Nitrile Examination Gloves (Blue, Violet)

K211586 · Lyncmed Medical Technology (Beijing) Co., Ltd. · LZA · Nov 1, 2021 · General Hospital

Device Facts

• Record ID: K211586
• Device Name: Nitrile Examination Gloves (Blue, Violet)
• Applicant: Lyncmed Medical Technology (Beijing) Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Nitrile examination gloves; non-sterile; disposable; worn on examiner's hands. Function: physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. No electronic or software components. Device provides protection via material properties (nitrile rubber).

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ASTM D6319 (dimensions, physical properties), ASTM D5151 (freedom from holes), and ASTM D6124 (residual powder). Biocompatibility verified per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, non-sterile, powder-free gloves. Sizes: XS, S, M, L, XL. Standards: ASTM D6319, ASTM D5151, ASTM D6124. Biocompatibility: ISO 10993-10, ISO 10993-11. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a non-sterile, disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner.

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

• POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) (K150340)

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.

Nov 1, 2021

Lyncmed Medical Technology (Beijing) Co., Ltd. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K211586

Trade/Device Name: Nitrile Examination Gloves (Blue, Violet) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 15, 2021 Received: September 22, 2021

Dear Ray Wang:

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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K211586

Device Name

Nitrile Examination Gloves (Blue, Violet)

Indications for Use (Describe)

The Nitrile Examination Gloves is a non-sterile 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)

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

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# 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K211586

- 1. Date of Preparation: 10/30/2021
- 2. Sponsor

### Lyncmed Medical Technology (Beijing) Co., Ltd.

Room 1601, Building No. 2, Zhubang 2000 Business Building, Balizhuangxili 99, Chaoyang District, BeiJing, P.R. China 100022

Contact Person: Jiali Zhou Position: Regulation Affair Manager Tel: [phone] Email: [e-mail]

- 3. Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

Mr. Ray Wang Tel: [phone] Fax: [phone] Email: ray.wang(@believe-med.com

- Proposed Device Identification 4.
Trade Name: Nitrile Examination Gloves (Blue, Violet) Common Name: NITRILE Patient Examination Gloves (Powder Free)

Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

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Indication For Use Statement:

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

- 5. Predicate Device Identification
510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD

- Device Description 6.
The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet.

The proposed device is not provided as sterilized The proposed device is made of Nitrile.

| | Size | | | | | |
|-------------|------|----------------|-----|-----|-----|-----------|
| Designation | XS | S | M | L | XL | Tolerance |
| Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | | Thickness, mm: | | | | |
| Finger | 0.05 | | | | | min |
| Palm | 0.05 | | | | | min |

#### Table 1 Device Size Specifications

| Before Aging | After Aging | Pinhole AQL | | |
|---------------------|------------------------|---------------------|------------------------|-----|
| Tensile<br>Strength | Ultimate<br>Elongation | Tensile<br>Strength | Ultimate<br>Elongation | 1.5 |
| 14 MPa, min | 500 % min | 14 MPa, min | 400 % min | |

The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.

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## 7. Comparison of Technological Characteristics

| ITEM | Proposed Device (K211586)<br>Nitrile Examination Gloves (Blue, Violet) | Predicate Device (K150340)<br>POWDER FREE Nitrile GLOVES (White,<br>Cobalt Blue, Black, Ice Blue) | Remark |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Nitrile Examination Gloves is a<br>non-sterile disposable device intended for<br>medical purpose that is worn on the<br>examiner's hand to prevent contamination<br>between patient and examiner. | The POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's<br>hands to prevent contamination between<br>patient and examiner. | SAME |
| Powdered or<br>Powered free | Powdered free | Powdered free | SAME |

# Table 1 General Comparison

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| Proposed Device (K211586)<br>Nitrile Examination Gloves<br>(Blue, Violet) | | Size | | | | | Tolerance |
|------------------------------------------------------------------------------------------------------|-------------|----------------|-----|-----|-----|-----|-----------|
| | Designation | XS | S | M | L | XL | |
| | Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | | Thickness, mm: | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| Predicate Device (K150340)<br>POWDER FREE Nitrile<br>GLOVES (White, Cobalt Blue,<br>Black, Ice Blue) | | Size | | | | | Tolerance |
| | Designation | XS | S | M | L | XL | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | | Thickness, mm: | | | | | |
| | Finger | 0.10-0.12 | | | | | ±0.03 |
| | Palm | 0.08-0.10 | | | | | ±0.03 |

Table 2 Device Dimensions Comparison

Different Analysis 1:

The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319.

| ITEM | Proposed Device (K211586)<br>Nitrile Examination Gloves (Blue,<br>Violet) | Predicate Device (K150340)<br>POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice<br>Blue) | Remark | | |
|------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------|-------------|-------------------------|
| Colorant | Blue, Violet | White, Cobalt Blue, Black, Ice Blue | Different<br>Analysis 2 | | |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa, min | 15 MPa, min | Different<br>Analysis 1 |
| | | Ultimate<br>Elongation | 500 % min | 500 % min | SAME |
| | After<br>Aging | Tensile<br>Strength | 14 MPa, min | 14 MPa, min | SAME |
| | | Ultimate | 400 % min | 400 % min | SAME |

Table 3 Performance Comparison

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| | | Elongation | | | | |
|--------------------|--|------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|------------------------|------|
| | | Comply with ASTM D6319 | | | Comply with ASTM D6319 | SAME |
| Freedom from Holes | | | Be free from holes when tested in<br>accordance with ASTM D5151 | Be free from holes when tested in<br>accordance with ASTM D5151 | SAME | |
| | | | | | | |
| Powder Content | | | Less than 2 mg per glove when tested<br>in accordance with ASTM D6124 | Meet the requirements of<br>ASTM D6124 | SAME | |

Different Analysis 2:

The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-10, the test results showed that the proposed devices with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization.

| ITEM | | Proposed Device (K211586)<br>Disposable Nitrile Examination<br>Gloves (Blue, Violet) | Predicate Device (K150340)<br>POWDER FREE Nitrile GLOVES<br>(White, Cobalt Blue, Black, Ice Blue) | Remark |
|------------------|-----------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------|
| Material | | Nitrile | Nitrile | SAME |
| Biocompatibility | Irritation | Under the conditions of the study,<br>not an irritant | Under the conditions of the study,<br>not an irritant | SAME |
| | Sensitization | Under conditions of the study, not a<br>sensitizer. | Under conditions of the study, not a<br>sensitizer. | |
| | Acute System toxicity | Under the conditions of study, no<br>mortality or evidence of systemic<br>toxicity | N.A | Different<br>Analysis 3 |
| | Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME |

#### Table 4 Safety Comparison

Different Analysis 3:

The proposed device has conducted the systemic toxicity testing than predicated device for toxicity evaluation, the test results shown that there were no mortality or evidence of systemic toxicity.

8. Summary of Non-Clinical performance testing

The test results demonstrated that the proposed device complies with the following 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 D6124-17, 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. ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

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Please add a table here. The table should include four columns: Test method, purpose, acceptance criteria and results.

| Table 5 Performance Test Results Summary | | | |
|------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Method | Purpose | Acceptance Criteria | Results |
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes<br>AQL 2.5 | Blue Color:<br>No water leakage is inspected form 200 samples<br>Violet Color:<br>No water leakage is inspected form 200 samples |
| ASTM D6124 | Determine the powder residue for powder free gloves | <2.0 mg per glove | Blue Color:<br>Residual Powder: Average 0.05 – 0.10 mg;<br>Violet Color:<br>Residual Powder: Average 0.04 – 0.10 mg; |
| ASTM D412<br>ASTM D573 | Testing for Physical property characteristics | Before Aging<br>Tensile Strength: 14 MPa min.<br>Ultimate Elongation: 500% min. | Blue Color: |
| | | Before Aging<br>Tensile Strength: 14 MPa min.<br>Ultimate Elongation: 400% min. | XS Before Aging<br>Tensile Strength: ≥ 31.1 MPa;<br>Ultimate Elongation: ≥ 505 %.<br>After Aging<br>Tensile Strength: ≥ 30.1 MPa;<br>Ultimate Elongation: ≥ 460%.<br>S Before Aging<br>Tensile Strength: ≥ 31.3 MPa;<br>Ultimate Elongation: ≥ 507 %.<br>After Aging<br>Tensile Strength: ≥ 32.1 MPa;<br>Ultimate Elongation: ≥ 457%.<br>M Before Aging<br>Tensile Strength: ≥ 31.2 MPa;<br>Ultimate Elongation: ≥ 506 %.<br>After Aging<br>Tensile Strength: ≥ 28.2 MPa;<br>Ultimate Elongation: ≥ 447%.<br>L Before Aging<br>Tensile Strength: ≥ 30.9 MPa;<br>Ultimate Elongation: ≥ 506 %.<br>After Aging<br>Tensile Strength: ≥ 27.9 MPa;<br>Ultimate Elongation: ≥ 426%.<br>XL Before Aging<br>Tensile Strength: ≥ 31.0 MPa;<br>Ultimate Elongation: ≥ 508 %.<br>After Aging<br>Tensile Strength: ≥ 25.1 MPa;<br>Ultimate Elongation: ≥ 408%.<br>Violet Color:<br>XS Before Aging<br>Tensile Strength: ≥ 24.1 MPa;<br>Ultimate Elongation: ≥ 510 %.<br>After Aging<br>Tensile Strength: ≥ 28.6 MPa;<br>Ultimate Elongation: ≥ 408%.<br>S Before Aging<br>Tensile Strength: ≥ 26.5 MPa;<br>Ultimate Elongation: ≥ 515 %.<br>After Aging<br>Tensile Strength: ≥ 29.8 MPa;<br>Ultimate Elongation: ≥ 436%.<br>M Before Aging<br>Tensile Strength: ≥ 26.3 MPa;<br>Ultimate Elongation: ≥ 515 %.<br>After Aging<br>Tensile Strength: ≥ 26.7 MPa;<br>Ultimate Elongation: ≥ 462%.<br>L Before Aging<br>Tensile Strength: ≥ 25.9 MPa; |

| | | | Table 5 Performance Test Results Summary | | | | |
|--|--|--|------------------------------------------|--|--|--|--|
| | | | | | | | |

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| ASTM D412<br>ASTM D3767 | Testing For physical<br>dimensions specification | Length: 220 mm min. for size (XS, S);<br>Length: 230 mm min. for size (M, L, XL);<br>70±10 mm for XS; 80±10 mm for S;<br>95±10 mm for M; 110±10 mm for L;<br>120±10 mm for XL.<br>Finger Thickness: ≥0.05 mm;<br>Palm Thickness: ≥0.05 mm;<br>All acceptance criteria above meet the<br>requirements in Table 1 Dimensions and<br>Tolerances of ASTM D6319 | XL Ultimate Elongation: ≥ 510 %.<br>After Aging<br>Tensile Strength: ≥ 25.6 MPa;<br>Ultimate Elongation: ≥ 457%.<br>Before Aging<br>Tensile Strength: ≥ 26.5 MPa;<br>Ultimate Elongation: ≥ 517 %.<br>After Aging<br>Tensile Strength: ≥ 25.0 MPa;<br>Ultimate Elongation: ≥ 453%.<br>Blue Color:<br>Length of Size XS: ≥ 225mm;<br>Width of Size XS: 70±8 (77-78) mm;<br>Palm Thickness of Size S: ≥0.06 mm;<br>Finger Thickness of Size S: ≥0.07 mm.<br>Length of Size S: ≥ 246mm;<br>Width of Size S: 80±7 (86-87) mm;<br>Palm Thickness of Size S: ≥0.06 mm;<br>Finger Thickness of Size S: ≥0.07 mm.<br>Length of Size M: ≥ 240 mm;<br>Width of Size M: 95±4 (98-99) mm;<br>Palm Thickness of Size M: ≥0.06 mm;<br>Finger Thickness of Size M: ≥0.08 mm.<br>Length of Size L: ≥ 243mm;<br>Width of Size L: 110±3 (107-108) mm;<br>Palm Thickness of Size L: ≥0.06 mm;<br>Finger Thickness of Size L: ≥0.08 mm.<br>Length of Size XL: ≥ 243mm;<br>Width of Size XL: 120±6 (114-116) mm;<br>Palm Thickness of Size XL: ≥0.06 mm;<br>Finger Thickness of Size XL: ≥0.08 mm.<br>Violet Color:<br>Length of Size XS: ≥ 225mm;<br>Width of Size XS: 70±8 (77-78) mm;<br>Palm Thickness of Size S: ≥0.06 mm;<br>Finger Thickness of Size S: ≥0.07 mm.<br>Length of Size S: ≥ 246mm;<br>Width of Size S: 80±7 (86-87) mm;<br>Palm Thickness of Size S: ≥0.06 mm;<br>Finger Thickness of Size S: ≥0.07 mm.<br>Length of Size M: ≥ 240 mm;<br>Width of Size M: 95±4 (98-99) mm;<br>Palm Thickness of Size M: ≥0.06 mm;<br>Finger Thickness of Size M: ≥0.08 mm.<br>Length of Size L: ≥ 242mm;<br>Width of Size L: 110±3 (107-108) mm;<br>Palm Thickness of Size L: ≥0.06 mm;<br>Finger Thickness of Size L: ≥0.08 mm.<br>Length of Size XL: ≥ 243mm;<br>Width of Size XL: 120±6 (114-116) mm;<br>Palm Thickness of Size XL: ≥0.06 mm;<br>Finger Thickness of Size XL: ≥0.08 mm. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-11 | Evaluate the endpoint of<br>Systemic toxicity for<br>biocompatibility | The test article showed no evidence of<br>systemic toxicity potential from the<br>extract. | The test article showed no evidence of<br>systemic toxicity from the extract. |
| ISO 10993-10 | Evaluate the endpoint of<br>irritant for<br>biocompatibility<br>Evaluate the endpoint of<br>sensitization for<br>biocompatibility | The response of the test article extract is<br>negligible.<br>The test article showed no evidence of<br>causing delayed dermal contact sensitization. | The test result showed that the response of the<br>test article extract was categorized as<br>negligible under the test condition.<br>The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |

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### 9. Conclusion:

Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) cleared under K150340.