SBG Black Nitrile Powder Free Medical Examination Glove

• K Number: K180468
• Device Name: SBG Black Nitrile Powder Free Medical Examination Glove
• Manufacturer: Showa Best Glove, Inc.
• Date Cleared: 2018-10-10 ( 231 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

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.

Predicate Devices

K141579

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and safety of a medical examination glove, with no mention of AI or ML technology.

Therapeutic

No
A therapeutic device is used to treat or alleviate a disease or condition. This device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," which is a preventative and protective function, not a therapeutic one.

Diagnostic

No

Explanation: The device is a medical examination glove, which is used for protection and contamination prevention, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of nitrile latex compound, not software. The description clearly outlines its material and physical characteristics.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
• Device Description and Intended Use: The provided information clearly states the device is a "powder free patient examination glove" intended to be worn on the hands or fingers to prevent contamination. This is a barrier device used on the body, not for testing specimens from the body.

The description and intended use align with a Class I or Class II medical device used for protection and hygiene, not for diagnostic testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

LZA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or fingers

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed device was tested according to the following standards listed in the table below:

1. Before Aging ASTM 6319-10 (D 412) - Physical Properties
   • Tensile Strength (MPa) = 14 min.
   • Ultimate Elongation (%) = 500 min.
2. After Aging ASTM 6319-10 (D573) (70°C ± 2 °C for 166 hrs ± 2 hrs.)
   • Tensile Strength (MPa) = 14 min.
   • Ultimate Elongation (%) = 500 min.
3. Freedom from Holes (D 5151) - AQL 2.5 Inspection Level G-1, Accept at 5 failures, Reject at 6 failures
4. Residual Powder (D 6124) - ≤ 2.0 mg/pc
5. Biocompatibility test - Primary Skin Irritation Test (ISO 10993-10:2010 (E)) - Under the conditions of the study, not a primary skin irritant.
6. Biocompatibility test Dermal Sensitization Assay (ISO 10993-10:2010 (E)) - Under conditions of the study, not a contact sensitizer.
7. Safety Assessment (Systemic Toxicity) - The results from the safety assessment demonstrated the device presents a low potential health risk.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141579

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] Date: October 1, 2018

2. OFFICIAL CORRESPONDENCE/CONTACT PERSON

Jeffrey Richardson Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: [phone] Fax: [phone] Email: [e-mail]

3. 510(K) PREPARER

Carol Mitchell, Executive Assistant to President/COO Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: [phone] Fax: [phone] Email: [e-mail]

Margaret Savage, RA/QA Supervisor Showa Best Glove, Inc. 931 Second Ave. SE Fayette, AL 35555 Tel: [phone] Fax: [phone] Email: [e-mail]

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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	Acceptance
Criteria	SBG Black Nitrile
Powder Free Medical
Examination Glove
K180468	EMG Black Nitrile
Medical Examination
Glove Powder Free
K141579
Product Code	LZA	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 gloves 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.	A powder free patient
examination gloves 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	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 Minimum
All Sizes	Overall Length (mm)
300 mm Minimum
All Sizes	Similar
	Width (± 10 mm)
Size S = 80 mm
Size M = 95 mm
Size L = 110 mm
Size XL = 120 mm	Width (± 10 mm)
Size S = 70-90 mm
Size M = 85-105 mm
Size L = 100-120 mm
Size XL = 110-130 mm	Width (± 10 mm)
Size S = 81-90 mm
Size M = 90-100 mm
Size L = 100-110 mm
Size XL = 110-120 mm
	Thickness at Finger (mm)
All Sizes = 0.05 mm	Thickness at Finger (mm)
0.16 mm Minimum
All Sizes	Thickness at Finger (mm)
0.17 mm Minimum
All Sizes
	Thickness at Palm
All Sizes = 0.05 mm	Thickness at Palm (mm)
0.14 mm Minimum
All Sizes	Thickness at Palm (mm)
0.14 mm Minimum
All Sizes
		Proposed Device	Predicate Device	Comparison
Characteristics	Acceptance
Criteria	SBG Black Nitrile
Medical Powder
Free Examination
Glove K180468	EMG Black Nitrile
Medical Examination
Glove Powder Free
K141579
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 Inspection
Level G-1
Accept at 5 failures
Reject at 6 failures	AQL 2.5 Inspection
Level G-1
Pass	AQL 2.5 Inspection
Level G-1
Pass	Same
Residual Powder
(D 6124)	≤ 2.0 mg/pc	Contains less than
2.0 mg	Contains less than 2.0 mg	Same
Biocompatibility test -
Primary Skin Irritation
Test
(ISO 10993-10:2010 (E))		Under the conditions of
the study, 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))		Under conditions of the
study, not a contact
sensitizer	Under conditions of the
study, not a contact
sensitizer	Same
Safety Assessment
(Systemic Toxicity)		The results from the
safety assessment
demonstrated the device
presents a low potential
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.