NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN

K052666 · Ascend Eagle, Inc. · LYY · Jan 25, 2006 · General Hospital

Device Facts

• Record ID: K052666
• Device Name: NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN
• Applicant: Ascend Eagle, Inc.
• Product Code: LYY · General Hospital
• Decision Date: Jan 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

These patient examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.

Device Story

Non-sterile, powder-free natural or green latex examination gloves; coated with pharmaceutical-grade lanolin and Vitamin E; optional citrus/peppermint scent. Designed for use by healthcare providers in clinical settings to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. Performance verified via ASTM D3578-01a standards, including tensile strength, elongation, and water-tight testing. Features protein labeling claim of <50 micrograms of total water-extractable protein per gram of glove to reduce potential for latex-related allergic reactions.

Clinical Evidence

Bench testing only. Device meets ASTM D3578-01a requirements for physical properties (tensile strength, elongation) and FDA 1000ml water-tight test. Biocompatibility testing passed. Residual protein levels confirmed at <50 micrograms/gram.

Technological Characteristics

Material: Latex. Cuff: Beaded. Powder residue: <2mg/glove. Standards: ASTM D3578-01a, EN 455-1/2/3:2000, ISO 2859-1:1999, ISO 9001:2000. Coating: Lanolin and Vitamin E (USP/Ph.Eur./DAB/BP compliant). Dimensions: 240mm length, 0.13-0.18mm palm thickness. Tensile strength: 21 MPa (before aging), 16 MPa (after aging).

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. 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

• Latex Powder-Free Examination Gloves (K032293)
• Latex Powder-Free Examination Gloves (K013163)

Submission Summary (Full Text)

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#### JAN 2 5 2006

#### SUMMARY PREMARKET 510(k) NOTIFICATION

Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim.

510(k) Number (if known): K052666

Submission Applicant/Official Correspondent:

Jarilyn Lim, President Ascend Eagle Inc. 140-B, Dodd Court American Canyon, CA 94503 707-648-1526 Tel: Fax: [phone]

Submitted: September 26, 2005

#### Description of the Device:

Trade and Proprietary Name: Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2. Predicative Devices: Latex Powder-Free Examination Gloves

#### Intended Use of the Device:

These patient examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.

#### Substantial Equivalence:

Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by US companies. It is Substantially Equivalent to the devices manufactured by SGMP Co., LTD, except by coating, K032293, and by N.S. Uni-Gloves Sdn. Bhd., except by scent, K013163.

#### Summary of Technological Characteristics:

Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove Quality Assurance: In compliance with ASTM D3578-01a, EN 455-1: 2000, EN 455-2: 2000, EN 455-3: 2000, ISO 2859-1:1999 and manufactured under ISO 9001:2000.

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Inspection Parameters:

| Criteria | Inspection Level | AQL |
|-------------------------|------------------|-----|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |

## Physical Properties:

| Dimensions: | |
|-------------------|-----------------------------------------------------|
| Overall Length: | 240 mm minimum |
| Width: | 95 mm minimum (for medium glove) |
| Palm Thickness: | 0.13 to 0.18 mm (at center of palm) |
| Finger Thickness: | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness: | 0.10 to 0.15 mm (at 40mm from the beaded end) |

### BEFORE AGING

Tensile Strength: 21. Mpa minimum Ultimate Elongation:700% minimum Pinhole AQL 1.5 minimum

AFTER AGING

16.0 Mpa minimum 500% minimum 1.5 minimum

#### Biocompatibility:

The biocompatibility test results are as per attached in Appendix B1 and B2 and show that the gloves passed the tests for examination gloves.

#### Residual Protein Level:

The extractable protein content test result is a per attached in Appendix B5 and show that the gloves meets the protein labeling claim level at < 50ugg.

Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.

Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case

Conclusion: These Powder-Free Latex Examination Gloves meet the physical property requirements of ASTM D 3578-01 and the FDA 1000 ml water test both before and after aging. It also meets the protein labeling claim level at < 50uggl

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's wings. The eagle is positioned above a wavy line, likely representing water or a horizon. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2006

Ms. Jarilyn Lim President Ascend Eagle, Incorporated 140-B. Dodd Court American Canyon, California 94503

Re: K052666

Trade/Device Name: Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Color, with or Without Scent (Combined Citrus Peppermint), and with Protein Labeling Claim (50 Micrograms or Less of total water Soluble Protein Per Gram of Glove) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 3, 2006 Received: January 9, 2006

Dear Ms. Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Fxisting 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. Lim

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 (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.

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,

Carl

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

## APPLICANT:

Jarilyn Lim, President Ascend Eagle Inc. 140-B, Dodd Court American Canyon, CA 94503

#### 510(k) NUMBER: K052666

## DEVICE NAME:

Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Color, With or Without Scent (combined Citrus-Peppermint), and with Protein Labeling Claim (50 Micrograms or less of total water soluble protein per Gram of glove)

## Indications For Use:

The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F
and with Protein Labelian Claim (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of 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.

Prescription Use .............................. AND/ OR Per 21 CFR 801.109

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula P. Murphy 12/25/06

U.S. Army General Hospital,
Medical Control, Dental Devices

K052666