Powder-Free Latex examination gloves

K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · LYY · Nov 25, 2022 · General Hospital

Device Facts

• Record ID: K222612
• Device Name: Powder-Free Latex examination gloves
• Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, natural rubber latex examination gloves; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device provides a physical barrier; manufactured to meet ASTM D3578-19 specifications for physical properties, freedom from holes, and protein content. Available in multiple sizes (XS-XXL) and two length variants. Used in clinical settings; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only, including tensile properties, freedom from holes (ASTM D5151-19), residual powder (ASTM D6124-06), protein content (ASTM D5712-15), and biocompatibility (ISO 10993-10, ISO 10993-11).

Technological Characteristics

Material: Natural rubber latex. Standards: ASTM D3578-19 (physical properties), ASTM D5151-19 (holes), ASTM D6124-06 (powder), ASTM D5712-15 (protein). Biocompatibility: ISO 10993-10, ISO 10993-11. Form factor: Disposable, non-sterile, ambidextrous, various sizes/lengths. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

• Examination gloves-Type A (Latex gloves) (K214017)

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.

Guangdong Kingfa Sci.&Tech. Co., Ltd. % Xiaoge Yu Manager Guangdong Kingfa Sci.& Tech.Co., Ltd. No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China

Re: K222612

Trade/Device Name: Powder-Free Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 12, 2022 Received: August 30, 2022

### Dear Xiaoge Yu:

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.

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

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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 medical devices and radiation-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,

Digitally signed by Ramesh C. Ramesh C. Panquluri -S Panguluri -S Date: 2022.11.25 15:19:07 -05'00' For BiFeng Qian, M,D., 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K222612

Device Name Powder-Free Latex Examination Gloves

Indications for Use (Describe)

The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger 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) | <span style="text-decoration: underline;"> </span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="text-decoration: underline;">X</span> |

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# 510(k) Summary K222612

### I. Submitter

GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28, Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China Contact person: Xiaoge Yu Position: Manager Tel.: [phone] E-mail: [e-mail] Preparation date: November 21, 2022

### II. Proposed Device

| Device Trade Name | Powder-Free Latex Examination Gloves |
|--------------------|--------------------------------------|
| Common name: | Latex Patient Examination Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LYY |
| Review Panel | General Hospital |

#### III. Predicate Devices

| 510(k) Number: | K214017 |
|-----------------|-----------------------------------------------------------------|
| Trade name: | Examination gloves-Type A (Latex gloves) |
| Common name: | Latex Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LYY |
| Manufacturer: | Jiangxi Kemei Medical Apparatus & Instruments Group<br>Co., Ltd |

#### IV. Device description

The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.

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### V. Indication for use

The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.

### VI. Comparison of technological characteristics with the predicate devices

| Item | Proposed device | Predicate device<br>(K214017) | Discussion |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Powder-Free Latex Examination Gloves | Examination gloves-<br>Type A<br>(Latex gloves) | - |
| Product Code | LYY | LYY | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication for use | The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner. | The Examination gloves-Type A (Latex gloves) 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. | Similar |
| Main Material | Natural rubber latex | Natural rubber latex | Same |
| Color | Natural color | Natural White color | Similar |
| Size | X-Small, Small, Medium, Large, X-large, XX-large, | Small, Medium, Large | Similar |
| Palm width | X- Small(70±10mm)<br>Small (80±10mm)<br>Medium (95±10mm)<br>Large (110±10mm)<br>X-large (120±10mm) | Small (84-86mm)<br>Medium (96-98mm)<br>Large (105-108mm) | Similar |
| | XX-large (130±10mm) | | |
| Length | Short style<br>XS(220mm min)<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min)<br>XXL (230mm min)<br>Long style<br>XS~XXL(280mm min) | ≥230mm | Similar |
| Thickness | Palm: 0.05mm min<br>Finger: 0.08mm min | Palm: 0.11-0.13mm<br>Finger:0.13-0.14mm | Similar |
| Freedom from<br>holes | Meets requirements<br>of ASTM D3578-19 | Meets requirements<br>of the ASTM D3578-19 | Same |
| Physical<br>Properties<br>(before aging) | Meets requirements<br>of ASTM D3578-19 | Meets requirements<br>of ASTM D3578-19 | Same |
| Physical<br>Properties<br>(after aging) | Meets requirements<br>of ASTM D3578-19 | Meets requirements<br>of ASTM D3578-19 | Same |
| Powder<br>residue | Meets requirements<br>of ASTM D3578-19 | Meets requirements<br>of ASTM D3578-19 | Same |
| Protein Content | Meets requirements<br>of ASTM D3578-19 | Meets requirements<br>of ASTM D3578-19 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Shelf Life | - | 5 Years | Different |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | Confirm to the<br>requirements of ISO<br>10993 series<br>standards | Confirm to the<br>requirements of ISO<br>10993 series<br>standards | Same |

Table 1 Comparison of Latex examination gloves

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As above comparison, the differences in the dimensions of the subject and predicate device do not affect the safety and effectiveness of the device for its intended use. The biocompatibility test and performance test of the subject devices have been performed on the final finished device.

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### VII. Non-Clinical Testing

Non clinical tests were conducted in accordance with following standards to verify that the subject device (short and long variants) met all design specifications.

| Test | Purpose | Criteria | Result | |
|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------|------|
| ASTM D3578-19<br>Tensile properties | Demonstrate<br>adequate tensile<br>strength (unaged) | Greater than 18 MPa | Pass | |
| | Demonstrate<br>adequate elasticity<br>at 500% elongation<br>(unaged) | Stress less than 5.5 MPa | Pass | |
| | Demonstrate<br>adequate ultimate<br>elongation<br>(unaged) | Greater than 650% | Pass | |
| | Demonstrate<br>adequate tensile<br>strength after aging | Greater than 14 MPa | Pass | |
| | Demonstrate<br>adequate ultimate<br>elongation after<br>aging | Greater than 500% | Pass | |
| | ASTM D5151-19<br>Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves | Demonstrate glove<br>integrity | AQL 2.5 | Pass |
| ASTM D6124-<br>06(2017), Standard<br>Test Method for<br>Residual Powder on<br>Medical Gloves | | Demonstrate low<br>powder | Less than 2.0 mg/glove | Pass |
| ASTM D5712-15,<br>Standard Test<br>Method for Analysis<br>of Aqueous<br>Extractable Protein<br>in Natural Rubber | | Demonstrate low<br>level of extractable<br>protein | protein content not more<br>than 200 µg/ dm² | Pass |
| in Latex, Natural<br>Rubber, and<br>Elastomeric<br>Products Using the<br>Modified Lowry<br>Method | | | | |
| ISO 10993-10:<br>2010 Biological<br>Evaluation Of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And Skin<br>Sensitization. | Demonstrate low<br>potential for skin<br>irritation | Under the conditions of the<br>testing, not an irritant | Pass | |
| | Demonstrate low<br>potential for skin<br>sensitizer | Under the conditions of the<br>testing, not a sensitizer | Pass | |
| ISO 10993-<br>11:2017, Biological<br>evaluation of<br>medical devices –<br>Part 11:Tests for<br>Systemic Toxicity | Demonstrate low<br>acute systemic<br>toxicity | Under the conditions of the testing, no<br>acute systemic toxicity | Pass | |

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### VIII. Clinical Testing

No clinical study is included in this submission.

### IX. Conclusion

The conclusions drawn from the non-clinical testing demonstrate that the Powder-Free Latex Examination Gloves are as safe, as effective, and perform as well as or better than the predicate Examination gloves-Type A (Latex gloves) (K214017).