Disposable Nitrile Examination Gloves

K203436 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · LZA · Apr 28, 2021 · General Hospital

Device Facts

• Record ID: K203436
• Device Name: Disposable Nitrile Examination Gloves
• Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn on examiner's hands; barrier protection to prevent cross-contamination between patient and examiner. Ambidextrous design; non-sterile; powder-free. Used in clinical or general medical settings. Provides physical barrier; reduces risk of pathogen transmission. Benefits patient and clinician by maintaining hygiene standards during examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319 (physical properties, dimensions), ASTM D5151 (freedom from holes), and ASTM D6124 (residual powder). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, non-sterile, powder-free gloves. Dimensions: XS-XL sizes. Standards: ASTM D6319, ASTM D5151, ASTM D6124. Biocompatibility: ISO 10993-5, ISO 10993-10. Energy source: None (manual). Connectivity: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent contamination between patient and examiner. Suitable for use by healthcare professionals and in over-the-counter settings.

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

• Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color (K171422)

Submission Summary (Full Text)

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April 28, 2021

Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K203436

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: March 18, 2021 Received: March 25, 2021

Dear Boyle 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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

# Bifeng Qian -S

For Ryan Ortega, 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 Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K203436

Device Name Disposable Nitrile Examination Gloves

Indications for Use (Describe)

The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands 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 K203436

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

# 1.0 submitter's information

Shandong Zhushi Pharmaceutical Group Co., Ltd Name: Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Phone Number: [phone] Contact: Junhui Zhu Date of Preparation: Apr. 27th, 2021

## Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: [phone] Email: [e-mail]

# 2.0 Device information

Trade name: Disposable Nitrile Examination Gloves

Common name: Patient Examination Gloves

Classification name: Non-powdered patient examination glove

XS, S, M, L, XL Model(s): 3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

## 4.0 Predicate device information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Disposable Powder Free Nitrile Examination Glove, White/ Device: Blue/ Black/ Pink Color

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#### 510(k) number: K171422

#### 5.0 Intended use

The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

#### 6.0 Device description

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

#### 7.0 Summary comparing technological characteristics with predicate device

| Item | Proposed device | Predicated device | Remark |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 510(k) number | K203436 | K171422 | Same |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable Nitrile<br>Examination Gloves is a<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | The Disposable Powder<br>Free Nitrile Examination<br>Glove, White/ Blue/ Black/<br>Pink Color is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, Disposable<br>Nitrile Examination Gloves,<br>Non-Sterile | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, Disposable<br>Powder Free Nitrile<br>Examination Glove,<br>Non-Sterile | Same |

#### Table1-General Comparison

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| Predicate | Designation | Size | | | | Tolerance | |
|-----------------|----------------|------|-----|-----|-----|-----------|-----|
| Device(K171422) | | XS | S | M | L | XL | |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | min | |
| | Palm | 0.05 | | | | min | |
| Proposed Device | Designation | Size | | | | Tolerance | |
| | | XS | S | M | L | XL | |
| | Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 90 | 100 | 115 | ±5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | min | |
| | Palm | 0.05 | | | | min | |
| Remark | SIMILAR | | | | | | |

#### Table 2 Device Dimensions Comparison

#### Table3 Performance Comparison

| Item | | Proposed device | Predicated device | Remark |
|------------------------|-----------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-----------|
| Colorant | | blue | White/ Blue/ Black/ Pink | Analysis1 |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength<br>14MPa, min | 14MPa, min | SAME |
| | | Ultimate<br>Elongation<br>500%min | 500%min | SAME |
| | After<br>Aging | Tensile<br>Strength<br>14MPa, min | 14MPa, min | SAME |
| | | Ultimate<br>Elongation<br>400%min | 400%min | SAME |
| | | Comply with ASTM D6319 | Comply with ASTM D6319 | SAME |
| Freedom from Holes | | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | SAME |
| Powder Content | | 0.02 | Meet the requirements of ASTM D6124 | SIMILAR |

Analysis1: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility and performance tests, the test results shown that the color difference does not affect the safety and efficacy of proposed device.

#### Table4 Biocompatibility Testing Comparison

| Item | Proposed device | Predicated device | Remark |
|----------|-----------------|-------------------|--------|
| Material | Nitrile | Nitrile | SAME |

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| Biocompatibility | Irritation | | | with | Similar |
|--------------------|---------------|--------------------------------------------------------------------------------|---------------------|-------|---------|
| | Irritation | Under the conditions of the study, not an irritant | | | |
| | Sensitization | Under conditions of the study, not a sensitizer. | | | |
| | Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. | | with | SIMILAR |
| Label and Labeling | | Meet FDA's Requirement | Meet<br>Requirement | FDA's | SAME |

#### 8.0 Summary of Non-Clinical Performance Testing

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

| No. | Name of the Test<br>Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-10:2010<br>Biological Evaluation Of<br>Medical Devices - Part<br>10: Tests For Irritation<br>And Skin Sensitization. | This part of ISO<br>10993 assesses<br>possible contact<br>hazards from<br>chemicals<br>released from<br>medical devices,<br>which may<br>produce skin and | Skin Sensitization<br>Test:<br>provided<br>grades less than 1,<br>otherwise<br>sensitization. | All grades are 0.<br>All animals were survived and no<br>abnormal signs were observed<br>during the study. |
| 2 | | mucosal irritation,<br>eye irritation or<br>skin sensitization. | Skin Irritation Test:<br>If the primary irritation<br>index is 0-0,4, the<br>response category is<br>Negligible.<br>0,5-1,9 means slight<br>2-4,9 means moderate<br>5-8 means severe | The primary irritation index is 0.<br>The response of the proposed<br>device was categorized as<br>negligible under the test<br>condition |
| 3 | ISO 10993-5:2009<br>Biological Evaluation Of<br>Medical Devices - Part<br>5: Tests For In Vitro<br>Cytotoxicity | This part of ISO<br>10993 describes<br>test methods to<br>assess the in vitro<br>cytotoxicity of<br>medical devices. | The viab.% of the<br>100% extract of the<br>test article is the final<br>result, and if viability is<br>reduced to <70% of<br>the blank, it has<br>cytotoxic potential. | Viab.% of 100% test article<br>extract is 70.9%<br>It means the proposed device<br>have no potential toxicity to L-<br>929 in the MTT method |
| 4 | ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | This standard is<br>designed to<br>determine the<br>amount ofresidual<br>powder (or filter-<br>retained mass)<br>found<br>on medical gloves | powder residue limit of<br>2.0 mg | 0.02mg |
| 5 | ASTM<br>D5151-<br>06(Reapproved2015),<br>Standard Test Method<br>for Detection of Holes in<br>Medical Gloves. | This test method<br>covers the<br>detection of holes<br>in<br>medical gloves. | Samples number: 125<br>gloves<br>AQL: 2.5 (ISO 2859)<br>Criterion ≤7 gloves for<br>water leakage | no glove water leakage found |
| 6 | ASTM<br>D6319-<br>10(Reapproved<br>2015),Standard<br>Specification For Nitrile<br>Examination Gloves For<br>Medical Application. | This specification<br>covers certain<br>requirements for<br>nitrile rubber<br>gloves used in<br>conducting<br>medical<br>examinations and<br>diagnostic and<br>therapeutic<br>procedures. | 1. Sterility: no need<br>2. Freedom<br>from<br>holes: pl. Refer to No.<br>5 in table 5<br>3. Dimensions:<br>XS: width 70±10mm<br>Length ≥220 mm<br>S: width 80±10mm<br>Length ≥220 mm<br>M: width 95±10mm<br>Length ≥230 mm<br>L: width 110±10mm<br>Length ≥220 mm<br>XL: width 75±6mm<br>Length ≥220 mm<br>Thickness:<br>Finger ≥0.05 mm<br>Palm ≥0.05 mm<br>4. Physical properties:<br>Before aging<br>Tensile strength ≥<br>14MPa<br>Ultimate Elongation ≥<br>500%<br>After Accelerated<br>Aging<br>Tensile strength ≥<br>14MPa<br>Ultimate Elongation ≥<br>400%<br>5. Powder-free<br>Residue:<br>pl. Refer to No. 4 in<br>table 5 | 1. N.A.<br>2. Please refer to No. 5 in table 5<br>3. Dimensions:<br>XS: Average width 71.38 mm<br>Average Length 221.25 mm<br>Thickness:<br>Average Finger 0.05 mm<br>Average Palm 0.07 mm<br>S: Average width 82.63 mm<br>Average Length 221.12 mm<br>Thickness:<br>Average Finger 0.055 mm<br>Average Palm 0.066 mm<br>M: Average width 93.4 mm<br>Average Length 232.13 mm<br>Thickness:<br>Average Finger 0.053 mm<br>Average Palm 0.079 mm<br>L: Average width 102.75mm<br>Average Length 231.4 mm<br>Thickness:<br>Average Finger 0.054 mm<br>Average Palm 0.076 mm<br>XL: Average width 115.4mm<br>Average Length 231.7 mm<br>Thickness:<br>Average Finger ≥0.054 mm<br>Average Palm ≥0.08 mm<br>4. Physical properties:<br>Before aging<br>Average Tensile strength 25.4<br>MPa<br>Average Ultimate Elongation ≥<br>608%<br>After Accelerated Aging<br>Average Tensile strength 25MPa<br>Average Ultimate Elongation<br>505%<br>5. Powder-free Residue:<br>pl. Refer to No. 4 in table 5 |

#### Table 5 Summary of Non-Clinical Performance Testing

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# 9. Summary of Clinical Performance Test

No clinical study is included in this submission.

# 10.0 Conclusion

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The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.