VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR

K092294 · Bettercare Plastic Products Co., Ltd. · LYZ · Oct 21, 2009 · General Hospital

Device Facts

• Record ID: K092294
• Device Name: VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
• Applicant: Bettercare Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Vinyl co-polymer powder-free examination gloves; blue color. Designed for use by healthcare professionals during patient examinations to provide a barrier against contamination. Device is disposable; worn on hands or fingers. Manufactured to meet ASTM D-5250-06e1 standards for physical dimensions and integrity. Performance verified via water fill testing for pinholes and biocompatibility testing for skin irritation and sensitization. No clinical data provided; safety established through bench testing and comparison to predicate.

Clinical Evidence

No clinical data. Evidence is based on bench testing including physical dimensions, water fill testing (ASTM D5151-06) for pinholes, and biocompatibility testing (primary skin irritation and sensitization).

Technological Characteristics

Vinyl co-polymer material. Powder-free (residual powder < 2 mg/glove). Meets ASTM D-5250-06e1 standards. Tested for pinholes via FDA 1000 ml water fill test (AQL 2.5, inspection level G-1). Biocompatible per skin irritation and sensitization testing.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger 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

• Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)

Submission Summary (Full Text)

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KO92294

EXHIBIT #I Page I of 2

### 510(K) SUMMARY

OCT 2 1 2009

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

The assigned 510(K) number is: __

# 1. Submitter's Identification:

Mr. Guixi Liu Better Care Plastic Products Co., Ltd Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province 050000

Date Summary Prepared: June 30, 2009

# 2. Name of the Device:

Better Care Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color

### 3. Predicate Device Information:

Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)

#### 4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

#### 5. Intended Use:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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#### 6. Comparison to Predicate Devices:

Better Care Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color is substantially equivalent in safety and effectiveness to the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves (Blue Color)

### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

The standards used for Better Care Plastic Products Co., Ltd.'s glove product are bassed on ASTM D-5250-06e1. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.

The FDA 1000 ml. Water Fill Test based on ASTM DS151-06 was also conducted with samplings of AQL 2.5, inspection level G-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 on our labels.

A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection 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:

Better Care Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color conform fully to ASTM D-5250-06e1 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 a black and white seal for the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the bird symbol. The bird symbol is a stylized representation of a human figure embracing a bird.

#### Public Health Service

# DEC 16 2009

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

BetterCare Plastic Products Company, Limited C/O Ms. Jic Liu Project Manager Surprotect, Incorporated 3973 Schaefer Avenue Chino, California 91710

Re: K092294

Trade/Device Name: Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ. Dated: September 30, 2009 Received: October 1, 2009

Dear Ms. Liu:

This letter corrects our substantially equivalent letter of October 21, 2009.

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 (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 cither 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. Liu

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony O. Nockton

Susan Runner, D.D.S., M.A. Acting 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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Attachment A

# INDICATION FOR USE

KD92094 510(K) NUMBER (IF UNKNOW): APPLICANT: Better Care Plastic Products Co., Ltd. DEVICE NAME: Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color

INDICATIONS FOR USE:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Count Use J (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Phil. A.M. Huidiza

oncurrent of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: k092294