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

K173017 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · LYZ · Dec 15, 2017 · General Hospital

Device Facts

• Record ID: K173017
• Device Name: Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
• Applicant: Anhui Kindguard Medical Supplies Technology Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for 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

Device consists of non-sterile, powder-free poly(vinyl chloride) (PVC) gloves. Acts as a physical barrier to prevent contamination between patient and examiner during medical procedures. PVC material is water-tight and conforms to the hand to allow necessary dexterity. Used in clinical settings by healthcare professionals. Output is the physical barrier provided by the glove. Benefits include protection against cross-contamination.

Clinical Evidence

No clinical data was used to demonstrate substantial equivalence. Evidence is based on bench testing, including physical property testing (tensile strength, elongation), water leak testing (pinholes), residual powder testing, and biocompatibility studies (primary skin irritation and dermal sensitization in accordance with ISO 10993-10).

Technological Characteristics

Material: Poly(vinyl chloride) (PVC). Standards: ASTM D5250-06 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residual), ISO 10993-10 (biocompatibility). Form factor: Disposable, non-sterile, powder-free, clear gloves. Sizes: Small, Medium, Large, X-large. Surface coating agent used for donning.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn by examiners 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 Glove (Non-colored) (K091663)

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.

December 15, 2017

Anhui Kindguard Medical Supplies 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, 100121 CN

Re: K173017

Trade/Device Name: Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 16, 2017 Received: September 27, 2017

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

### K173017

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 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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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# 510(K) Summary

"The assigned 510(k) number is: K173017 ..............................................................................................................................................................................

### Premarket Notification [510(k)] Summary

#### 1.0 Submitter:

| Submitter's name: | Anhui Kindguard Medical Supplies<br>Technology Co.,Ltd |
|-------------------------|--------------------------------------------------------------------------------------------------|
| Submitter's address: | Intersection of Yulan Road and Chaoyang Road, Sixian County, Suzhou City,<br>Anhui,234300, China |
| Phone number: | 0086-557-7606789 |
| Fax number: | 0086-557-7606789 |
| Name of contact person: | Chen Wei |
| Date of preparation: | 2017-09-16 |

#### 2.0 Name of th e Device

| Device Name: | Powder Free Vinyl Patient Examination<br>Gloves, Clear (non-colored) |
|-------------------------|--------------------------------------------------------------------------------|
| Proprietary/Trade name: | Kindguard Powder Free Vinyl Patient<br>Examination Gloves, Clear (non-colored) |
| CommonNam e | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Class ification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYZ |

### 3.0 Predicate device

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

### 4.0 Device Description:

#### 4.1 How the device functions:

PVC films form a barrier to prevent contamination between patient and examiner

#### 4.2 Scientific concepts that form the basis for the device

The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

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### 4.3 Physical and performance characteristics such as design, materials and physical properties:

The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

### 5.0 Device Intended Use (Indication for 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.

### 6.0 Summary of the Technological Characteristics of the Device:

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimension | ASTM D 5250-06(Reapproved 2011). |
| | Length ≥230mm |
| | Width Small 80-90 mm<br>Medium 90-100mm<br>Large 100-110mm<br>X large 110-120 mm |
| | Thickness Fingertip ≥0.05mm<br>Palm ≥0.08mm |
| | |
| | |
| Physical<br>Properties | ASTM D 5250-06(Reapproved 2011).<br>Tensile strength (Before & After aging) ≥11MPa<br>Elongated rate (Before & After aging) ≥300% |
| Freedom from<br>pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria<br>ASTM D5250-06(Reapproved 2011)<br>ASTM D5151-06(Reapproved 2011) |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011).and D6124-06(Reaffirmation 2011) Meets <2mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbits Passes<br>ISO 10993-10: 2010-08-01 Under the conditions<br>of the study, the<br>subject device is not a<br>primary skin irritant. |
| | Dermal sensitization in the guinea pig Passes<br>ISO 10993-10: 2010-08-01 Under the conditions<br>of the study, the<br>subject device is not a<br>skin sensitizer. |
| | |
| | |

### 7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 (Reapproved 2011), per ASTM D6124-06 Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10:2010-08-01.

The performance test data of the nonclinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

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## 8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:

Clinical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove. Determination of substantial equivalence is not based on an assessment of clinical performance data.

| Features & Description | | Predicate Device | Subject Device | Result of Comparison | | |
|-----------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------|------|
| Company | | Zhang Jia Gang<br>Fengyuan Plastic<br>Product Co.Ltd. | Anhui Kindguard<br>Medical Supplies<br>Technology Co.,Ltd | -- | | |
| 510(K) Number | | K091663 | | -- | | |
| 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 | | |
| Product Code | | LYZ | LYZ | Same | | |
| Size | | Small/ Medium/<br>Large/X large | Small/ Medium/<br>Large/X large | Same | | |
| Intend for use | | Powder free Vinyl<br>Patient Examination<br>Gloves,<br>Clear(Non-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<br>between patient and<br>examiner. | Powder free Vinyl<br>Patient Examination<br>Gloves, Clear<br>(Non-colored) is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. | Same | | |
| Device Description and<br>Specifications | | Meets ASTM<br>D5250-06 | Meets ASTM<br>D5250-06<br>(Reapproved 2011) | Same | | |
| Dimensions<br>Length<br>(mm)<br>ILS-2<br>AQL4.0 | | $\geq$ 230mm | 231-241mm | 232-241mm | Same | |
| | Dimensions<br>Width<br>(mm)<br>IL S-2<br>AQL4.0 | Small | 80-90 | 81-89 | 82-88 | Same |
| | | Medium | 90-100 | 93-99 | 93-98 | |
| | | Large | 100-110 | 102-110 | 102-108 | |
| | | X large | 110-120 | 111-1119 | 113-118 | |
| Dimensions<br>Thickness<br>(mm)<br>IL S-2<br>AQL4.0 | Finger | $\geq$ 0.05 | 0.05-0.10 | 0.08-0.11 | Same | |
| | Palm | $\geq$ 0.08 | 0.09-0.13 | 0.10-0.12 | | |
| Physical<br>Properties<br>ILS-2<br>AQL4.0 | | | Before aging/after aging | | Same | |
| | | Elongation | $\geq$ 300% | 340-410% | 350-420% | |
| | | Tensile Strength<br>> 14MPa | 15-25 MPa | 15-20 MPa | | |

### 9.0 Substantial Equivalence Comparison:

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| | Holes at<br>Inspection Level<br>IAQL2.5 | Holes at<br>Inspection Level I<br>AQL2.5 | Holes at<br>Inspection Level I<br>AQL2.5 | Same |
|------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Freedom from<br>Pinholes | | | | |
| Residual<br>Powder | below 2mg of<br>residual powder | 0.3mg | 0.1mg | Same |
| Materials used to fabricate<br>the devices | | PVC | PVC | Same |
| Dusting or Donning<br>Powder: name | | Surface Coating Agent | Surface Coating Agent | Same |
| Compare performance data<br>supporting substantial<br>equivalence | | Meets<br>ASTM D5151-06<br>(Reapproved 2011)<br>ASTM D5250-06<br>(Reapproved 2011)<br>ASTM D6124-06<br>(Reaffirmation 2011) | Meets<br>ASTM D5151-06<br>(Reapproved 2011)<br>ASTM D5250-06<br>(Reapproved 2011)<br>ASTM D6124-06<br>(Reaffirmation 2011) | Same |
| Single Patient Use | | Single Patient Use | Single Patient Use | Same |
| Biocompatibility | | Under the conditions<br>of this study, not an<br>irritant and Under the<br>conditions of this<br>study, not a sensitizer.<br><br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10:2002/Amd.1<br>:2006 | Under the conditions<br>of this study, not an<br>irritant and Under the<br>conditions of this<br>study, not a<br>sensitizer.<br><br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10 Third<br>Edition 2010-08-01 | Same |
| Labeling for the legally<br>marketed device to which<br>substantial equivalence is<br>claimed. | | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | -Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | Same |

#### Substantial Equivalence Comparison: 10.0

Discussion: The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL., meeting labeling claims.

The subject device The Powder Free Vinyl Patient Examination Gloves, Clear (noncolored) has the same intended use and technological and performance characteristics as the predicate device Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663, and therefore the devices are substantially equivalent.

Conclusion: The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663.