Disposable Nitrile Examination Gloves

K210897 · Shandong DS Safety Technology Co., Ltd. · LZA · Aug 24, 2021 · General Hospital

Device Facts

• Record ID: K210897
• Device Name: Disposable Nitrile Examination Gloves
• Applicant: Shandong DS Safety Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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.

Device Story

Disposable nitrile examination glove; ambidextrous; non-sterile; blue; finger-textured. Worn by clinicians or patients to prevent cross-contamination during medical examinations. Device acts as a physical barrier. No electronic components or software. Used in clinical or home settings. Benefits include protection against contamination during patient-examiner interaction.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified via ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (freedom from holes), and ASTM D6124-06 (residual powder). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity/pyrogenicity).

Technological Characteristics

Material: Nitrile (Acrylonitrile-butadiene copolymer). Form: Ambidextrous, non-sterile, powder-free, blue, finger-textured. Dimensions: Length 220-230mm, thickness ≥0.05mm. Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-1, 2, 5, 10, 11, 12.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free nitrile glove worn on the examiner's hand or finger to prevent contamination between patient and examiner in an over-the-counter setting.

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

• Blue Nitrile Examination Gloves Powder Free (K192333)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 24, 2021

Shandong DS Safety Technology Co., Ltd. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College Blvd. Ste 475 Santa Clara, California 95054

Re: K210897

Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 19, 2021 Received: July 26, 2021

Dear Rafi Wong:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K210897

Device Name

Disposable Nitrile Examination Gloves

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 hand or finger to prevent contamination between patient and examiner. The device is for over thecounter use.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------|
| <input type="checkbox"/> Research involving rCBH subjects only |
| <input checked="" type="checkbox"/> Secondary Research involving rCBH subjects only |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510K SUMMARY

Date of Summary Prepared: August 24,2021

# 510K Number: K210897

# 1. Submitter Information

## Submitter Contact:

| Address: | SHANDONG DS SAFETY TECHNOLOGY CO.,LTD. |
|----------|-----------------------------------------------------|
| | West of Yaoqian Road, Yaogezhuang Community, |
| | Economic Development Zone, Gaomi City, Weifang City |
| | Shandong 261502, China |

## Submitter Contact Person:

| Name: | Summer Feng |
|---------------|---------------------|
| Phone Number: | [phone] |
| Email: | [e-mail] |

# Designated Submission Correspondent:

| Name: | Rafi Wong |
|---------------|--------------------------|
| Phone Number: | [phone] |
| Email: | [e-mail] |

- 2. Device Name: Disposable Nitrile Examination Gloves
## 3. Regulatory Information

| Common Name: | Polymer Patient Examination Glove |
|-------------------------|-----------------------------------|
| Apparel Classification: | Class I |
| Product Code: | LZA |

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Regulation Number: 21 CFR 880.6250

### 4. Predicate Device

| 510K Number: | K192333 |
|---------------|----------------------------------------------------|
| Company name: | JR Engineering & Medical Technologies (M) SDN.BHD. |
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Cleared date: | January 24, 2020 |

#### 5. Intended 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.

#### 6. Device Description

The proposed Disposable Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, and is made of nitrile (Acrylonitrile-butadiene copolymer) and chemical additives. It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile.

# 7. Summary of Comparison and Technological Characteristics

| Characteristics | Acceptance<br>Criteria | Proposed<br>Device<br>Disposable<br>Nitrile<br>Examination<br>Gloves | Predicate Device<br>Blue Nitrile<br>Examination<br>Gloves Powder<br>Free | Comparison |
|-----------------|------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------|------------|
| 510K Number | / | K210897 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Manufacturer | / | SHANDONG<br>DS SAFETY<br>TECHNOLOGY<br>CO.,LTD. | JR Engineering &<br>Medical<br>Technologies (M)<br>SDN.BHD. | Different |

## Table I - General Comparison

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| Classification | Class I (21 CFR<br>880.6250) | Class I (21 CFR<br>880.6250) | Class I (21 CFR<br>880.6250) | Same |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended Use | A patient<br>examination glove<br>is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>examiner's hands or<br>fingers to prevent<br>contamination<br>between patient and<br>examiner. The<br>device is for over-<br>the-counter use. | A powder free<br>patient<br>examination<br>glove is a<br>disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's hand<br>or finger to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>The device is for<br>over-the-counter<br>use. | A powder free<br>patient<br>examination<br>gloves is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient<br>and examiner. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |

# 8. Non-clinical Tests Performed on the Proposed Device

The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008

## STANDARDS:

- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical . Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06/(R)2017 Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization

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- . ISO 10993-5: 2009 Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity
- AAMI / ANSI / ISO 10993-11: 2017 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
- . ISO 10993- 1: 2009/(R)2013 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process
- . ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

| | | Proposed<br>Device | Predicate Device | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristics | Acceptance<br>Criteria | Disposable Nitrile<br>Examination<br>Gloves<br>(K210897) | Blue Nitrile<br>Examination<br>Gloves Powder<br>Free (K192333) | Comparison |
| Dimensions<br>(ASTM D6319-<br>19) | Overall Length<br>(mm)<br>220 mm = (sizes<br>XS-S)<br>230 mm = (sizes M-<br>XL)<br>Width (± 10 mm)<br>Size S = 80 mm<br>Size M = 95 mm<br>Size L = 110 mm<br>Size XL = 120 mm<br>Thickness at Finger<br>(mm)<br>All Sizes = 0.05mm<br>Thickness at Palm<br>(mm)<br>All Sizes = 0.05mm | Length (mm)<br>220 mm = (sizes<br>XS-S)<br>230 mm = (sizes<br>M-XL)<br>Width (± 10 mm)<br>Size S = 80 mm<br>Size M = 95 mm<br>Size L = 110 mm<br>Size XL = 120<br>mm<br>Thickness-Finger<br>(mm)<br>All Sizes≥0.05mm<br>Thickness-Palm<br>(mm)<br>All Sizes≥0.05mm | Size: M<br>Length Min:<br>230mm<br>Palm Width Min:<br>95+/-10mm<br>Finger Thickness<br>min: 0.05 mm<br>Palm Thickness<br>min: 0.05 mm | Same |
| Physical<br>Properties | Tensile Strength<br>(MPa) = 14 min. | Before Aging ASTM D6319-19<br>Tensile Strength<br>(MPa)<br>> 14 min | Tensile Strength<br>(MPa)<br>> 14 min. | Same |

# Table II - Performance Testing Comparison Table of proposed device K210897 and predicate device K192333

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| | Ultimate Elongation<br>(%) = 500 min. | Ultimate<br>Elongation (%)<br>500 min. | Ultimate<br>Elongation (%)<br>500 min. | Same |
|---------------------------------------|---------------------------------------|--------------------------------------------|--------------------------------------------|------|
| | After Aging ASTM D6319-19 | | | |
| | Tensile Strength<br>(MPa) = 14 min. | Tensile Strength<br>(MPa)<br>$\ge$ 14 min. | Tensile Strength<br>(MPa)<br>$\ge$ 14 min. | Same |
| | Ultimate Elongation<br>(%) = 400 min. | Ultimate<br>Elongation (%)<br>400 min. | Ultimate<br>Elongation (%)<br>400 min. | Same |
| Freedom from<br>Holes<br>(ASTM D5151) | AQL 2.5 Inspection<br>Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual Power<br>(ASTM D6124) | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | $\le$ 2.0 mg/pc | Same |

Table III - Biocompatibility Testing Comparison Table

| Characteristics | Acceptance<br>Criteria | Proposed Device | Predicate<br>Device | |
|------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------|
| | | Disposable Nitrile<br>Examination<br>Gloves | Blue Nitrile<br>Examination<br>Gloves Powder<br>Free | Comparison |
| Biocompatibility | Primary Skin<br>Irritation Test<br>ISO 10993-10 | Under the<br>conditions of the<br>test, the test article<br>would be<br>considered a non-<br>irritant. | Under the<br>condition of<br>study not an<br>irritant. | Same |
| | Dermal<br>Sensitization<br>Assay<br>ISO 10993-10 | Under the<br>conditions of this<br>study, there is no<br>evidence of skin<br>sensitization in<br>guinea pigs was<br>found. | Under the<br>conditions of the<br>study not a<br>sensitizer. | Same |
| | Acute Systemic<br>Test<br>ISO 10993-11 | Under the<br>conditions of this<br>study, there is no<br>mortality or<br>evidence of<br>systemic toxicity<br>from the extracts. | Under the<br>condition of<br>study the device<br>extracts do not<br>pose a systemic<br>toxicity concern. | Same |

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| | The test met the test<br>requirements. | | |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Material<br>Mediated<br>Pyrogenicity<br>ISO 10993-11/<br>USP 41<151> | Under the<br>conditions of this<br>study, the test<br>article would be<br>considered no<br>febrile reaction. The<br>test article meets<br>the test<br>requirements. | Under the<br>conditions of the<br>study, the device<br>did not<br>demonstrate a<br>material<br>mediated<br>pyrogenicity<br>response. | Same |
| In Vitro<br>Cytotoxicity<br>ISO 10993-5 | Under the<br>conditions of this<br>study, the MEM test<br>extracts would be<br>considered<br>cytotoxic potential. | Under the<br>conditions of the<br>study, cytotoxic.<br>Additional<br>testing was<br>performed to<br>determine if this<br>was a systemic<br>toxicity concern. | Same |
| Intracutaneous<br>Reactivity Test<br>ISO 10993-10 | The test result<br>showed that the<br>polar and non-polar<br>extract of the final<br>test sample score is<br>less 1.0, the<br>requirements of the<br>test are met | Not available. | N/A |

# 9. Clinical Test

There is no clinical study included in this submission.

# 10. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K210897, the Disposable Nitrile Examination Gloves , is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K192333.