POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

K123869 · Dehai (Shandong) Medical Gloves, Co., Ltd. · LZA · Feb 28, 2013 · General Hospital

Device Facts

• Record ID: K123869
• Device Name: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
• Applicant: Dehai (Shandong) Medical Gloves, Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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)

Device Story

Disposable nitrile examination glove; worn on hands/fingers by healthcare personnel; acts as physical barrier to prevent cross-contamination between patient and examiner. Manufactured from nitrile latex (NBR) with sulfur, accelerator (ZDBC), zinc oxide, potassium hydroxide, and titanium dioxide. Non-sterile, powder-free, blue color. Used in clinical settings. Provides protection during patient examinations.

Clinical Evidence

Bench testing only. Testing included physical dimensions, tensile strength, ultimate elongation, residual powder (ASTM D6124-06), and pinhole testing (ASTM D5151-06). Biocompatibility testing (primary skin irritation and dermal sensitization) conducted per ISO 10993-10 with no adverse reactions reported.

Technological Characteristics

Material: Nitrile Latex (NBR), sulfur, ZDBC accelerator, zinc oxide, potassium hydroxide, titanium dioxide. Standards: ASTM D6319-10. Physical: Powder-free (<2 mg/glove), non-sterile. Dimensions: 230mm length, 95mm palm width, 0.073mm film thickness, 0.090mm finger thickness. Performance: Meets AQL 2.5 for pinholes.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's 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

• Synthetic Nitrile Patient Examination Gloves - Powder Free (K082598)

Submission Summary (Full Text)

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K123869

## FEB 2 8 2013

# 510 (K) SUMMARY

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:

Dehai (Shandong) Medical Gloves, Co., Ltd. No. 216 Huangong Road Linzi District, Zibo, Shandong China

Contact Person: Ray Zhou Tel: [phone] Fax: [phone] Email: [e-mail]

Date summary prepared: Feb. 5, 2013

## 2. Name of the Device:

Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Examination Gloves - Powder Free, Blue Color

## 3. Predicate Device Information:

Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K082598)

### 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.

### ડ. Intended 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)

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## 6. Comparison to Predicate Devices:

Dehai (Shandong) Medical Gloves, Co., Ltd. powder-free nitrile examination gloves (subject device) and Tangshan Zhonghong Pulin Group Co., Ltd. powder-free nitrile examination glove (predicate device) are substantially equivalent in all technological characteristics, including tensile steength, p ultimate elongations size, thickness, residual powder and pinhole. (please kindly refer attached side-by-side comparison of intended use, design, material, physical, biocompatibility and performance testing, Table 7-2)

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

The standards used for Dehai (Shandong) Medical Gloves, Co., Ltd. glove production are based on ASTM-D-6319-10. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Lewell S-2 AOL 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 sensitize toa 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).

## Discussion of Clinical Tests Performed: 8.

Not Applicable - There is no hypoallergenic claim.

#### 9. Conclusions:

Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Patient Examination Gloves, Powder-Free, Blue color, conform fully to ASTM-D-6319-10 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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Side-by-Side Comparison of Intended Use, Design, Material, Biocompatibility, and Performance Testing Table 7-2.

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| Description | Proposed Device | Predicate Device (K082598) |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| | Dehai (Shandong) Medical Gloves, Co., Ltd.<br>Powder-Free Nitrile Examination Gloves, Blue color | Tangshan Zhonghong Pulin Group<br>Co., Ltd. Powder Free Nitrile Patient<br>Examination Gloves |
| Labeling: Instruction<br>for use | A garment covering the hand and wrist 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 | Nitrile Latex (NBR)<br>Sulfur<br>Accelerator, ZDBC<br>Zinc Oxide<br>Potassium Hydroxide<br>Titanium Dioxide and Stabilizer | Substantially equivalent |
| Before Aging: Tensile<br>Strength(Mpa) and<br>Ultimate Elongations | Average Tensile Strength (Mpa): 29.00<br>Average Ultimate Elongations: 750% | Substantially equivalent |
| After Aging: Tensile<br>Strength(Mpa) and<br>Ultimate Elongations | Average Tensile Strength (Mpa): 24.00<br>Average Ultimate Elongations: 700% | Substantially equivalent |
| Overall Length on<br>Medium Size | Average over 230mm | Substantially equivalent |
| Width of Palm on<br>Medium Size | Average 95mm | Substantially equivalent |
| Film 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 | Dehai (Shandong) Medical Gloves, Co., Ltd. powder-free nitrile examination gloves<br>(subject device) and Tangshan Zhonghong Pulin Group Co., Ltd. powder-free nitrile<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. | Substantially equivalent |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## February 28, 2013

Dehai (Shandong) Medical Gloves, Company, Limited C/O Mr. Ray Zhou President Basic Medical Industries, Incorporated 12390 East End Avenue CHINO CA 91710

Re: K123869

Trade/Device Name: Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 10, 2012 Received: December 17, 2012

Dear Mr. Zhou:

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 iddications 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration. Please note: CDRH does not evaluate information related to contract lightlity warranties. We remind you; however; that device labeling must be truthful and not minley

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 devil { in it}, 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

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Anthony D. Watson, B.S., M.S., M.B.A. 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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K123869

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# Dehai (Shandong) Medical Gloves, Co., Ltd.

No. 216 Huangong Road, Linzi District, Zibo, Shandong, China Tel: [phone]

# INDICATIONS FOR USE

Dehai (Shandong) Medical Gloves, Co., Ltd. Applicant:

1123869 510(k) Number:

Device Name: Patient Nitrile Examination Gloves, Powder free, Non-Sterile, Blue Color .

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

Factory Initials

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**510(k) Number:** K123864