DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR

K072401 · Xuzhou Full Sun Medical Products , Ltd. · LYZ · Oct 15, 2007 · General Hospital

Device Facts

• Record ID: K072401
• Device Name: DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
• Applicant: Xuzhou Full Sun Medical Products , Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Abbreviated
• 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 examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable vinyl examination glove; worn on examiner's hand or fingers. Acts as physical barrier to prevent cross-contamination between patient and examiner during medical procedures. Used in clinical or general medical settings by healthcare providers. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data. Bench testing only: physical and dimension testing per ASTM D5250-06; watertight testing per ASTM D-5151-06 (AQL 2.5); residual powder testing per ASTM D6124-06; primary skin irritation and sensitization testing.

Technological Characteristics

Vinyl material; powder-free (residual powder < 2mg/glove). Complies with ASTM D5250-06. Physical dimensions and watertight integrity tested per ASTM D-5151-06. Biocompatible. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or fingers to prevent cross-contamination between patient and examiner. Suitable for over-the-counter use.

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

• Synmertex Company Limited Disposable Powder Free Vinyl Exam Glove (K032172)

Submission Summary (Full Text)

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# 510(K) SUMMARY

K072401

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:

007 1 5 2007

Hsun-Hui Huang Xuzhou Full Sun Medical Products Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu Province China

Date Summary Prepared: August 20, 2007

# 2. Name of the Device:

Xuzhou Full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powder Free

# 3. Predicate Device Information:

Synmertex Company Limited Disposable Powder Free Vinyl Exam Glove (K032172)

# 4. Device description:

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements 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 examiner's hand or finger to prevent contamination between patient and examiner.

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## 6. Comparison to Predicate Devices:

Xuzhou Full Sun Medical Products Ltd's Disposable Vinyl Examination Glove, Powder Free is substantially equivalent to the device manufactured by Synmertex Company Limited(K032172) .

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

The standards used for Xuzhou Full Sun Medical Products Ltd's glove production are Based on ASTM D5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves. Inspection level S-2, AQL 4.0.

The FDA 1000 ml Watertight Test based on ASTM D-5151-06 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 on our labels.

A residual Powder test that based on ASTM D6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims · (contain no more than 2 mg powder per gloves)

## 8. Discussion of Clinic Tests Performed:

Not applicable - There is no Hypoallergenic Claim.

### 9. Conclusions:

Xuzhou Full Sun Medical Products Ltd's Disposable Vinyl Examination Glove, Powder Free conform fully to ASTM D-5250-06 standard as well as applicable 21CFR 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 8 8 33

Ms. Hsun-Hui Huang Manager Xuzhou Full Sun Medical Products Limited Bihe Industry Area Yitang Town, Pizhou County Jiangsu, CHINA

Re: K072401

Trade/Device Name: Disposable Powder Free Vinyl Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 20, 2007 Received: August 27, 2007

Dear Ms. Huang:

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 such 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. Huang

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Clive

Chiu Lin, Ph.D. 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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#### Indications for Use

#### XUZHOU FULL SUN MEDICAL PRODUCTS LTD. Applicant:

Korz 401 510(k) Number (if known): APPLIED

Device Name: Disposable Powder Free Vinyl Exam Glove

Indications for Use:

A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072401