WHITE VINYL EXAM GLOVES POWDER FREE

K140322 · Shandong Dawei Medical Products Co., Ltd. · LYZ · Jun 12, 2014 · General Hospital

Device Facts

• Record ID: K140322
• Device Name: WHITE VINYL EXAM GLOVES POWDER FREE
• Applicant: Shandong Dawei Medical Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 12, 2014
• 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 upon the examiner's hands or linger to prevent contamination between patient and examiner.

Device Story

Disposable vinyl patient examination glove; worn on hands/fingers by healthcare examiners; prevents contamination between patient and examiner. Device consists of poly vinyl chloride, polyurethane, and diisononyl phthalate (DINP). Manufactured as powder-free to reduce particulate contamination. Used in clinical settings to provide a protective barrier. Performance verified through tensile strength, elongation, pinhole, and biocompatibility testing.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included physical dimensions, tensile strength (before/after aging), ultimate elongation, pinhole testing (ASTM D5151-06), residual powder content (ASTM D6124-06), and biocompatibility (primary skin irritation and dermal sensitization). All results met ASTM D5250-06 requirements.

Technological Characteristics

Materials: Poly vinyl chloride, polyurethane, diisononyl phthalate (DINP). Standards: ASTM D5250-06 (glove specifications), ASTM D6124-06 (residual powder), ASTM D5151-06 (pinhole). Form factor: Disposable hand/wrist garment. Non-sterile.

Indications for Use

Indicated for use as a 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

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

Submission Summary (Full Text)

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# 510 (K) SUMMARY

# JUN 1 2 2014

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

- 1. Submitter's Identification:
Shandong Dawei Medical Products Co., Ltd. No.50. Yongzhou Road Nanshan Industrial Park, Qingzhou, Shandong, 262500 China

Date summary prepared: June 4, 2014

- 2. Name of the Device:
White Vinyl Exam Gloves Powder Free

- 3. Common name/classification name of the Device:
White Vinyl Exam Gloves Powder Free

- 4. Trade Name
White Vinyl Exam Gloves Powder Free

#### 5. Contact Person:

Sophie Hao, Tel: [phone] Email: [e-mail]

#### 6. Predicate Device Information:

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

#### 7. Device Description:

Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free

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Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.

#### 8. Intended Use:

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or linger to prevent contamination between patient and examiner.

#### (). Comparison to Predicate Devices:

Shandong Dawei Medical Products Co., Ltd. White Vinvi Exam Gloves Powder Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. (K992821)

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

The standards used for Shandong Dawei Medical Products Co., I.td. 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, AQI. 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 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).

- 11. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.

#### l 2. Conclusions:

The conclusion draws from the nonclinical and clinical test that demonstrate that the as safe, as effective, and performs as well as, or better than the legally market predicate device Shijiazhuang Hongxiang Plastic Products Co., Ltd. Powder-free Vinyl Patient Examination Gloves (K992821). Our White Vinvl Exam Gloves Powder Free 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.

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

100 - 100 -

-

| | Proposed Device | Predicate Device (K992821) |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Shandong Dawei Medical Products Co., | Shiiiazhuang Hongxiang |
| Description | Ltd. White Vinyl Exam Gloves Powder | Powder-free Vinyl Patient |
| | Free | Examination Gloves |
| | A garment covering the hand and wrist | A garment covering the hand |
| Labeling: Instruction | area. Clovers have separate openings for | and wrist area. Clovers have |
| for use | each finger and the thumb. | separate openings for each |
| | | finger and the thumb. |
| | | Substantially equivalent |
| | Labels include: Product name: color; | Labels include: Product name; |
| Labeling: Labels on | "single use Only" size, piece count, lot | "single use Only" size, piece |
| the carton | distributor<br>number.<br>name.<br>and | count, distributor name, and |
| | manufacturer address. | manufacturer address. |
| | | Substantially equivalem |
| | disposable device intended<br>র্ব<br>for | A disposable device intended |
| | medical purposes that is worn upon the | for medical purposes that is |
| | examiner's hands or lingers to prevent | upon the examiner's<br>worn |
| Indication For Use | contamination between patient<br>and | hands or fingers to prevent |
| | examiner. | contamination between patient |
| | | and examiner. |
| | | Substantially equivalent |
| | Poly Vinyl Chloride | Poly Vinvl Chloride |
| Device Materials | Polyurethane | Polyurethane |
| | Diisononyl Phthalate (DINP) | Diisononyl Phthalate (DINP) |
| | Average Tensile Strength (Mpa): 16.84 | Tensile<br>Strength<br>Average |
| Before Aging: Tensile | Average Ultimate Elongations: 520% | (Mpa): 16.80 |
| Strength(Mpa) and | | Average Ultimate Elongations: |
| Ultimate Elongations | | 510% |
| | | Substantially equivalent |
| | Average Tensile Strength (Mpa): 14.96 | Average<br>Tensile<br>Strength |
| After Aging: Tensile | Average Ultimate Elongations: 481% | (Mpa): 15 |
| Strength(Mpa) and | | Average Ultimate Elongations: |
| Ultimate Elongations | | 480% |
| | | Substantially equivalent |
| Overall Length on | Average over 232.23mm | Average over 232mm |
| Medium Size | | Substantially equivalent |
| Width of Palm on | Average 95mm | Average 96 mm |
| Medium Size | | Substantially equivalent |
| | Average 0.095 mm | Average 0.096 mm |
| Palm Thickness | | Substantially equivalent |
| Figure Thickness | Average 0.090 mm | Average 0.091 mm |
| | | |
| Residual Powder | According to ASTM D6124-06<br>Standard Test Method for Residual<br>Powder on Medical gloves for the<br>determination of residual powder<br>content. Testing result indicates the<br>weight of all types of residual or powder<br>on finished powder-free gloves as < 2<br>mg per glove and there is no defect<br>glove found according to ASTM<br>D6124-06. | According to ASTM D6124-06<br>the weight of all types of<br>residual or powder on finished<br>powder-free gloves as < 2 mg<br>per glove and there is no defect<br>glove found according to<br>ASTM D6124-06.<br> |
| Pinhole Results | According to ASTM D5151-06. Testing<br>result indicates pinhole were found less<br>than two pieces gloves out of 125 pieces<br>gloves. AQL 2.5 is met. | According to ASTM D5151-<br>06. testing result indicates<br>pinhole were found less than<br>two pieces gloves out of 125<br>pieces gloves. AQL 2.5 is met.<br>Substantially equivalent |
| Biocompatibility<br>Result: Primary Skin<br>Irritation | Under the condition of the study, the<br>device is not an irritant | not an irritant.<br>Substantially equivalent |
| Dermal Sensitization | Under the condition of the study, the<br>device is not a sensitizer | not a sensitizer<br>Substantially equivalent |
| Summary of<br>comparison | Shandong Dawei Medical Products Co., Ltd. White Vinyl Exam Gloves<br>Powder Free (subject device) and Shijiazhuang Hongxiang Powder-free<br>Vinyl Patient Examination Gloves (predicate device) are substantially<br>equivalent in all technological characteristics, including tensile strength,<br>ultimate elongations size, thickness, residual powder and pinhole. | |

6

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100 million in the state

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and the comments of the comments of the comments of

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2014

Shandong Dawei Medical Products Company, Limited C/O Ms. Sophie Hao Official Correspondent Basic Medical Industries Incorporated 12390 East End Avenue Chino, CA 91710

Re: K140322

Trade/Device Name: White Vinyl Exam Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 5, 2014 Received: May 8, 2014

Dear Ms. Hao:

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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Page 2 - Ms. Hao

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 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" (21CFR 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.

.

Sincerely yours.

ਕਿ 1 (ਅਤੇ 1 (ਸੂਬਾ) ਦੇ ਵਿੱਚ ਇੱਕ Telasbri Purobit-Sheth, M.D. Tejashri Purofrit-Sheth; M.O. Clinical Deputy Director STATUS CONSTITUTION DAGRIDIOD DAGRID/ODE/CDRH FOR

> Erin I. Keith, M.S. 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) ド140322

### Device Name

White Vinyl Exam Gloves Powder Free

### Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or lingers 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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