Disposable Nitrile Powder-Free Examination Gloves

K221192 · Shandong Maida Medical Technology Co., Ltd. · LZA · Jun 22, 2022 · General Hospital

Device Facts

• Record ID: K221192
• Device Name: Disposable Nitrile Powder-Free Examination Gloves
• Applicant: Shandong Maida Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are 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. Non-sterile; ambidextrous design; blue color. Used in clinical or general medical settings. Protects both patient and healthcare provider by providing a physical barrier against contaminants. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via compliance with ASTM D6319 (physical properties, dimensions), ASTM D5151 (freedom from holes), and ASTM D6124 (residual powder). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, blue. Standards: ASTM D6319, ASTM D5151, ASTM D6124. Biocompatibility: ISO 10993-5, 10, 11. Non-sterile. No energy source or software.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hands to prevent contamination between patient and examiner. Suitable for use by clinicians and for over-the-counter use.

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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June 22, 2022

Shandong Maida Medical Technology Co.,Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608.No.738.Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K221192

Trade/Device Name: Disposable Nitrile Powder-Free 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 18, 2022 Received: April 25, 2022

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 ([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 Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K221192

Device Name

Disposable Nitrile Powder-Free Examination Gloves

Indications for Use (Describe)

The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are 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 K221192

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

#### 1.0 submitter's information

Name: Shandong Maida Medical Technology Co.,Ltd. Address: Room 102, Eastern building, No.166, South 1st Road, Development zone, Dongying, Shandong, China Phone Number: [phone] Contact: Kitty xu Date of Preparation: 2022.04.18

#### 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 Powder-Free Examination Gloves

Common name: Patient Examination Gloves

Classification name: Non-powdered patient examination glove

S, M, L, XL Model(s):

#### 3.0 Classification

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

#### 4.0 Predicate device information

Ever Global (Vietnam) Enterprise Corp Manufacturer:

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Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422

5.0 Indications For Use

The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

#### 6.0 Device description

The proposed device is Powder Free Disposable Nitrile Powder-Free 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 | Pending | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The Disposable Nitrile<br>Powder-Free Examination<br>Gloves 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. | 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 Powder-Free<br>Examination Gloves, | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, Disposable<br>Powder Free Nitrile<br>Examination Glove, | Same |

#### Table1-General Comparison

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| Non<br>******************************************************************************************************************************************************************************<br>راز الاستق | VIVIIV | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--|

| Predicate<br>Device(K171422) | Designation | Size | | | | Tolerance | |
|------------------------------|----------------|-----------|----------|----------|----------|-----------|----------|
| | Length, mm | XS<br>230 | S<br>230 | M<br>230 | L<br>230 | XL<br>230 | min |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| Proposed Device | Designation | Size | | | | Tolerance | |
| | Length, mm | | S<br>220 | M<br>230 | L<br>230 | XL<br>230 | min |
| | Width, mm | | 80 | 95 | 110 | 120 | $\pm 10$ |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | | min |
| Remark | Analysis 1 | | | | | | |

#### Table2 Device Dimensions Comparison

Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

| Item | | | Proposed device | Predicated device | Remark |
|------------------------|-----------------|------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------|-----------|
| Colorant | | | blue | White/ Blue/ Black/ Pink | Analysis2 |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa, min | 14MPa, min | SAME |
| | | Ultimate<br>Elongation | 500%min | 500%min | SAME |
| | After<br>Aging | Tensile<br>Strength | 14MPa, min | 14MPa, min | SAME |
| | | Ultimate<br>Elongation | 400%min | 400%min | SAME |
| Comply with ASTM D6319 | | | Comply with ASTM D6319 | Comply with ASTM D6319 | SAME |
| Freedom from Holes | | | Be free from holes when tested in accordance with<br>ASTMD5151<br>AQL=2.5 | Be free from holes when tested in accordance with<br>ASTMD5151 AQL=2.5 | SAME |
| Powder Content | | | 0.15-0.19 | Meet the requirements of<br>ASTM D6124 | SIMILAR |

#### Table3 Performance Comparison

Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect the safety of proposed device

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| Item | | Proposed device | Predicated device | Remark |
|----------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------|
| Material | | Nitrile | Nitrile | SAME |
| Biocompati<br>bility | Irritation | Under the conditions of the study,<br>not an irritant | Comply with<br>ISO10993-10 | SAME |
| | Sensitization | Under conditions of the study, not a<br>sensitizer. | | |
| | Cytotoxicity | Under the conditions of the study,<br>the device is potentially cytotoxic | Comply with<br>ISO10993-5 | Analysis3 |
| | Systemic<br>toxicity | Under the conditions of the study,<br>the device does not elicit a systemic<br>toxicity response in the model<br>animal. | Complies with ISO<br>10993-11 Third edition<br>2017-09 | |
| Label and Labeling | | Meet FDA's Requirement | Meet FDA'S<br>Requirement | SAME |

#### Table4 Safety Comparison

Analysis3: The proposed device is potentially cytotoxic, but all proposed devices are conducted the systemic toxicity test, the test results show that the proposed device is safe.

#### 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 | Skin Sensitization<br>Test:<br>provided<br>grades less than 1,<br>otherwise<br>sensitization. | All grades are 0.<br><br>All animals were survived and no<br>abnormal signs were observed<br>during the study. |
| 2 | | medical devices,<br>which may<br>produce skin and<br>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><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 17.1%<br><br>It means the proposed device<br>have potential toxicity to L-929 in<br>the MTT method |
| 4 | ISO 10993-11: 2017<br>Biological evaluation of<br>medical devices — Part<br>11: Tests for systemic<br>toxicity | To evaluate the<br>potential for<br>medical device<br>materials to cause<br>adverse systemic<br>reactions. | Within the monitoring<br>period (72 h), if the<br>toxicosis response of<br>testing group is not<br>greater than that of<br>control group, the<br>testing sample is<br>regarded as<br>acceptable. | There was no evidence of<br>systemic toxicity from the extract. |
| 5 | 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<br>filter-retained<br>mass) found<br>on medical gloves | powder residue limit of<br>2.0 mg | 0.15-0.19 mg /glove |
| 6 | ASTM<br>D5151-06(Reapproved2<br>015), Standard Test<br>Method for Detection of<br>Holes in 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<br>for water leakage | no glove water leakage found |
| | | | | |
| 7 | ASTM<br>D6319-10(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. | Sterility: no need<br>Freedom from holes:<br>pl. Refer to No. 5 in<br>table 5<br>Dimensions:<br>S: width 80±10mm<br>Length $\geq$ 220 mm<br>M: width 95±10mm<br>Length $\geq$ 230 mm<br>L: width 110±10mm<br>Length $\geq$ 230 mm<br>XL: width 120±10mm<br>Length $\geq$ 230 mm<br>Thickness:<br>Finger $\geq$ 0.05 mm<br>Palm $\geq$ 0.05 mm | N.A.<br>Please refer to No. 5 in table 5<br>Lot no.:210515<br>Dimensions:<br>S: width: 85-87 mm<br>Length 247-253 mm<br>M: width 88-96 mm<br>Length 242-257 mm<br>L: width 90-99 mm<br>Length 240-254 mm<br>XL: width 110-115 mm<br>Length 245-253 mm<br>Thickness:<br>Finger 0.09-0.21 mm<br>Palm 0.06-0.15 mm |
| | | | Physical properties:<br>Before aging<br>Tensile strength $\geq$<br>14MPa<br>Ultimate Elongation $\geq$<br>500%<br>After Accelerated<br>Aging<br>Tensile strength $\geq$<br>14MPa<br>Ultimate Elongation $\geq$<br>400%<br><br>Powder-free Residue:<br>pl. Refer to No. 4 in<br>table 5 | Physical properties:<br>Before aging<br>Tensile strength 14.1-22.5 MPa<br>Ultimate Elongation 503.274% -<br>670.613%<br>After Accelerated Aging<br>Tensile strength 14.6-20.8 MPa<br>Ultimate Elongation 411.403% -<br>592.683%<br><br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5<br>Lot no.:210518<br>Dimensions:<br>S: width: 84-86 mm<br>Length 248-256 mm<br>M: width 95-96 mm<br>Length 237-266 mm<br>L: width 105-108 mm<br>Length 257-262 mm<br>XL: width 114-117 mm<br>Length 252-262 mm<br>Thickness:<br>Finger 0.10-0.12mm<br>Palm 0.07-0.08mm |

## Table 5 Summary of Non-Clinical Performance Testing

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| | | Physical properties:<br>Before aging<br>Tensile strength 15.2-29.8 MPa<br>Ultimate Elongation 500.492% -<br>593.853%<br>After Accelerated Aging<br>Tensile strength 14.1-23.8MPa<br>Ultimate Elongation 451.751% -<br>597.368%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5<br>Lot no.:210520<br>Dimensions:<br>S: width: 84-87 mm<br>Length 244-257 mm<br>M: width 93-98 mm<br>Length 245-260 mm<br>L: width 104-110mm<br>Length 250-263 mm<br>XL: width 114-119 mm<br>Length 252-260 mm<br>Thickness:<br>Finger 0.10-0.12 mm<br>Palm 0.06-0.08 mm<br>Physical properties:<br>Before aging<br>Tensile strength 14.4-23.9MPa<br>Ultimate Elongation 501.484% -<br>547.660%<br>After Accelerated Aging<br>Tensile strength 14.2-23.9 MPa<br>Ultimate Elongation 492.901% -<br>599.996%<br>Powder-free Residue:<br>pl. Refer to No. 4 in table 5 |
|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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#### 9. Summary of Clinical Performance Test

No clinical study is included in this submission.

## 10.0 Conclusion

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.