SBG Black Nitrile Powder Free Medical Examination Glove

K180468 · Showa Best Glove, Inc. · LZA · Oct 10, 2018 · General Hospital

Device Facts

• Record ID: K180468
• Device Name: SBG Black Nitrile Powder Free Medical Examination Glove
• Applicant: Showa Best Glove, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Oct 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Single-use, non-sterile, black nitrile latex compound examination glove; worn on hands/fingers by clinicians or patients to provide barrier protection against contamination; disposable; no electronic or mechanical components; provides physical barrier to reduce cross-contamination risk.

Clinical Evidence

Bench testing only. Device evaluated for physical properties (tensile strength, ultimate elongation) per ASTM D412 and D573, freedom from holes per ASTM D5151, and residual powder per ASTM D6124. Biocompatibility testing performed per ISO 10993-10 (primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Nitrile latex compound. Form factor: Disposable, black, non-sterile glove. Standards: ASTM D412, ASTM D573, ASTM D6124, ASTM D5151, ISO 10993-10. No electronic components or software.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hands or fingers to prevent contamination between patient and examiner. Suitable for over-the-counter use.

Regulatory Classification

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.

Predicate Devices

• EMG Black Nitrile Medical Examination Glove Powder Free (K141579)

Submission Summary (Full Text)

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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<br>Criteria | SBG Black Nitrile<br>Powder Free Medical<br>Examination Glove<br>K180468 | EMG Black Nitrile<br>Medical Examination<br>Glove Powder Free<br>K141579 | |
| Product Code | LZA | LZA | LZA | Same |
| Intended Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hands or<br>fingers to prevent<br>contamination<br>between patient and<br>examiner. The device<br>is for over-the-counter<br>use. | A powder free patient<br>examination gloves is a<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over-the-<br>counter use. | A powder free patient<br>examination gloves is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over-the-<br>counter use. | Same |
| Material Use | Not made from Natural<br>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)<br>220 mm = (sizes XS-S)<br>230 mm = (sizes M-XL) | Overall Length (mm)<br>272 mm Minimum<br>All Sizes | Overall Length (mm)<br>300 mm Minimum<br>All Sizes | Similar |
| | Width (± 10 mm)<br>Size S = 80 mm<br>Size M = 95 mm<br>Size L = 110 mm<br>Size XL = 120 mm | Width (± 10 mm)<br>Size S = 70-90 mm<br>Size M = 85-105 mm<br>Size L = 100-120 mm<br>Size XL = 110-130 mm | Width (± 10 mm)<br>Size S = 81-90 mm<br>Size M = 90-100 mm<br>Size L = 100-110 mm<br>Size XL = 110-120 mm | |
| | Thickness at Finger (mm)<br>All Sizes = 0.05 mm | Thickness at Finger (mm)<br>0.16 mm Minimum<br>All Sizes | Thickness at Finger (mm)<br>0.17 mm Minimum<br>All Sizes | |
| | Thickness at Palm<br>All Sizes = 0.05 mm | Thickness at Palm (mm)<br>0.14 mm Minimum<br>All Sizes | Thickness at Palm (mm)<br>0.14 mm Minimum<br>All Sizes | |
| | | Proposed Device | Predicate Device | Comparison |
| Characteristics | Acceptance<br>Criteria | SBG Black Nitrile<br>Medical Powder<br>Free Examination<br>Glove K180468 | EMG Black Nitrile<br>Medical Examination<br>Glove Powder Free<br>K141579 | |
| Before Aging ASTM 6319-10 (D 412) | | | | |
| Physical Properties | Tensile Strength<br>(MPa) = 14 min. | Tensile Strength (MPa)<br>≥ 14 | Tensile Strength (MPa)<br>≥ 14 | Same |
| | Ultimate Elongation<br>(%) = 500 min. | Ultimate Elongation (%)<br>500 min. | Ultimate Elongation (%)<br>500 min. | Same |
| | After Aging ASTM 6319-10 (D573)<br>(70°C ± 2 °C for 166 hrs ± 2 hrs.) | | | |
| | Tensile Strength<br>(MPa) = 14 min. | Tensile Strength (MPa)<br>≥ 14 | Tensile Strength (MPa)<br>≥ 14 | Same |
| | Ultimate Elongation<br>(%) = 500 min. | Ultimate Elongation (%)<br>500 min. | Ultimate Elongation (%)<br>500 min. | Similar |
| Freedom from Holes<br>(D 5151) | AQL 2.5 Inspection<br>Level G-1<br>Accept at 5 failures<br>Reject at 6 failures | AQL 2.5 Inspection<br>Level G-1<br>Pass | AQL 2.5 Inspection<br>Level G-1<br>Pass | Same |
| Residual Powder<br>(D 6124) | ≤ 2.0 mg/pc | Contains less than<br>2.0 mg | Contains less than 2.0 mg | Same |
| Biocompatibility test -<br>Primary Skin Irritation<br>Test<br>(ISO 10993-10:2010 (E)) | | Under the conditions of<br>the study, not a primary<br>skin irritant. | Under the conditions of the<br>study, not a primary skin<br>irritant. | Same |
| Biocompatibility test<br>Dermal Sensitization<br>Assay (ISO 10993-<br>10:2010 (E)) | | Under conditions of the<br>study, not a contact<br>sensitizer | Under conditions of the<br>study, not a contact<br>sensitizer | Same |
| Safety Assessment<br>(Systemic Toxicity) | | The results from the<br>safety assessment<br>demonstrated the device<br>presents a low potential<br>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.