Latex Examination Gloves, Powder Free

K213509 · Shandong Intco Medical Products Co, Ltd. · LYY · Apr 8, 2022 · General Hospital

Device Facts

• Record ID: K213509
• Device Name: Latex Examination Gloves, Powder Free
• Applicant: Shandong Intco Medical Products Co, Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Apr 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable patient examination glove; worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings; intended for over-the-counter use. Device provides protection during medical examinations; benefits patient and examiner by reducing risk of contamination.

Clinical Evidence

Bench testing only. Device complied with ASTM D3578-19 (physical properties), ASTM D5151-06 (freedom from holes), ASTM D6124-06 (residual powder), and ISO 10993-10:2010 (irritation and sensitization). No clinical data provided.

Technological Characteristics

Material: Natural rubber latex. Form factor: Powder-free examination glove. Standards: ASTM D3578-19, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010. Non-sterile. No color pigment added (natural white).

Indications for Use

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

• Careglove Global SDN BHD (K161833)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

April 8, 2022

Shandong Intco Medical Products Co, Ltd. % John Zhao Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave. Ontario, California 91764

Re: K213509

Trade/Device Name: Latex Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: March 8, 2022 Received: March 9, 2022

Dear John Zhao:

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

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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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213509

Device Name Powder Free Latex Examination Glove

Indications for Use (Describe)

A 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.

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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Image /page/3/Picture/0 description: The image shows the logo for Shandong Intco Medical Products Co., Ltd. The logo includes a stylized blue graphic to the left of the company name. Below the company name is the address: 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, 262500.

510(K) SUMMARY

### 1. Submitter's Identification:

Shandong Intco Medical Products Co, Itd. 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, 262500 China

#### Contact Person :

Haisheng Yu Vice General Manager

#### Date summary prepared: Oct. 28, 2021

- 2. Product Trade Name: Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free
- 3. Device Classification Name: Patient Examination gloves (21 CFR 880.6250)
- Device Class: 4. Class I.
- Product Code: 5. LYY
- Predicate Devices: 6. K161833 – Careglove Global SDN BHD

# 7. Reason for 510(k) Submission:

New device.

#### 8. Device Description:

Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

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# 9. Intended Use:

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

## 10. Technology Characteristic Comparison between the device and predicate device:

There is no difference in technology characteristic compared to the predicate device. Gloves are made from natural rubber latex compound. Non-Sterile, Powder Free Latex Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.

| Characteristics<br>and Parameters | Powder Free<br>Latex<br>Examination<br>Glove | Powder Free<br>Latex<br>Examination<br>Glove (K161833) | Comparison |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | LYY | LYY | Same |
| Intended Use | A patient<br>examination glove<br>is a disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the hand<br>or finger to<br>prevent<br>contamination<br>between patient<br>and examiner. | A patient<br>examination glove<br>is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>hand or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. | Same |
| Classification | Class I | Class I | Same |
| Raw Rubber<br>Material | Natural Rubber<br>Latex | Natural RubberLatex | Same |
| Color | No color pigment<br>added. Natural<br>White | No color pigment<br>added.Natural<br>White | Similar |
| Overall Length<br>Minimum230mm | Average: 247 mm | Meet ASTM D3578-<br>05 | Similar |
| Width<br>S: 75mm - 95mm; M: 85mm –<br>105mm; L:100mm- 120mm | Average:<br>S: 85mm<br>M:96 mm<br>L:104 mm: | S: 82mm - 87 mm M:<br>94mm - 97mm L: 102mm -<br>107mm | Similar |
| Palm Thickness (Minimum | Average: 0.122 mm | 0.12mm - 0.14 mm | Similar |
| 0.08mm) | | | |
| Finger Thickness (Minimum | Average:0.156 mm | 0.10 - 0.13 mm | Similar |
| 0.08mm) | | | |
| Tensile Strength (before age)<br>Minimum 18 MPa | Average: 26.17MPa | 21.18 - 26.17 MPa | Similar |
| Tensile Strength (After Age)<br>Minimum 14 MPa | Average: 24.82MPa | 18.28 - 23.88 MPa | Similar |
| Stress at 500% Elongation 5.5 MPa<br>Maximum | 4.99 MPa | 3.0 - 4.2 MPa | Similar |
| Ultimate Elongation before age<br>(Minimum 500%) | Average: 759.85% | 750.20% - 820.20% | Similar |
| Ultimate Elongation after age<br>(Minimum 400%) | Average: 678.62% | 550.40% - 700.50% | Similar |
| Freedom of Holes<br>Meet AQL 2.5 at G1 | Meet AQL 2.5 with G1 | Meet AQL 2.5 with G1. | Similar |
| Residual powder test | Average powder<br>residue for each<br>size: | Contained less than 2 mg/glove | Similar |
| (Less than 2mg/glove) | S: 0.43 mg/glove;<br>M 0.31 mg/glove;<br>L: 0.47 mg/glove | | |
| Protein Testing | S size: Less than 50<br>µg/dm2; M size: Less<br>than 50 µg/dm2; L size:<br>Less than 50 µg/dm2 | less than 50 µg/dm2 | Similar |
| Primary Skin Irritation | Under the conditions of<br>study, not an irritant | Under the conditions of study,<br>not an irritant | Same |
| Dermal Sensitization | Under the conditions<br>of study, not a sensitizer. | Under the conditions of study,<br>not a sensitizer. | Same |
| Acute Systemic Toxicity | Under the conditions of<br>the study, no evidence<br>of systemic toxicity<br>from the extract | Not available | Different |

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# 11. Non-clinical Testing Summary:

Provided below is a summary of the standards and the test methodology that the subject device met the specification and acceptance criteria of the subject device.

| Test Methodology | Purpose | Acceptance Criteria | Result |
|----------------------------------------------------------|----------------------------------------------------------------------|---------------------|-------------------------------|
| Biological Evaluation<br>of Medical Devices -<br>Part 10 | Tests For Irritation And<br>Skin Sensitization. | ISO 10993-10:2010 | Complied with the<br>standard |
| ASTM D6124-06<br>(Reapproved 2017) | Standard Test Method for<br>Residual Powder on<br>Medical Gloves | ASTM D6124-06 | Complied with the<br>standard |
| ASTM D5151-<br>06(Reapproved2015) | Standard Test Method for<br>Detection of Holes in<br>Medical Gloves. | ASTM D5151-06 | Complied with the<br>standard |
| ASTM D3578 - 19 | Standard Specification for<br>Rubber Examination<br>Gloves | ASTM D3578 - 19 | Complied with the<br>standard |

# 12. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that Shandong Intco Medical Products Co., Ltd. Powder Free, Latex Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device.