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

K162259 · Zibo Daiyang Plastic Company · LYZ · Dec 21, 2016 · General Hospital

Device Facts

• Record ID: K162259
• Device Name: DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
• Applicant: Zibo Daiyang Plastic Company
• Product Code: LYZ · General Hospital
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

DAIYANG 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, disposable PVC patient examination gloves. Function: acts as physical barrier to prevent contamination between patient and examiner. Operation: PVC film provides water-tight barrier; material tensile properties allow hand/finger movement during medical procedures. Used in clinical settings by healthcare professionals. Output: physical protection for examiner and patient. Benefit: reduces risk of cross-contamination during examinations.

Clinical Evidence

Bench testing only. No clinical data was required. Testing included physical dimensions, tensile strength, elongation, pinhole leak rates (AQL 2.5), residual powder levels, and biocompatibility (ISO 10993-10 skin irritation and dermal sensitization).

Technological Characteristics

Material: Poly (vinyl chloride) (PVC). Form factor: Disposable, non-sterile, clear gloves. Standards: ASTM D5250-06 (dimensions/physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder residual). Biocompatibility: ISO 10993-10:2010. Sensing/Actuation: None (passive barrier).

Indications for Use

Indicated for use as a non-sterile, disposable medical glove worn by examiners on hands or fingers 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2016

Zibo Daiyang Plastic Company % Chu Xiaoan Official Correspondent Beijing Easylink Co., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Beijing, CN 100121

Re: K162259

Trade/Device Name: DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 8, 2016 Received: November 22, 2016

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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

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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# Indications for Use

510(k) Number (if known) K162259

Device Name

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

Indications for Use (Describe)

DAIYANG 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.

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

The assigned 510(k) number is:______K162259

# Premarket Notification [510(k)] Summary

#### 1.0 Submitter:

| Submitter's name : | Zibo Daiyang Plastic Company |
|-------------------------|---------------------------------------------------------------------------------------|
| Submitter's address : | North of Shiji Rd,Zhuangyuan Industrial Park,<br>Zhangdian,Zibo,Shandong,255087,China |
| Phone number : | 0086-533-3813666 |
| Fax number : | 0086-533-3811696 |
| Name of contact person: | Yang Yan Hong |
| Date of preparation : | 2016-12-16 |

#### 2.0 Name of the Device

| Device Name: | Powder Free Vinyl Patient Examination<br>Gloves, Clear (non-colored) |
|-------------------------|------------------------------------------------------------------------------|
| Proprietary/Trade name: | DAIYANG Powder Free Vinyl Patient<br>Examination Gloves, Clear (non-colored) |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | 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. It's 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):

DAIYANG 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<br>Small 80-90 mm<br>Medium 90-100mm<br>Large 100-110mm<br>X large 110-120 mm |
| | Thickness Fingertip ≥0.05mm |
| | 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 Not a Primary Skin Irritation |
| | Dermal sensitization in the guinea pig Passes<br>ISO 10993-10: 2010-08-01 Not a Dermal sensitization |

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

DAIYANG 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.

| Features & Description | Predicate Device | Subject Device | Result<br>of<br>Comparison | | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------|
| Company | Zhang Jia Gang<br>Fengyuan Plastic<br>Product Co.Ltd. | Zibo Daiyang Plastic<br>Company | -- | | |
| 510(K) Number | K091663 | K162259 | -- | | |
| 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<br>a 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. | DAIYANG Powder<br>free Vinyl<br>Patient Examination<br>Gloves, Clear<br>(non-colored) is a<br>non-sterile 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<br>between patient and | Similar | | |
| Device Description and<br>Specifications | Meets ASTM<br>D5250-06 | Meets ASTM<br>D5250-06<br>(Reapproved 2011) | Similar | | |
| Dimensions<br>Length (mm)<br>ILS-2<br>AQL4.0 | ≥230mm | 231-241mm | 232-240mm | Similar | |
| Dimensions<br>Width (mm)<br>IL S-2<br>AQL4.0 | Small 80-90<br>Medium 90-100<br>Large 00-110<br>X large 110-120 | 81-89<br>93-99<br>102-110<br>111-1119 | 81-87<br>93-98<br>102-109<br>113-118 | Similar | |
| Dimensions<br>Thickness<br>(mm)<br>IL S-2<br>AQL4.0 | Finger ≥0.05<br>Palm ≥0.08 | 0.05-0.10<br>0.09-0.13 | 0.08-0.11<br>0.10-0.12 | Similar | |
| Physical<br>Properties<br>IL S-2<br>AQL4.0 | Before aging/after aging<br>Elongation ≥300%<br>Tensile Strength<br>≥ 14MPa | | 340-410%<br>15-25 MPa | 350-420%<br>15-20 MPa | Similar |
| Freedom<br>from Pinholes | Holes at<br>Inspection Level<br>I AQL2.5 | | Holes at<br>Inspection Level I<br>AQL2.5 | Holes at<br>Inspection Level I<br>AQL2.5 | Similar |
| Residual<br>Powder | below 2mg of<br>residual powder | 0.3mg | 0.1mg | Similar | |
| Materials used to fabricate the<br>devices | | PVC | PVC | Similar | |
| Dusting or Donning Powder:<br>name | | Surface Coating<br>Agent | Surface Coating<br>Agent | Similar | |
| 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) | Similar | |
| Single Patient Use | | Single Patient Use | Single Patient Use | Similar | |
| Biocompatibility | | 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>10993-10:2002/Amd.<br>1:2006 | 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 | Similar | |
| Labeling for the legally marketed<br>device to which substantial<br>equivalence is 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 | Similar | |

# 9.0 Substantial Equivalence Comparison:

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#### 10.0 Substantial Equivalence Comparison:

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

The subject device The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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: Based on the nonclinical tests data, it can be concluded that 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.