Medical Examination Gloves

K212311 · Guangzhou Junda Gloves Co., Ltd. · LZA · Oct 21, 2021 · General Hospital

Device Facts

• Record ID: K212311
• Device Name: Medical Examination Gloves
• Applicant: Guangzhou Junda Gloves Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; blue color; worn by healthcare providers during medical examinations or diagnostic/therapeutic procedures to provide a barrier against contamination. Device functions as a physical barrier; no active components or software. Manufactured to meet ASTM D6319, ASTM D5151, and ASTM D6124 standards. Used in clinical settings; intended for single-use.

Clinical Evidence

Bench testing only. Compliance with ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), ASTM D6124 (residual powder), ASTM D5151 (hole detection), and ASTM D6319 (physical properties/dimensions). Cytotoxicity testing showed 38.4% viability, but systemic toxicity testing confirmed the device is safe for use.

Technological Characteristics

Nitrile rubber material; non-sterile; ambidextrous; blue color. Complies with ASTM D6319, ASTM D5151, and ASTM D6124. Dimensions vary by size (S, M, L, XL) with finger/palm thickness ≥0.05 mm. No energy source, software, or connectivity.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hands or fingers to prevent 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

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

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 21, 2021

Guangzhou Junda Gloves Co., Ltd Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K212311

Trade/Device Name: 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: July 20, 2021 Received: July 23, 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Clarence W. Murray, III, Ph.D. 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) K212311

Device Name Medical Examination Gloves

Indications for Use (Describe)

The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or finger 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 - K212311

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: Guangzhou Junda Gloves Co., Ltd Address: No.38 Heting Fengwei Industrial Zone Renhe Town Baiyun District, Guangzhou,Guangdong,510470,China Phone Number: [phone] Contact: Olivia Chen Date of Preparation: 2021.07.20

#### Designated Submission Correspondent

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

#### 2.0 Device information

Trade name: Medical Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

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

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## 5.0 Intended use

The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

## 6.0 Device description

The proposed device is Powder Free Medical 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 | K212311 | K171422 | |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Medical Examination<br>Gloves is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands or finger to prevent<br>contamination between<br>patient and examiner | The Nitrile Powder Free<br>patient examination glove<br>is a non-sterile disposable<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hands or finger 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, Medical<br>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

#### Table2 Device Dimensions Comparison

| Predicate | Designation | Size | Tolerance |
|-----------|-------------|------|-----------|
|-----------|-------------|------|-----------|

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| Device(K171422) | | XS | ട | M | L | XL | |
|-----------------|----------------------------------|------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------|-----|
| | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width, mm | 75 | 85 | ત્ત્વની તે જેવાયું છે છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલ | 105 | 115 | – 5 |
| | Thickness, mm:<br>Finger<br>0.05 | | | | | | |
| | | | | | | min | |
| | Palm | 0.05 | | | | min | |
| Proposed Device | Designation | Size | | | | Tolerance | |
| | | ട | | M | L | XL | |
| | Length, mm | 220 | | 230 | 230 | 230 | min |
| | Width, mm | 80 | | ત્ત્વની તે જેવાયું છે છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલ | 110 | 120 | +10 |
| | | | | Thickness, mm: | | | |
| | Finger | 0.05 | | | | | min |
| | Palm | 0.05 | | | | min | |
| Remark | Analysis1 | | | | | | |

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.

| Table3 Performance Comparison | |
|-------------------------------|--|
| | |

| 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<br>when tested in<br>accordance with<br>ASTMD5151<br>AQL=2.5 | Be free from holes when<br>tested in accordance with<br>ASTMD5151 AQL=2.5 | SAME |
| Powder Content | | | | 0.11 | Meet the requirements of<br>ASTM D6124 | SIMILAR |

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 Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications and acceptance criteria. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19,Standard Specification For Nitrile Patient Examination Gloves For Medical Application.

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

| No. | Name of the Test | Purpose | Acceptance Criteria | Results |
|-----|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Methodology / Standard | | | |
| 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 10993 assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test:<br>provided grades less than 1, otherwise sensitization. | All grades are 0.<br>All animals were survived and no abnormal signs were observed during the study. |
| 2 | | | Skin Irritation Test:<br>If the primary irritation index is 0-0.4, the response category is 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 device was categorized as negligible under the test 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 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 38.4%<br>It means the proposed device have potential toxicity to L-929 in the MTT method |
| 4 | ISO 10993-11: 2017<br>Biological evaluation of medical devices — Part<br>11: Tests for systemic toxicity | To evaluate the potential for medical device materials to cause adverse systemic reactions. | Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable. | No toxicosis response in testing group.<br>It means the test article has no potential acute system toxicity on ICR mice in the extraction method. |
| 5 | ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | This standard is designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves | powder residue limit of 2.0 mg | 0.11 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>Dimensions:<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 ≥230 mm<br>XL: width 120±10mm<br>Length ≥230 mm<br>Thickness:<br>Finger ≥0.05 mm<br>Palm ≥0.05 mm | N.A.<br>Dimensions:<br>S: width: 84-87 mm<br>Length 239-242 mm<br>M: width 95-97 mm<br>Length 243-245 mm<br>L: width 104-106 mm<br>Length 250-252 mm<br>XL: width 114-117 mm<br>Length 244-247 mm<br>Thickness:<br>Finger 0.09 mm<br>Palm 0.07 mm |
| | | | 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>Powder-free Residue:<br>pl. Refer to No. 4 in<br>table 5 | Physical properties:<br>Before aging<br>Tensile strength 14.06-20.59<br>MPa<br>Ultimate Elongation 552.680% -<br>652.080%<br>After Accelerated Aging<br>Tensile strength 14.06-16.90MPa<br>Ultimate Elongation 508.43% -<br>646.33%<br>Powder-free Residue:<br>pl. Refer to No. 5 in table 5 |

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# 9.0 Conclusion

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