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

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device, specifically the "SBG Black Nitrile Powder Free Medical Examination Glove" (K180468).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison table (page 5) between the proposed device (SBG Black Nitrile Powder Free Medical Examination Glove, K180468) and a predicate device (EMG Black Nitrile Medical Examination Glove Powder Free, K141579). This table serves as the primary source for acceptance criteria and reported performance for the proposed device, demonstrating equivalence to the predicate.

Characteristics	Acceptance Criteria (from Predicate/Standards)	Proposed Device Performance (SBG Black Nitrile Powder Free Medical Examination Glove K180468)	Comparison Status
Product Code	LZA	LZA	Same
Intended Use	A 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. The device is for over-the-counter use.	A powder free 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 device is for over-the-counter use.	Same
Material Use	Not made from Natural Rubber Latex	Nitrile latex compound	Same
Color	Black	Black	Same
Sterility	Non-Sterile	Non-Sterile	Same
Dimensions
Overall Length (mm)	220 mm = (sizes XS-S), 230 mm = (sizes M-XL) (Standard)	272 mm Minimum All Sizes	Similar (Proposed device exceeds minimums)
Width (± 10 mm)	Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm (Standard)	Size S = 70-90 mm, Size M = 85-105 mm, Size L = 100-120 mm, Size XL = 110-130 mm	Similar (Proposed device falls within ranges)
Thickness at Finger (mm)	All Sizes = 0.05 mm (Standard)	0.16 mm Minimum All Sizes	Similar (Proposed device exceeds minimum)
Thickness at Palm (mm)	All Sizes = 0.05 mm (Standard)	0.14 mm Minimum All Sizes	Similar (Proposed device exceeds minimum)
Physical Properties Before Aging (ASTM 6319-10 (D 412))
Tensile Strength (MPa)	≥ 14 min.	≥ 14	Same
Ultimate Elongation (%)	≥ 500 min.	500 min.	Same
Physical Properties After Aging (ASTM 6319-10 (D573) - 70°C ± 2 °C for 166 hrs ± 2 hrs.)
Tensile Strength (MPa)	≥ 14 min.	≥ 14	Same
Ultimate Elongation (%)	≥ 500 min.	500 min.	Similar
Freedom from Holes (D 5151)	AQL 2.5 Inspection Level G-1, Accept at 5 failures, Reject at 6 failures	AQL 2.5 Inspection Level G-1, Pass	Same
Residual Powder (D 6124)	≤ 2.0 mg/pc	Contains less than 2.0 mg	Same
Biocompatibility Test - Primary Skin Irritation Test (ISO 10993-10:2010 (E))	(Implicit: not a primary skin irritant)	Under the conditions of the study, not a primary skin irritant.	Same
Biocompatibility Test - Dermal Sensitization Assay (ISO 10993-10:2010 (E))	(Implicit: not a contact sensitizer)	Under conditions of the study, not a contact sensitizer	Same
Safety Assessment (Systemic Toxicity)	(Implicit: acceptable health risk)	The results from the safety assessment demonstrated the device presents a low potential health risk	Different (Predicate not shown, but implies satisfactory result)

Note on "Acceptance Criteria": For characteristics where a numerical value is given (e.g., Tensile Strength), that is the explicit acceptance criteria. For qualitative characteristics (e.g., Material Use, Color), the "Acceptance Criteria" column reflects the shared characteristic with the predicate or a general industry expectation. For biocompatibility and safety assessments, the criteria are implied to be "not a primary skin irritant," "not a contact sensitizer," and "low potential health risk," respectively.

2. Sample size used for the test set and the data provenance

The document refers to various ASTM and ISO standards for testing (e.g., D 412, D 573, D 5151, D 6124, ISO 10993-10:2010 (E)). These standards often specify sample sizes for their respective tests. However, the exact sample sizes used for each test performed on the proposed device are not explicitly stated in this summary.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is assumed these were prospective tests performed by the manufacturer or contracted labs to verify the device's conformance to standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to the evaluation of this device. The device is a "Patient Examination Glove," which is a Class I device and its performance is assessed through physical, chemical, and biological testing against established standards, not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human interpretation or subjective assessments. The tests for a medical examination glove are objective measurements against predefined 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

This information is not applicable. The device is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This information is not applicable. As mentioned above, the device is a physical examination glove, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established national and international standards for medical examination gloves (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10). These standards define the acceptable physical properties (tensile strength, elongation, dimensions), freedom from holes, residual powder levels, and biocompatibility.

8. The sample size for the training set

This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical product and does not involve machine learning.

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

This information is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 10, 2018

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

Re: K180468

Trade/Device Name: SBG Black 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) K180468

Device Name

SBG Black 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.

Type of Use (Select one or both, as applicable)

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

K180468

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 Black Nitrile Powder Free Medical Examination Glove Common or Usual Name: Patient Examination Glove Classification Name: Non-powdered Patient Examination Glove Requlation: 21 CFR 880.6250 Device Classification: Class: I Product Code: LZA

5. PREDICATE DEVICE

Trade Name: EMG Black Nitrile Medical Examination Glove Powder Free Common Name: Patient Examination Glove 510(k) Number: K141579 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 Black Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound, black 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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8. SUMMARY OF COMPARING TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

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, black in color, powder free and non-sterile.

		Proposed Device	Predicate Device	Comparison
Characteristics	AcceptanceCriteria	SBG Black NitrilePowder Free MedicalExamination GloveK180468	EMG Black NitrileMedical ExaminationGlove Powder FreeK141579
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 thatis worn 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 from NaturalRubber Latex	Nitrile latex compound	Nitrile latex compound	Same
Color	Black	Black	Black	Same
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Same
Dimensions	Overall Length (mm)220 mm = (sizes XS-S)230 mm = (sizes M-XL)	Overall Length (mm)272 mm MinimumAll Sizes	Overall Length (mm)300 mm MinimumAll Sizes	Similar
	Width (± 10 mm)Size S = 80 mmSize M = 95 mmSize L = 110 mmSize XL = 120 mm	Width (± 10 mm)Size S = 70-90 mmSize M = 85-105 mmSize L = 100-120 mmSize XL = 110-130 mm	Width (± 10 mm)Size S = 81-90 mmSize M = 90-100 mmSize L = 100-110 mmSize XL = 110-120 mm
	Thickness at Finger (mm)All Sizes = 0.05 mm	Thickness at Finger (mm)0.16 mm MinimumAll Sizes	Thickness at Finger (mm)0.17 mm MinimumAll Sizes
	Thickness at PalmAll Sizes = 0.05 mm	Thickness at Palm (mm)0.14 mm MinimumAll Sizes	Thickness at Palm (mm)0.14 mm MinimumAll Sizes
		Proposed Device	Predicate Device	Comparison
Characteristics	AcceptanceCriteria	SBG Black NitrileMedical PowderFree ExaminationGlove K180468	EMG Black NitrileMedical ExaminationGlove Powder FreeK141579
Before Aging ASTM 6319-10 (D 412)
Physical Properties	Tensile Strength(MPa) = 14 min.	Tensile Strength (MPa)≥ 14	Tensile Strength (MPa)≥ 14	Same
	Ultimate Elongation(%) = 500 min.	Ultimate Elongation (%)500 min.	Ultimate Elongation (%)500 min.	Same
	After Aging ASTM 6319-10 (D573)(70°C ± 2 °C for 166 hrs ± 2 hrs.)
	Tensile Strength(MPa) = 14 min.	Tensile Strength (MPa)≥ 14	Tensile Strength (MPa)≥ 14	Same
	Ultimate Elongation(%) = 500 min.	Ultimate Elongation (%)500 min.	Ultimate Elongation (%)500 min.	Similar
Freedom from Holes(D 5151)	AQL 2.5 InspectionLevel G-1Accept at 5 failuresReject at 6 failures	AQL 2.5 InspectionLevel G-1Pass	AQL 2.5 InspectionLevel G-1Pass	Same
Residual Powder(D 6124)	≤ 2.0 mg/pc	Contains less than2.0 mg	Contains less than 2.0 mg	Same
Biocompatibility test -Primary Skin IrritationTest(ISO 10993-10:2010 (E))		Under the conditions ofthe study, not a primaryskin irritant.	Under the conditions of thestudy, not a primary skinirritant.	Same
Biocompatibility testDermal SensitizationAssay (ISO 10993-10:2010 (E))		Under conditions of thestudy, not a contactsensitizer	Under conditions of thestudy, not a contactsensitizer	Same
Safety Assessment(Systemic Toxicity)		The results from thesafety assessmentdemonstrated the devicepresents a low potentialhealth 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.