Nitrile Medical Examination Gloves

K221108 · Anhui Fulewei Electronic Technology Co.,Ltd · LZA · Jul 12, 2022 · General Hospital

Device Facts

• Record ID: K221108
• Device Name: Nitrile Medical Examination Gloves
• Applicant: Anhui Fulewei Electronic Technology Co.,Ltd
• Product Code: LZA · General Hospital
• Decision Date: Jul 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Nitrile Medical Examination Gloves; single-use, powder-free, non-sterile, ambidextrous patient examination glove made from nitrile compound. Worn by clinicians during patient examinations to provide a barrier against cross-contamination between patient and examiner. Device functions as a physical barrier; no electronic or software components. Used in clinical settings. Benefits include protection of both patient and examiner from potential contaminants during medical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19 standards, including freedom from holes (ASTM D5151), physical dimensions, physical requirements (tensile strength/elongation per ASTM D412/D573), and powder residue (ASTM D6124). Biocompatibility testing performed per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation/sensitization), and ISO 10993-11:2017 (systemic toxicity).

Technological Characteristics

Material: Nitrile compound. Form factor: Ambidextrous, single-use, powder-free glove. Sizes: S, M, L, XL. Standards: ASTM D6319-19, ASTM D5151, ASTM D412, ASTM D573, ASTM D6124. Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11. Non-sterile. No software, electronics, or energy source.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand to prevent contamination between patient and examiner. Intended for adult patient populations.

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 contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 12, 2022

Anhui Fulewei Electronic Technology Co.,Ltd Beina Gong Manager South Of Binheroad, West Of Gangkou Road, Economic Development Zone, Fuyang, Anhui 236000 China

Re: K221108

Trade/Device Name: Nitrile Medical Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 1, 2022 Received: April 15, 2022

Dear Beina Gong:

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 mediation-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.

Bifeng Qian, M.D., Ph.D. Acting 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) K221108

Device Name Nitrile Medical Examination Gloves

Indications for Use (Describe)

Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand 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 K221108

Prepared in accordance with the requirements of 21 CFR Part 807.92

#### Prepared Date: July 12, 2022

## 1. Submitter's Information

| Name: | ANHUI FULEWEI ELECTRONIC TECHNOLOGY CO., LTD |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Address: | SOUTH OF BINHEROAD, WEST OF GANGKOU ROAD,<br>ECONOMIC DEVELOPMENT ZONE, FUYANG CITY, ANHUI,<br>CHINA 236000 |
| Contact person: | Beina Gong |
| Title: | Manager |
| E-mail: | [e-mail] |
| Tel: | 86-15055553699 |

## 2. Device Identification

| Trade/Device Name: | Nitrile Medical Examination Gloves |
|--------------------|----------------------------------------|
| Size of glove | S, M, L, XL |
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Regulation Class: | Class I |
| Panel: | General Hospital |
| Product Code: | LZA |

### 3. Predicate Device

| 510(K) number: | K192333 |
|--------------------|---------------------------------------------------|
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Manufacturer: | JR Engineering & Medical Technologies (M) SDN.BHD |
| Common name | Polymer Patient Examination Glove |
| Regulation Number: | 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Regulation Class: | Class I |
| Panel: | General Hospital |
| Product Code: | LZA |

### 4. Device Description

Nitrile Medical Examination Gloves is a patient examination glove and it is made from nitrile compound. It is a single-use, powder-free and non-sterile product. The glove is worn on the 510(k) Summary Page 1 of Page 6

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examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.

# 5. Indication for use

Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

# 6. Summary of the technological characteristics of the device compared to the Predicate Device

Compared to the predicate device, the subject device has the same intended use, similar product design, and similar performance as the predicate device, the summarized comparison information is listed in the following table:

| SE Comparisons | | Subject Device<br>K221108 | Predicate Device<br>K192333 | Remarks |
|---------------------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Name | | Nitrile Medical<br>Examination Gloves | Blue Nitrile Examination<br>Gloves Powder Free | / |
| Size | | Small,<br>Medium, Large, Extra<br>Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | See Note1 |
| Classification | | Class I | Class I | Same |
| Intended use / indications for<br>use | | Nitrile Medical<br>Examination Gloves is<br>disposable device<br>intended for medical<br>purpose that is worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | JR MEDIC Blue Nitrile<br>Examination Gloves<br>Powder Free is<br>disposable devices<br>intended for medical<br>purpose that are worn on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | Same |
| Dimensions | ASTM<br>D6319- 19 | Length Min: 220mm<br>Width: 80±10mm<br>(for S size)<br>Length Min: 230mm<br>Width: 95±10mm<br>(for M size)<br>Length Min: 230mm<br>Width: 110±10mm<br>(for L size)<br>Length Min: 230mm<br>Width: 120±10mm<br>(for XL size) | Length Min 230 mm<br>Width Min 95±10mm<br>(for medium size) | Note1 |
| Physical<br>Properties | ASTM<br>D6319- 19 | Before Aging<br>Tensile Strength Min 14<br>Mpa | Before Aging<br>Tensile Strength Min 14<br>Mpa | Same |
| | | Ultimate Elongation Min<br>500%<br>After Aging<br>Tensile Strength Min 14<br>Mpa<br>Ultimate Elongation Min<br>400% | Ultimate Elongation Min<br>500%<br>After Aging<br>Tensile Strength Min 14<br>Mpa<br>Ultimate Elongation Min<br>400% | |
| Water leak | ASTM D6319-<br>19 | AQL 2.5 | AQL 2.5 | Same |
| Thickness | ASTM D6319-<br>19 | Palm Min 0.05 mm<br>Finger Min 0.05 mm | Palm Min 0.05 mm<br>Finger Min 0.05 mm | Same |
| Powder<br>Free | ASTM D6319-<br>19 | $≤$ 2 mg/glove | $≤$ 2 mg/glove | Same |
| Biocompat<br>ibility | ISO 10993-<br>10:2010 | Under the condition of<br>study not an<br>irritant | Under the condition of<br>study not an<br>irritant | Same |
| | ISO 10993-<br>10:2010 | Under the conditions of<br>the study not a sensitizer | Under the conditions of<br>the study not a sensitizer | Same |
| | ISO 10993-<br>5:2009 | Under the conditions of<br>the study,<br>cytotoxic.<br>Additional testing was<br>performed to determine if<br>this was a systemic<br>toxicity concern | Under the conditions of<br>the study,<br>cytotoxic.<br>Additional testing was<br>performed to determine if<br>this was a systemic<br>toxicity concern | Same<br>Note 2 |
| | ISO 10993-<br>11:2017 | Under the condition of<br>study the device extracts<br>do not pose a systemic<br>toxicity concern | Under the condition of<br>study the device extracts<br>do not pose a systemic<br>toxicity concern | Same<br>Note 2 |
| | ISO 10993-<br>11:2017 | / | Under the conditions of<br>the study, the device did<br>not demonstrate a<br>material mediated<br>pyrogenicity response. | Note 3 |
| Single Use | | Yes | Yes | Same |
| Non-Sterile | | Yes | Yes | Same |
| Color | | Blue | Blue | Same |
| Intended use population | | Adult | Adult | Same |
| Wear | | ambidextrous | ambidextrous | Same |
| EXPIRE DATE | | Not claim | Included | See Note<br>4 |

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Note 1:

In this submission, the sizes "S, M, L and XL" of Nitrile Medical Examination Gloves have been performed the testing according to the ASTM D6319-19, the dimension and performance meet the requirements of ASTM D6319-19, the difference in sizes does not raise different questions of safety and effectiveness.

Note 2:

We evaluated In vitro cytotoxicity in accordance with ISO 10993-5:2009, the result demonstrated toxicity to L929 cells. Additionally, we evaluated acute systemic toxicity in accordance with ISO 10993-11:2017. Under the conditions of the study, there was no evidence of systemic toxicity from the test article extract. Similar to the predicate device, the proposed device met the requirements of the study.

Note 3:

We do not claim "non-pyrogenic" and we evaluated the biocompatibility per ISO 10993-1, the material mediated pyrogenicity testing is unnecessary.

Note 4: According to FDA guidance, claiming shelf life is non-mandatory.

#### 7. Performance Data

#### Clinical test:

Clinical testing is not required.

#### Non-clinical data

The following bench testing was conducted.

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical 1. Application.

Freedom from Holes - Testing for freedom from holes was conducted in accordance with 2. Test Method ASTM D5151.

3. Physical Dimension test - Determine the dimension as directed in Table 2 of ASTMD6319-19.

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4. Physical Requirement Test - Before and accelerated aging, the physical requirement specified in Table 3 of ASTM D6319-19, tests were conducted in accordance with test method ASTM D412 and accelerated aging test were conducted in accordance with Test Method ASTMD573.

5. Powder Free Gloves - Determine the powder residue in accordance with Test Method

- ASTM D6124.

| Stand | Test item | Test | Criteria | Result | Conclusion |
|----------------------|---------------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| ard | | method | | | |
| ASTM<br>D6319<br>-19 | freedom<br>from holes | ASTM D5151 | Any glove that shows a<br>droplet, stream, or<br>other type of water<br>leakage shall be<br>considered to have<br>failed the test.<br>AQL 2.5 | Did not show a<br>droplet, stream,<br>or other type of<br>water leakage | 200<br>samples<br>tested<br>0 failures<br>Pass |
| | Physical<br>Dimension<br>test | ASTM D412<br>ASTM<br>D3767 | Length Min:220mm<br>Width Min:80±10mm<br>(for S size)<br>Length Min:230mm<br>Width Min:95±10mm<br>(for M size)<br>Length Min:230mm<br>Width Min:110±10mm<br>(for L size)<br>Length Min:230mm<br>Width Min:120±10mm<br>(for XL size)<br>Thickness: Finger<br>0.05min<br>Palm 0.05min | Length:<br>241~246mm<br>Width: 85~88mm<br>(for S size)<br>Length:<br>243~252mm<br>Width: 92~94mm<br>(for M size)<br>Length:<br>287~298mm<br>Width:<br>109~110mm<br>(for L size)<br>Length:<br>288~292mm<br>Width:<br>114~117mm<br>(for XL size)<br>Thickness:<br>Finger<br>0.08~0.125mm<br>Palm<br>0.063~0.082mm | 13 samples<br>tested/size<br>0 failure<br>Pass |
| | Physical<br>Requirement<br>Test | ASTM<br>D412<br>ASTM<br>D573 | Tensile Strength:<br>Before Aging 14 Mpa,<br>min.<br>After Aging 14 Mpa,<br>min.<br>Elongation:<br>Before Aging 500%<br>min.<br>After Aging 400% min. | Tensile Strength:<br>Before Aging<br>19.6~26.7 Mpa,<br>After Aging<br>20.9~26.1 Mpa,<br>Elongation:<br>Before Aging<br>650~700%<br>After Aging<br>560~620% | 13 samples<br>tested/L<br>size<br>0 failure<br>Pass |
| | Powder<br>Free Gloves | ASTM D6124 | Max. 2.0mg | sample quantity:<br>5pcs<br>Average: 1.9 mg | Pass |

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Biocompatibility:

1. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic ನ toxicity.

3. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 Tests for In vitro cytotoxicity

| Test item | Test Standard | Criteria | Results |
|----------------------------|--------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | Under conditions of the<br>study, the test article<br>must not show potential<br>toxicity. | Fail—<br>Under the condition of<br>the test, the test article<br>was found to be<br>cytotoxic |
| Skin Sensitization | ISO 10993-10: 2010 | Under the conditions<br>of the study, the test<br>article must be found<br>to be non-sensitizing. | Pass—<br>Under the condition of<br>the test, the test article<br>was found to be non-<br>sensitizing |
| Skin Irritation test | ISO 10993-10: 2010 | Under the conditions<br>of the test, the test<br>article must be found<br>to be non- irritating | Pass—<br>Under the conditions of<br>the test, the test article<br>was found to be non-<br>irritating |
| Acute systemic<br>toxicity | ISO 10993-11:2017 | Under the conditions<br>of the test, the test<br>article must be found<br>to be non- systemic<br>toxicity | Pass—<br>Under the condition of<br>the test, the test article<br>was found to be non-<br>systemic toxicity |

### 8. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the predicated device(K192333).