Thickness: 0.10 mm	Same
Characteristics	AcceptanceCriteria	Proposed Device	Predicate Device	Comparison
		SBG Blue NitrileMedical PowderFreeExaminationGloveK180467	EMG Blue NitrileMedicalExamination GlovePowder Free510(k) NumberK141590
Physical Properties	Tensile Strength(MPa) = 14 min.	Tensile Strength (MPa)37	Tensile Strength (MPa)34	Same
	Ultimate Elongation(%) = 500 min.	Ultimate Elongation(%)590	Ultimate Elongation (%)600	Same
	After Aging ASTM 6319-10 (D573)(70°C ± 2 °C for 166 hrs ± 2 hrs.)
		Tensile Strength(MPa) = 14 min	Tensile Strength (MPa)38	Tensile Strength (MPa)30
	Ultimate Elongation(%) = 500 min.	Ultimate Elongation(%)533	Ultimate Elongation (%)560	Same
Freedom from Holes(D 5151)	AQL 2.5 InspectionLevel G-1Accept at 5 failuresReject at 6 failures	AQL 2.5 InspectionMeets ASTM D5151-06	AQL 2.5 InspectionMeets ASTM D5151-06	Same
Residual Powder(D 6124)	≤ 2.0 mg/pc	0.18 mg	0.20 mg	Same
Biocompatibility test -Primary Skin IrritationTest(ISO 10993-10:2010 (E)		Under the conditionsof the study, not aprimary skin irritant.	Under the conditions ofthe study, not a primaryskin irritant.	Same
Biocompatibility testDermal SensitizationAssay (ISO 10993-10:2010 (E)		Under conditions ofthe study, not acontact sensitizer	Under conditions of thestudy, not a contactsensitizer	Same
Safety Assessment(Systemic Toxicity)		The results from thesafety assessmentdemonstrated thedevice presents a lowpotential health risk	/	Different

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9. CONCLUSIONS

The conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.

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.