VINYL EXAMINATION POWDER FREE GLOVES, CLEAR

K123590 · Weilin Plastic and Rubber Products Co., Ltd. · LYZ · Jun 17, 2013 · General Hospital

Device Facts

• Record ID: K123590
• Device Name: VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
• Applicant: Weilin Plastic and Rubber Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body. fluids, waste or environment.

Device Story

Disposable vinyl patient examination glove; worn by healthcare personnel to prevent cross-contamination between examiner and patient/environment. Device consists of poly vinyl chloride, polyurethane, and diisononyl phthalate (DINP). Used in clinical settings; provides barrier protection. Output is physical barrier; affects clinical decision-making by maintaining sterile/clean field during examinations. Benefits patient by reducing risk of infection transmission.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D5250-06 standards, including tensile strength, ultimate elongation, pinhole testing (AQL 2.5), and residual powder content (< 2 mg/glove). Biocompatibility confirmed via ISO 10993-10 for primary skin irritation and sensitization.

Technological Characteristics

Materials: Poly vinyl chloride, polyurethane, diisononyl phthalate (DINP). Standards: ASTM D5250-06, ASTM D6124-06, ASTM D5151-06. Dimensions: ~230mm length, 95mm palm width, 0.073mm palm thickness, 0.090mm finger thickness. Energy source: None (manual). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use as a disposable medical glove worn on the hands or fingers of healthcare personnel to prevent cross-contamination between the patient and the 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

• Shiiiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)

Submission Summary (Full Text)

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K123590

## 510 (K) SUMMARY

# JUN 1 7 2013

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.

#### Submitter's Identification: 1.

Weilin Plastic and Rubber Products Co., Ltd. 601 Jiangjunsan Road Qingzhou, Shandong, China

Date summary prepared: Nov 03, 2012

#### 2. Name of the Device:

Weilin Plastic and Rubber Products Co., Ltd. . Vinyl Examination Powder Free Gloves; Clear; Size Large

#### · 3. Predicate Device Information:

Shiiiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)

#### 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

#### 5. Intended Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body. fluids, waste or environment.

#### 6. Comparison to Predicate Devices:

Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, clear, are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd.(K992821). See Table 7-2.

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#### Discussion of Non-Clinical tests performed for Determination of 7. Substantial Equivalence are as follows:

The standards used for Weilin Plastic and Rubber Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

#### 8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

#### 9. Conclusions:

Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, clear, conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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| | Proposed Device | Predicate Device (K992821) |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Description | Weilin Plastic and Rubber Products Co., Ltd<br>Powder-Free Vinyl Patient Examination<br>Gloves, Clear | Shijiazhuang Hongxiang Powder-free<br>Vinyl Patient Examination Gloves |
| Labeling: Instruction<br>for use | A garment covering the hand and waist area.<br>Clovers have separate sheaths or openings for<br>each finger and the thumb. | Substantially equivalent |
| Labeling: Labels on<br>the carton | Labels include: Product name; color; "single<br>use Only" size, piece count, lot number,<br>distributor name, and manufacturer address. | Substantially equivalent |
| Device Materials | Poly Vinyl Chloride<br>Polyurethane<br>Diisononyl Phthalate (DINP) | Substantially equivalent |
| Before Aging: Tensile<br>Strength(Mpa) and<br>Ultimate Elongations | Average Tensile Strength (Mpa): 16.9<br>Average Ultimate Elongations: 550% | Substantially equivalent |
| After Aging: Tensile<br>Strength(Mpa) and<br>Ultimate Elongations | Average Tensile Strength (Mpa): 14.4<br>Average Ultimate Elongations: 500% | Substantially equivalent |
| Overall Length on<br>Medium Size | Average over 230mm | Substantially equivalent |
| Width of Palm on<br>Medium Size | Average 95mm | Substantially equivalent |
| Palm Thickness | Average 0.073 mm | Substantially equivalent |
| Figure Thickness | Average 0.090 mm | Substantially equivalent |
| Residual Powder | According to ASTM D6124-06 Standard Test<br>Method for Residual Powder on Medical gloves<br>for the determination of residual powder<br>content. Testing result indicates the weight of<br>all types of residual or powder on finished<br>powder-free gloves as < 2 mg per glove and<br>there is no defect glove found according to<br>ASTM D6124-06. | Substantially equivalent |
| Pinhole Results | According to ASTM D5151-06, Testing result<br>indicates pinhole were found less than two<br>pieces gloves out of 125 pieces gloves. AQL<br>2.5 is met. | Substantially equivalent |
| Biocompatibility<br>Result: Primary Skin<br>Irritation | ISO 10993-10 passes | Substantially equivalent |
| Dermal Sensitization | ISO 10993-10 passes | Substantially equivalent |
| Summary of<br>comparison | Weilin Plastic and Rubber Products Co., Ltd. powder-free Vinyl examination gloves,<br>clear color (subject device) and Shijiazhuang Hongxiang, powder-free Vinyl<br>examination glove (predicate device) are substantially equivalent in all technological<br>characteristics, including tensile strength, ultimate elongations size, thickness, residual<br>powder and pinhole. | |

Table 7-2. Side by-Side Comparison of Intended Use, Design, Material, Blocompatibility, and Performance Testing

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 17, 2013

Weilin Plastic and Rubber Products Company, Limited C/O Mr. Ling Zhu Basic Medical Industries, Incorporated 12390 East End Avenue CHINO CA 91710

Re: K123590

> Trade/Device Name: Vinyl Examination Powder Free Gloves, Clear Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 22, 2013 Received: May 16, 2013

Dear Mr. Zhu:

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.

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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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-Sincerely-yours,-

Tejas
Clinic
DAGI

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRIO

FOR

Kwame Ulmer M.S Acting Division Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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Weilin Plastic and Rubber Products Co., Ltd.

601 Jiangjunsan Road Qingzhou, Shandong, China

# INDICATIONS FOR USE

Applicant: Weilin Plastic and Rubber Products Co., Ltd.

510(k) Number:

Vinyl Examination Powder Free Gloves, Clear Device Name:

Indications of Use:

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Prescription Use

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ X

Factory Initials

Elaine S. Mayha

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number; K123590