POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K093439 · Tangshan Pufa Plastic Products Co., Ltd. · LYZ · Dec 22, 2009 · General Hospital

Device Facts

• Record ID: K093439
• Device Name: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
• Applicant: Tangshan Pufa Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Dec 22, 2009
• 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 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

Synthetic vinyl patient examination gloves; disposable; non-sterile; non-colored. Worn by healthcare personnel on hands/fingers during patient examinations. Acts as a physical barrier to prevent cross-contamination of body fluids, waste, or environmental contaminants between patient and examiner. Manufactured to meet ASTM D5250-06 standards. Used in clinical settings.

Clinical Evidence

No clinical data. Bench testing only: physical dimensions, physical properties, and water fill testing (AQL 2.5) per ASTM D5250-06. Biocompatibility testing (primary skin irritation and sensitization) showed no adverse reactions.

Technological Characteristics

Synthetic vinyl material; powder-free (max 2 mg powder/glove); non-sterile; non-colored. Complies with ASTM D5250-06. Tested for physical dimensions and pinhole resistance via FDA 1000 ml water fill test.

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

• Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)

Submission Summary (Full Text)

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K093439

### DEC 22 2009

## 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:

Tangshan Pufa Plastic Products Co., Ltd. Pachigang, Luannan County, Tangshan, Hebei, China Zip Code: 063502

Date summary prepared: October 30, 2009

#### 2. Name of the Device:

Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free

#### 3. Predicate Device Informaton:

Tangshan Pufa Plastic Products Co., 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.

#### Comparison to Predicate Devices: 6.

Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. and Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Powderfree.

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K093439

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

The standards used for Tangshan Pufa Plastic 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, AOL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level 1, 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:

ﺗﺮ

Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination 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 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized bird-like design on the right side. To the left of the bird is a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it.

Public Health Service

DEC 22 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Tangshan Pufa Plastic Products Company, Limited C/O Mr. John Zhao Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

Re: K093439

Trade/Device Name: Patient Vinyl Examination Gloves, Powder free, Non-Sterile,

Non Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 7, 2009 Received: December 8, 2009

Dear Mr. Zhao:

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.

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- Mr. Zhao

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.goy/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Tunney
Notary Public, State of S.C.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K093439

# Tangshan Pufa Plastic Products Co., Ltd.

Pachigang, Luannan County, Tangshan City Hebei, China Phone: [phone]

# INDICATIONS FOR USE

Tangshan Pufa Plastic Products Co., Ltd. Applicant:

510(k) Number: K © 9 343 9

Device Name:

Patient Vinyl Examination Gloves, Powder free, Non-Sterile, Non Colored

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

Elinot D. Clavine-Will

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

KO 93439 510(k) Number: