Disposable Vinyl Examination Gloves

K203439 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · LYZ · Feb 26, 2021 · General Hospital

Device Facts

• Record ID: K203439
• Device Name: Disposable Vinyl Examination Gloves
• Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable vinyl examination gloves; non-sterile; ambidextrous; clear/non-colored. Used by clinicians to provide a protective barrier between patient and examiner to prevent cross-contamination. Device is worn on hands during medical examinations. Benefits include reduction of contamination risk. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ASTM D6124 (residual powder), ASTM D5151 (freedom from holes), ASTM D5250 (physical properties), ISO 10993-10 (irritation/sensitization), and ISO 10993-5 (cytotoxicity).

Technological Characteristics

Material: Vinyl. Design: Ambidextrous, non-sterile, clear/non-colored. Standards: ASTM D6124, ASTM D5151, ASTM D5250, ISO 10993-5, ISO 10993-10. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a protective barrier worn on the examiner's hands to prevent contamination between patient and examiner in medical 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

• Vinyl Patient Examination Gloves (White, Blue, Yellow) (K163168)

Submission Summary (Full Text)

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February 26, 2021

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

Re: K203439

Trade/Device Name: Disposable Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYZ Dated: November 5, 2020 Received: November 23, 2020

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 (OS) 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.

For Ryan Ortega, PhD 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) K203439

Device Name Disposable Vinyl Examination Gloves

Indications for Use (Describe)

The Disposable Vinyl Examination Gloves are 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 (K203439)

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

### 1.0 Submitter's Information

Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Phone Number: [phone] Contact: Junhui Zhu Date of Preparation: 03/11/2020

### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

# 2.0 Device information

Trade name: Disposable Vinyl Examination Gloves Common name: Non-powdered Patient Examination Glove Classification name: Vinyl Patient Examination Glove Model(s): XS, S, M, L, XL

# 3.0 Classification

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

# 4.0 Predicate device information

Manufacturer: Hebei Hongtai Plastic Products Company Limited Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168

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# 5.0 Indication for Use

The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.

# 6.0 Device description

The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

### 7.0 Technological Characteristics

| Item | Subject device | Predicated device | Comparison |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K203439 | K163168 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | / | / | Same |
| Intended Use | The Disposable Vinyl<br>Examination Gloves are a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hands to<br>prevent contamination<br>between patient and<br>examiner. | The Vinyl Examination<br>Glove (White, Blue, or<br>Yellow) is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hands to<br>prevent contamination<br>between patient and<br>examiner. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single use, powder free,<br>device color, device<br>name, glove size and<br>quantity, Vinyl<br>Examination Gloves,<br>Non-Sterile | Single use, powder<br>free, device color,<br>device name, glove size<br>and quantity, Vinyl<br>Examination Gloves,<br>Non-Sterile | Similar |
| Sterility | Non-Sterile | Non-Sterile | Same |

#### Table1-General Comparison

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| Predicate | Designation | Size | | | | Tolerance | |
|-----------------|----------------|------|-----|-----|-----|-----------|-----|
| Device(K163168) | | XS | S | M | L | XL | |
| | Length, mm | 230 | 230 | 235 | 245 | 245 | min |
| | Width, mm | 80 | 85 | 95 | 105 | 115 | ±5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | min | |
| | Palm | 0.08 | | | | min | |
| Subject Device | Designation | Size | | | | Tolerance | |
| | | XS | S | M | L | XL | |
| | Length, mm | 220 | 220 | 230 | 230 | 230 | min |
| | Width, mm | 70 | 80 | 90 | 100 | 110 | ±5 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.05 | | | | min | |
| | Palm | 0.08 | | | | min | |
| Remark | SAME | | | | | | |

# Table2 Device Dimensions Comparison

#### Table3 Performance Comparison

| Item | Subject device | Predicated device | Comparison | | |
|------------------------|--------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------|-----------|
| Colorant | Clear, Non-Colored | White, Blue, Yellow | Analysis1 | | |
| Physical<br>Properties | Before<br>Aging | Tensile Strength | 11MPa, min | 15MPa, min | Analysis2 |
| | | Ultimate Elongation | 300%min | 380%min | Analysis2 |
| | After<br>Aging | Tensile Strength | 11MPa, min | 15MPa, min | Analysis2 |
| | | Ultimate Elongation | 300%min | 380%min | Analysis2 |
| | | Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 | SAME |
| Freedom from Holes | | Be free from holes when<br>tested in accordance with<br>ASTM D5151 AQL=2.5 | Be free from holes when<br>tested in accordance with<br>ASTM D5151 AQL=2.5 | SAME | |
| Powder Content | | <0.04 mg per glove.<br>Meets the requirements of<br>ASTM D6124 | Meet the requirements of<br>ASTM D6124 | SIMILAR | |

Analysis1: The subject device (colorless) has different color to the predicate device (White, Blue, Yellow), but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not affect the safety of proposed device.

Analysis2: The tensile strength and ultimate elongation are different with that of the predicate, but they all meet the requirements of ASTM D5250, so the differences do not raise any new safety or performance questions.

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| Item | | Subject device | Predicated device | Comparison |
|--------------------|---------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|------------|
| Material | | Vinyl | Vinyl | SAME |
| Biocompatibility | Irritation | Under the conditions of the<br>study, not an irritant.<br>Complies with ISO 10993-10 | Comply with<br>ISO10993-10 | SAME |
| | Sensitization | Under conditions of the<br>study, not a sensitizer.<br>Complies with ISO 10993-10 | | SAME |
| | Cytotoxicity | Under conditions of the<br>study, did not show potential<br>toxicity to L-929 cells.<br>Complies with ISO 10993-5 | / | Different |
| Label and Labeling | | Meet FDA's Requirement | Meet FDA's<br>Requirement | SAME |

### Table4 Safety Comparison

# 8.0 Discussion of non-clinical and clinical test performed

Non-clinical tests were conducted to verify that the proposed device met all design specifications. 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

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

ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D5250-06, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

Clinical testing is not needed for this device.

#### 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 or better than the legally marketed predicated device.