Nitrile examination gloves

K211927 · Fitone Latex Products Co., Ltd. Guangdong · LZA · Oct 12, 2021 · General Hospital

Device Facts

• Record ID: K211927
• Device Name: Nitrile examination gloves
• Applicant: Fitone Latex Products Co., Ltd. Guangdong
• Product Code: LZA · General Hospital
• Decision Date: Oct 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Story

Nitrile examination gloves (Model NG100); blue, powder-free, non-sterile, disposable. Features smooth surface, textured fingertips, rolled rim cuff. Available in XS, S, M, L, XL sizes. Used by healthcare examiners in clinical settings to provide barrier protection against contamination between patient and examiner. Device functions as physical barrier; no active components or software.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (tensile strength, elongation), freedom from holes (ASTM D5151), residual powder (ASTM D6124), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Material: Nitrile rubber. Design: Powder-free, non-sterile, textured fingertips, rolled rim. Standards: ASTM D6319-19 (dimensions/physical properties), ASTM D5151-19 (holes), ASTM D6124-06 (powder), ASTM D573-04 (aging), ASTM D412-16 (tension), ISO 10993-5/10 (biocompatibility). No energy source, software, or connectivity.

Indications for Use

Indicated for use on the hands of examiners to prevent contamination between patient and examiner. Intended for single-use, non-sterile, over-the-counter application.

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

• Nitrile examination gloves (K203593)

Submission Summary (Full Text)

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October 12, 2021

Fitone Latex Products Co., Ltd. Guangdong % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, 555 West Guangzho Shanghai. 200072 China

Re: K211927

Trade/Device Name: 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: September 7, 2021 Received: September 7, 2021

Dear Stuart Situ:

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

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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, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K211927

Device Name Nitrile examination gloves

Indications for Use (Describe)

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

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

#### l. Submitter

Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China

Contact person: Christine Ou Position: Manager Tel.: [phone] E-mail: [e-mail]

Preparation date: Jun.11, 2021

## US Agent

Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476

#### II. Proposed Device

| Device Trade Name | Nitrile examination gloves |
|--------------------|-----------------------------------|
| Model | NG100 |
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA |
| Review Panel | General Hospital |

#### III. Predicate Devices

| 510(k) Number: | K203593 |
|-----------------|-------------------------------------|
| Trade name: | Nitrile examination gloves |
| Common name: | Polymer Patient Examination Glove |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer | GUANGDONG KINGFA SCI.&TECH.CO.,LTD. |

#### IV. Device description

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The propose device (Mode: NG100) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, includes XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.

The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.

#### V. Indication for use

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

## VI. Comparison of technological characteristics with the predicate devices

| Item | Standard | Proposed device<br>(K211927) | Predicate device<br>(K203593) | Discussion |
|-----------------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Product name | / | Nitrile Examination<br>Gloves | Nitrile Examination<br>Gloves | - |
| Product Code | / | LZA | LZA | Same |
| Regulation No. | / | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | / | Class I | Class I | Same |
| Powder free | / | Yes | Yes | Same |
| Indication for<br>use | / | The nitrile<br>examination glove is<br>intended to be worn<br>on the hands of<br>examiner's to prevent<br>contamination<br>between patient and<br>examiner. This is a<br>single-use,<br>powder-free,<br>non-sterile device. | The nitrile<br>examination glove is<br>intended to be worn<br>on the hands of<br>examiner's to prevent<br>contamination<br>between patient and<br>examiner. This is a<br>single-use,<br>powder-free,<br>non-sterile device. | Same |
| Main Material | / | Nitrile rubber | Nitrile rubber | Same |
| Color | / | Blue | Blue | Similar* |
| Size | / | X-small, Medium, large | Small, Large, X large | Similar Dimensions meet ASTM D6319-19 |
| Palm width | ASTM D6319-19 | XS (70±10mm)<br>S (80±10mm)<br>M (95±10mm)<br>L (110±10mm)<br>XL (120±10mm) | Small (80±10mm)<br>Medium (95±10mm)<br>Large (110±10mm)<br>X large (120±10mm) | Similar Dimensions meet ASTM D6319-19 |
| Length | ASTM D6319-19 | XS (220mm min)<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min) | S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min) | Similar Dimensions meet ASTM D6319-19 |
| Thickness | ASTM D6319-19 | Palm: 0.05mm min<br>Finger: 0.05mm min | Palm: 0.05mm min<br>Finger: 0.05mm min | Same |
| Freedom from holes | ASTM D5151-06 | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151 | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151 | Same |
| Physical Properties (before aging) | ASTM D6319-19 | Tensile Strength:<br>14MPa, min<br>Ultimate Elongation:<br>500% min | Tensile Strength:<br>14MPa, min<br>Ultimate Elongation:<br>500% min | Same |
| Physical Properties (after aging) | ASTM D6319-19 | Tensile Strength:<br>14MPa, min<br>Ultimate Elongation:<br>400% min | Tensile Strength:<br>14MPa, min<br>Ultimate Elongation:<br>400% min | Same |
| Powder residual | ASTM D6124 | ≤2.0 mg/gloves | | Same |
| Sterility | / | Non-sterile | Non-sterile | Same |
| For single use | / | Yes | Yes | Same |
| Type of use | / | Over the counter use | Over the counter use | Same |
| Shelf-life | / | 3 years | 3 years | The shelf-life testing was |
| | | | | performed<br>that<br>demonstrate<br>meet the<br>claimed<br>shelf-life. |
| Biocompatibility<br>- Skin<br>Sensitization<br>Test | ISO<br>10993-10 | Under the test<br>condition of study not<br>an sensitizer | Under the test<br>condition of study not<br>an sensitizer | Same |
| Biocompatibility<br>- Skin Irritation<br>Test | ISO<br>10993-10 | Under the test<br>condition of study not<br>an irritant | Under the test<br>condition of study not<br>an irritant | Same |
| Biocompatibility<br>- Cytotoxicity<br>Test | ISO<br>10993-5 | Under the test<br>conditions, the test<br>article was<br>non-cytotoxic to L-929<br>cells. | Cytotoxicity is<br>assessed via<br>rationale. Under the<br>condition of acute<br>systemic toxicity test,<br>the test article did not<br>show acute systemic<br>toxicity in vivo. | Different |

#### Table 1 Comparison of Nitrile examination gloves

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*As above comparison, the difference in the dimensions and reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.

# VII. Non-Clinical Testing

Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.

- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- ASTM D5151-19,Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves ●
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in an Air Oven ●
- ASTM D412-16, Test Methods for Vulcanized Rubber and Thermoplastic ● Elastomers-Tension

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- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cytotoxicity
- . ISO 10993-10: 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

# VIII. Clinical Testing

No clinical study is included in this submission.

## IX. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Nitrile Patient Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K203593.