U-MED Powder Free Polyethylene Examination Gloves,Blue Color

K173228 · Jiangsu U-Med Rubber & Plastic Products Co., Ltd. · LZA · Feb 20, 2018 · General Hospital

Device Facts

• Record ID: K173228
• Device Name: U-MED Powder Free Polyethylene Examination Gloves,Blue Color
• Applicant: Jiangsu U-Med Rubber & Plastic Products Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Powder Free Polyethylene Examination Gloves,Blue Color 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

Non-sterile, disposable, low-density polyethylene examination gloves; blue color; available in sizes Small, Medium, Large, and X-Large. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings; worn by healthcare providers. Performance verified against ASTM D5250 and ASTM D5151 standards. Provides protection during medical examinations.

Clinical Evidence

No clinical data. Bench testing only, including dimensions, tensile strength, elongation, powder residual, water leak testing (ASTM D5151), and biocompatibility (ISO 10993-10).

Technological Characteristics

Material: Low Density Polyethylene. Form factor: Disposable glove. Standards: ASTM D5250-06 (Reapproved 2015), ASTM D5151-06 (Reapproved 2015), ASTM D6124-06 (Reaffirmation 2011), ISO 10993-10:2010-08-01. Tensile strength >11MPa; elongation >300%; powder residual <2mg/glove.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove 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

• C2 Powder Free Polyethylene Examination Glove (K113639)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring an abstract symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

February 20, 2018

Jiangsu U-MED Rubber & Plastic Products 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: K173228

Trade/Device Name: U-MED Powder Free Polyethylene Examination Gloves,Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: September 22, 2017 Received: November 22, 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

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801); medical device reporting of medical device-related 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.

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 mediation-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,

# 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K173228

Device Name

U-MED Powder Free Polyethylene Examination Gloves,Blue Color

Indications for Use (Describe)

Powder Free Polyethylene Examination Gloves,Blue Color 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) | <table style="border:none;"><tr><td><span style="padding-right:10px;">❍</span>Prescription Use (Part 21 CFR 801 Subpart D)</td><td><span style="padding-right:10px;">❌</span>Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="padding-right:10px;">❍</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right:10px;">❌</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="padding-right:10px;">❍</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right:10px;">❌</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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## 510(K) Summary

"The assigned 510(k) number is: _________K173228

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

#### Submitter: 1.0

| Submitter's name : | Jiangsu U-MED Rubber & Plastic Products<br>Co.,Ltd. |
|-------------------------|---------------------------------------------------------------------------------|
| Submitter's address : | Luzhuang Road,Suyu High-Tech Zone,Suqian<br>City,Jiangsu Province,223804,China. |
| Phone number : | 0086-512-81625988 |
| Fax number : | 0086-512-58455833 |
| Name of contact person: | Chen Ye |
| Date of preparation : | 2018-01-24 |

#### 2.0 Name of the Device

| Device Name: | U-MED Powder Free Polyethylene<br>Examination Gloves,Blue Color |
|------------------------|-----------------------------------------------------------------|
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |

### 3.0 Predicate device

| C2 Powder Free Polyethylene Examination Glove |
|-----------------------------------------------|
| AmerCare Inc. |
| K113639 |
| - |
| 21 CFR 880.6250 |
| LZA |
| |

### 4.0 Device Description:

The U-MED Powder Free Polyethylene Examination Gloves,Blue Color are nonsterile disposable Patient examination glove. The gloves are made of translucent (clear), Low Density Polyethylene material and are powder free. The U-MED Powder Free Polyethylene Examination Gloves,Blue Color come in four sizes: Small, Medium, Large, X Large.

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The Powder Free Polyethylene Examination Gloves, Blue Color acts as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the devices meets all requirements of ASTM D5250 and ASTM D5151.

### 5.0 Indication for use:

Powder Free Polyethylene Examination Gloves, Blue Color 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 Comparison table:

| Features & Description | Predicate Device | Subject Device | Result of<br>Comparison |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Company | AmerCare Inc. | Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. | -- |
| 510(K) Number | K113639 | K173228 | -- |
| Product name | Powder Free Polyethylene Examination Glove | U-MED Powder Free Polyethylene Examination Gloves,Blue Color | Similar |
| Product Code | LZA | LZA | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same |
| Indication for use | A powder-free ,no-sterile patient examination gloves is disposable device intended for ,medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Powder Free Polyethylene Examination Gloves,Blue Color 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. | Similar |
| Device Description and Specifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Dimensions:<br>Overall length, Width, Palm and Finger thickness | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Physical Properties<br>Tensile Strength before aging/after aging | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Ultimate Elongation before aging/after aging | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Freedom from Pinholes<br>Holes | Holes at Inspection Level I AQL2.5 | Holes at Inspection Level I AQL2.5 | Same |
| Residual Powder | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2015) | Same |
| Materials used to fabricate the devices | Polyethylene | Polyethylene | Same |

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| Color | Translucent [clear] | Blue color | Different |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Compare performance<br>data supporting<br>substantial 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 2015)<br>ASTM D5250-06<br>(Reapproved 2015)<br>ASTM D6124-06<br>(Reaffirmation 2011) | Same |
| Single Patient Use | Single Patient Use | Single Patient Use | Same |
| Biocompatibility | Under the conditions of<br>this study, not an irritant<br>and Under the conditions<br>of this study, not a<br>sensitizer.<br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10:2002/Amd.1:20<br>06 | Under the conditions of<br>this study, not an irritant<br>and Under the conditions<br>of this study, not a<br>sensitizer.<br>SKIN IRRITATION<br>DERMAL and<br>SENSITIZATION<br>STUDIES Meets ISO<br>10993-10 Third Edition<br>2010-08-01 | Same |
| Labeling for the legally<br>marketed device to<br>which substantial<br>equivalence is claimed. | There are no special<br>labeling claims and we do<br>not claim our gloves as<br>hypoallergenic on our<br>labels.<br>-Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | There are no special<br>labeling claims and we do<br>not claim our gloves as<br>hypoallergenic on our<br>labels.<br>-Powder Free<br>-Patient Examination<br>Glove<br>-Single Use Only<br>- Manufactured For:<br>- Lot | Same |

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

Powder Free Polyethylene Examination Gloves, Blue Color are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard |
|--------------------------|--------------------------------------------------------------------------------------------|
| | ASTM D 5250-06(Reapproved 2015). |
| Dimension | Length<br>$\ge$ 230mm |
| | Width |
| | Small 80-90 mm |
| | Medium 90-100mm |
| | Large 100-110mm |
| | X large 110-120 mm |
| | Thickness Fingertip $\ge$ 0.05mm<br>Palm $\ge$ 0.08mm |
| Physical<br>Properties | ASTM D 5250-06(Reapproved 2015). |
| | Tensile strength (Before & After aging) $\ge$ 11MPa |
| | Elongated rate (Before & After aging) $\ge$ 300% |
| Freedom from<br>pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria |
| | ASTM D5250-06(Reapproved 2015) |
| | ASTM D5151-06(Reapproved 2015) |
| Powder<br>Residual | ASTM standard D 5250-06(Reapproved 2015).and D6124-06(Reaffirmation 2011) Meets <2mg/glove |

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| Biocompatibility | Primary Skin Irritation in rabbits<br>ISO 10993-10: 2010-08-01 | Passes<br>Under the conditions of the<br>study, the subject device is not<br>a primary skin irritant. |
|------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | Dermal sensitization in the guinea pig<br>ISO 10993-10: 2010-08-01 | Passes<br>Under the conditions of the<br>study, the subject device is not<br>a skin sensitizer. |

#### 8.0 Non-Clinical Performance Data:

U-MED Powder Free Polyethylene Examination Gloves,Blue Color, meet requirements per ASTM D5250-06(Reapproved 2015), per ASTM D6124-06 Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10:2010-08-01.

Those verification tests of gloves were performed by qualified test centers according to the above standards and included dimensions, Tensile strength (Before & After aging) & Elongated rate (Before & After aging), powder residual, water leak testing, a n d biocompatibility.t. The overall results of the testing demonstrated that the subject glove passed testing performed according to ASTM D5250, Tensile strength (Before & After aging) was demonstrated more than 11MPa, Elongated rate (Before & After aging) was demonstrated more than 300%, powder residual was demonstrated less than 2 mg/device. The subject glove also did not raise any biocompatibility concerns when tested according to ISO 10993-5 and ISO 10993-10.The detail information for the non-clinical testing performed was shown on section 7.0 Summary of the Technological Characteristics of the Device.

#### Clinical Performance Data: 9.0

Clinical performance testing was not needed for this device.

#### 10.0 Conclusion:

Based on the nonclinical tests data, it can be concluded that the U-MED Powder Free Polyethylene Examination Gloves,Blue Color is as safe, as effective, and performs as well as the predicate device, C2 Powder Free Polyethylene Examination Glove AmerCare Inc. K113639.