Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K191292 · Anhui Powerguard Technology Co., Ltd. · LYZ · Nov 5, 2019 · General Hospital

Device Facts

• Record ID: K191292
• Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
• Applicant: Anhui Powerguard Technology Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 vinyl 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 by healthcare providers. Device is non-sterile, clear, and powder-free. Provides protection during patient examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D5250-06 (dimensions, physical properties), ASTM D5151-06 (pinholes), and ASTM D6124-06 (residual powder). Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization) and ISO 10993-5 (cytotoxicity).

Technological Characteristics

Material: PVC. Form factor: Disposable, non-sterile, powder-free glove. Dimensions: Length ≥233mm, thickness 0.08-0.11mm (finger/palm). Standards: ASTM D5250-06 (Reapproved 2011), ASTM D5151-06, ASTM D6124-06, ISO 10993-5, ISO 10993-10. No software or electronic components.

Indications for Use

Indicated for use as a disposable, non-sterile 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

• Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K091663)

Submission Summary (Full Text)

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November 5, 2019

Anhui Powerguard Technology Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easylink CO., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju Courtyard 6 of Southern Dou Ge Zhuang Beijing, 100021 Cn

Re: K191292

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: September 27, 2019 Received: October 7, 2019

Dear Chu Xiaoan:

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 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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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)

K191292

Device Name

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Indications for Use (Describe)

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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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# 510(K) Summary

# K191292

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

#### 1.0 Submitter:

| Submitter's name: | Anhui Powerguard Technology Co.,Ltd |
|-------------------------|-------------------------------------------------------------------------------------|
| Submitter's address: | North Development Zone, Lingbi County,<br>Suzhou City, Anhui Province,234200, China |
| Name of contact person: | Mr. Nike Dai |
| Date of preparation: | 2019-11-05 |

### Designated Submission Correspondent

| Company's name | Beijing Easy-Link Company |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Company's address | Rm. F302 Bldg., 41, Jing Cheng Ya Ju,<br>Courtyard 6 of Southern Dou Ge Zhuang,<br>Chaoyang District, Beijing 100121, P.R.<br>China |
| Contact person | Chu Xiaoan |
| Name of the Device | |

#### Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Proprietary/Trade name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Common Name: Exam gloves Classification Name: Patient examination glove Device I Regulation Number: 21 CFR 880.6250 Panel: General Hospital LYZ Product Code:

#### 3.0 Predicate device

2.0

| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear<br>(non-colored) |
|----------------|----------------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663 |

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# 4.0 Device Description:

The proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.

### 5.0 Indications for Use Statement:

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

# 6.0 Technological Characteristic Comparison Table:

| Features &<br>Description | Predicate Device<br>(K091663) | Subject Device<br>(K191292) | Comparison |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Powder Free Vinyl<br>Patient Examination<br>Gloves, Clear<br>(non-colored) | Powder Free Vinyl<br>Patient Examination<br>Gloves, Clear<br>(non-colored) | Same |
| Regulation<br>Number | 21CFR880.6250 | 21CFR880.6250 | same |
| Product Code | LYZ | LYZ | same |
| Color | Clear(non-colored) | Clear(non-colored) | same |
| Size | Small/ Medium/<br>Large/X large | Small/ Medium/<br>Large/X large | same |
| Indications for<br>Use | Powder Free Vinyl<br>Patient Examination<br>Gloves, Clear (non-<br>colored) is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. | Powder Free Vinyl<br>Patient Examination<br>Gloves, Clear (non-<br>colored) is a disposable<br>device intended for<br>medical purposes that<br>is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | same |
| Device<br>Description and<br>Specifications | Meets ASTM D5250-<br>06 | Meets ASTM D5250-<br>06(Reapproved 2011) | Same |
| Dimensions --<br>Length<br>ILS-2<br>AQL4.0 | Meets ASTM D5250-<br>06<br>$\geq$ 230mm min | 233 mm min for all<br>sizes | Similar |
| Dimensions -- Width<br>IL S-2<br>AQL4.0<br>(mm) | Meets ASTM D5250-<br>06<br>Small 80-90<br>Medium 90-100<br>Large 100-110<br>X large 110-120 | Small 84-88<br>Medium 94-98<br>Large 103-109<br>X large 114-117 | Similar |

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| Dimensions | | | Similar |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| --Thickness<br>IL S-2<br>AQL4.0 | Meets ASTM D5250-06<br>Finger 0.05mm min.<br>Palm 0.05mm min. | Thickness (mm) min.<br>Finger 0.08<br>Palm 0.10 | |
| Physical<br>Properties<br>IL S-2<br>AQL4.0 | Meets ASTM D5250-06<br>Before aging/after aging<br>Tensile Strength≥<br>11MPa<br>Elongation ≥300% | 15-17 MPa<br>350-390% | Similar |
| Freedom from<br>Pinholes<br>Inspection Level<br>I AQL2.5 | Meets<br>• 21 CFR 800.20<br>• ASTM D6319-10 | 1) Inspection Level I<br>AQL2.5,and<br>Accept/Reject<br>criteria of 10/11<br>2) Water leakage test:<br>3 noncompliance<br>is allowed. | similar |
| Residual<br>Powder | Meets ASTM<br>D 6124-06<br>(Reaffirmation 2011)<br>below 2mg of residual<br>powder | 1) Checked on 5pcs<br>sub-samples<br>(N=5).<br>2) Result as<br>following:<br>Mean: 0.1mg/pcs | similar |
| Materials used<br>to fabricate the<br>devices | PVC | PVC | same |
| Single Patient<br>Use | Single Patient Use | Single Patient Use | same |
| Biocompatibility | Under the conditions<br>of this study, the test<br>article was a non-<br>irritant or non-<br>sensitizer | Under the conditions<br>of this study, the test<br>article was a non-<br>irritant or non-<br>sensitizer<br>Under the conditions<br>of this study, the test<br>article was non-<br>cytotoxicity to L-929<br>cells. | similar |
| Labeling for the<br>legally marketed<br>device to which<br>substantial<br>equivalence is<br>claimed. | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>- Clear(non-colored)<br>- Non sterile | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot<br>- Clear(non-colored)<br>- Non sterile | same |

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## 7.0 Discussion of Non-clinical Testing

Non-clinical tests were conducted to verify that the proposed device will meet acceptance crtiteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:

| Name of Test | Purpose | Acceptance Criteria | Result | |
|--------------|----------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Dimension | Meet<br>ASTM D 5250-<br>06(Reapproved 2011). | Length | ≥230mm | 233-241mm |
| | | Width | Small 80-90 mm<br>Medium 90-100mm<br>Large 100-110mm<br>X large 110-120 mm | 84-88 mm<br>94-98 mm<br>103-109 mm<br>114-117 mm |
| | | Thickness | Fingertip ≥0.05mm<br>Palm ≥0.08mm | 0.08-0.11mm<br>0.10-0.11mm |
| | Physical<br>Properties | Meet<br>ASTM D 5250-<br>06(Reapproved 2011). | (Before & After aging)<br>Tensile strength ≥11MPa<br>Elongated rate ≥300% | |
| | Freedom from<br>pinholes | Meet<br>ASTM D5151-06<br>(Reapproved 2011) | Holes at Inspection Level I<br>AQL2.5<br>Act/Re:10/11 | |
| | Powder Residual | Meet<br>ASTM D6124-06<br>(Reaffirmation 2011) | <2mg/glove | |
| | Biocompatibility | Meet<br>ISO 10993-10: 2010-<br>08-01 | Primary Skin Irritation in rabbits | |
| | Meet<br>ISO 10993-10: 2010-<br>08-01 | Dermal sensitization in the guinea<br>pigs | | Passes<br>Under the conditions of<br>the study, the subject<br>device is not a skin<br>sensitizer. |
| | Meet<br>ISO 10993-5: 2009 | The test article was added to L929<br>cells measured by MTT assay | | Pass<br>Under the conditions of<br>this study, the test<br>article was non-<br>cytotoxicity to L-929<br>cells |

# 8.0 Discussion of Clinical and Performance Testing

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.