POWDER FREE VINYL PATIENT EXAMINATION GLOVES

K102098 · Hong DI Plastic Products Co., Ltd. · LYZ · Sep 27, 2010 · General Hospital

Device Facts

• Record ID: K102098
• Device Name: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
• Applicant: Hong DI Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Sep 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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.

Device Story

Disposable vinyl patient examination glove; worn by healthcare providers on hands or fingers; acts as a physical barrier to prevent cross-contamination between patient and examiner. Device is non-sterile and intended for single use. Performance verified through physical dimension testing, water leak testing, and biocompatibility assessments.

Clinical Evidence

No clinical data. Bench testing only, including physical dimensions, ASTM D-5250-06e1 compliance, FDA 1000 ml water fill test (AQL 2.5), residual powder testing (ASTM D-6124-06), and biocompatibility (primary skin irritation and sensitization).

Technological Characteristics

Material: Vinyl. Standard: ASTM D-5250-06e1. Type: Powder-free (residual powder ≤ 2 mg/glove). Testing: Water fill test (AQL 2.5), physical dimensions (AQL 4.0). Biocompatibility: Non-irritant, non-sensitizing.

Indications for Use

Indicated for use as a disposable medical 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

• Better Care Plastic Products Co., Ltd Powder Free Vinyl Patient Examination Glove

Submission Summary (Full Text)

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# 510(K) SUMMARY

SEP 2 7 2010

ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔

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: K102098

# l. Owner's Identification:

Mr. Zhiqiang Qiao Hong Di Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, CHINA 050000 Date Summary Prepared: June 4, 2010

# 2. Name of the Device:

Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves

# 3. Predicate Device Information:

Better Care Plastic Products Co., Ltd Powder Free Vinyl Patient Examination Glove

# 4. Device Description:

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 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.

# 6. Comparison to Predicate Devices:

Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Better Care Plastic Products Co., Ltd's Powder Free Vinyl Patient Examination Glove.

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

The standards used for Hong Di Plastic Products Co., Ltd.'s glove production are based 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 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.

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. Labeling:

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

# 9. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

#### 10. Conclusions:

Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves 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. The device herein mentioned is as safe, as effective, and performs as well as or better than the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Hong Di Plastic Products Company, Limited C/O Ms. Jie Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710

SEP 2 7 2010

Re: K102098

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 4, 2010 Received: July 27, 2010

Dear Ms. Jie Liu:

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. 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 (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 vours.

Wh for

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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# Attachment A

# INDICATION FOR USE

SEP 27 2010

510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:

K102098 Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves __ .

## 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.

Over-The-Counter-Use _ Prescription Use AND/ OR (21CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrent of CDRH, Office of eral Hospital Infection Con trol Dental

510(k) Number: